Brackets Detachment Without Primer Among Orthodontic Patients: A Randomized Controlled Trial

Brackets Detachment Without Primer Among Orthodontic Patients: A Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Brackets Detachment Without Primer Among Orthodontic Patients: A Randomized Controlled Trial Umar Hussain, Ferdous Bukhary, Mohammed Mohsen Al Jearah, Muhammad Abdullah Kamran, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6533854/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective To compare the bracket debonding with and without primer in orthodontic patients. Material and Methods This split-mouth randomized controlled trial was conducted on 42 participants. Diagonal quadrants were randomly assigned to either the primer (control) or non-primer (experimental) group. Allocation was concealed in opaque envelopes and revealed at the time of intervention. Both genders, aged 12–30 years, and visiting for the management of malocclusion were included. Patients with dental anomalies, caries, or restorations were excluded. The direct bonding technique was used for the placement of conventional metallic brackets. Participants were followed up for three months, with monthly visits, and bracket failure within each group was recorded. Logistic regression was used to calculate odds, with P ≤ 0.05 considered the level of significance. Results Mean age was 17.41 ± 3.533 years with 45.2% males. Between the two groups, bracket failure rate at first (P = 0.3), second (P = 0.4) and third month (P > 0.99) was differed statistically. The failure rates in the primer and non-primer groups (4.31% vs 5.9%) were similar (OR = 1.386; 95% CI = 0.98–3.34; P = 0.298). However, the failure rate was significantly higher in the non-primer group for males (P = 0.005) and younger age groups (P = 0.016). Conclusion The use of primer may lead to retention of brackets in male patients and younger ages. Trial registration This trial was not registered with any registry Registration : This study was not registered Bracket failure Bonding Failure rate Orthodontic bracket Primer Figures Figure 1 INTRODUCTION The bonding of brackets to enamel surfaces is a critical aspect of orthodontic care, as a reliable and secure bond is essential for the successful outcome of the treatment. 1 The optimal strong bond strength of brackets to enamel is needed withstand the normal intra-oral forces throughout the duration of the treatment, yet weak enough to facilitate debonding at the conclusion care without enamel damage. 2–4 Buonocore introduced composite bonding in orthodontics, replacing traditional banding methods. 5 A primer, an unfilled resin, is an important part of the bonding process making the bond stronger. Literature found that primer helps increase the bond strength, ensuring that the brackets remained securely attached during treatment and can be removed later without damaging the enamel. 6, 7 Alternatively, omitting the primer during the bracket bonding process could help save both financial resources and time by removing a step from the bonding procedure. It has been suggested that a resin phase, lacking filler particles, should be applied in sufficient quantity to the composite surface to fill the micro-porosities in the etched enamel, thus eliminating the need for an unfilled resin. 8 A randomized controlled trial on 50 Swedish patients assessed bracket failure rates with and without primer. The results showed no significant difference between the two groups, with the primer group having a failure rate of 3.1% and the non-primer group 5.5%. This suggests that primer use may not significantly affect bracket failure rates. 9 Another trial was conducted to investigate whether the use of primer is necessary to reduce the failure rate of orthodontic brackets. The study found no statistically significant difference in bracket failure rates between the primer and non-primer groups, with an odds ratio (OR) between 0.95 and 2.25. In terms of the failure rates, the primer group had a failure rate of 11.1%, while the non-primer group had a failure rate of 15.8%. 7 Another study reported that although the bracket failure rate was slightly higher in the non-primer group compared to the primer group (5.79% vs 6.32%), the difference was not statistically significant (p = 0.087). 10 Using primer in orthodontic bracket bonding adds an extra step, increasing chair-side time, procedural costs, and the risk of moisture contamination, which can compromise the bond’s effectiveness. Additionally, primer use is associated with the release of bisphenol-A (BPA), raising potential health concerns, though its impact in orthodontics remains uncertain. There is also a lack of research on primer use in local populations. Existing studies often focus on specific groups, leaving a gap in understanding how primer affects bracket failure rates in the local context. Factors like masticatory function and patient habits can vary across populations, influencing bond durability. This study aims to address these gaps and provide more relevant data for the local population. This study was aimed to compare failure rate of bracket with and without primer in patients undergoing fixed orthodontic treatment MATERIAL AND METHODS Trial design, sampling technique and registration This Split mouth randomized controlled trial was conducted at Orthodontic department, Bacha Khan Dental College, Mardan August 2024 to 2nd February 2025 using non-Probability consecutive sampling and reported according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. This trial was not registered with any trial registry. Sample size To determine the required sample size per group, we use the formula for comparing two proportions in a Z-test: $$\:n=\frac{{\left({Z}_{\alpha\:/2}\cdot\:\sqrt{2P\left(1-P\right)}+{Z}_{\beta\:}\cdot\:\sqrt{{P}_{1}\left(1-{P}_{1}\right)+{P}_{2}\left(1-{P}_{2}\right)}\right)}^{2}}{{\left({P}_{1}-{P}_{2}\right)}^{2}}$$ Where P1 = 11.1% = 0.111 is the failure rate in the primer group, and P2 = 15.8% = 0.158 is the failure rate in the non-primer group 7 . The level of significance (α) is set at 5%, corresponding to a critical value of Zα/2 = 1.96, and the power of the test is 80%, corresponding to Zβ = 0.84. The pooled proportion is given by P = (P1 + P2) / 2. Since there are 20 attachments per patient, the number of patients required per group is given by 827/20, which results in approximately 42 patients per group to achieve the desired power and significance level. Ethical approval and informed consent Approval was obtained from the hospital’s ethical review committee (30/RC/BKMC). The full research protocol was explained to the patients and to the parents of those under 16 years of age, with written consent for treatment. All procedure of the research adhered to Declaration of Helsinki. Eligibility criteria Patients visiting for orthodontic treatment, aged between 12 and 30 years, of both genders, requiring fixed appliances in both arches for dental malocclusion (Angle Class I, II, and III), and Pakistani nationals (verified through their national identity card), were included. Patients with dental anomalies such as enamel fluorosis, caries or restorations on the facial enamel surface, or poor oral hygiene were excluded. Randomization and allocation concealment Forty-two participants were enrolled by a single operator, and randomization was performed using Microsoft Excel 2010. Each participant’s two diagonal quadrants (i.e., upper right and lower left or vice versa) were randomly assigned to either the primer group (control group) or the non-primer group (experimental group). The allocation was done by entering participant numbers into one column in Microsoft Excel 2010, generating random numbers in an adjacent column using the function (= RAND), and sorting them in ascending order. The first assigned diagonal quadrants were allocated to the primer group, while the contralateral diagonal quadrants were assigned to the non-primer group. To ensure allocation concealment, group assignments were sealed in opaque envelopes and revealed only at the time of intervention. Due to the nature of the intervention, only the participants were blinded to the allocation. Bonding procedure The appliances were placed by qualified doctors with more than two years of clinical experience in orthodontic bonding. The participants were divided into two groups: Group I received primer during bonding, while Group II did not use primer randomly. All attachments were 0.022-inch metal Roth or MBT prescription (3M-Unitek Company). The bracket bonding procedure in Group I involved several steps. First, oral prophylaxis was performed using a scaling and polishing without the use of pumice. The bonding surface of the teeth was dried with an air syringe, followed by isolation using a cheek retractor and cotton roll. The enamel surface was etched for 30 seconds with 37% phosphoric acid. After a thorough wash with water and drying using an air syringe, the enamel exhibited a frosted white appearance. A thin layer of primer (Transbonds XT, 3M Unitek incorp) was painted on enamel surface. The brackets were firmly seated, and any flash was removed with a dental explorer. Light curing was performed for 20 seconds using LED light. Bonding was done on one side at a time to ensure effective moisture control. The bracket bonding procedure in Group II followed the same steps as in Group I, except that primer was not applied to the enamel surface. Outcome measurement Demographics like age and gender were recorded. Patients were seen every four weeks over a period of three months to evaluate bond failure. The tooth and arch in which brackets were failed were recorded. A proforma was filled out by a single examiner at each appointment to gather the necessary data. To control for bias and confounders, randomization was applied, inclusion/exclusion criteria were strictly followed, and regression analysis was performed. Statistical analysis R software 4.3.2 was used for data analysis. Frequencies and percentages were calculated for categorical variables while mean and SD were used for quantitative data. The Chi-squared test assessed the differences in failure rates between Group I (primer) and Group II (no primer). Odds ratios (OR) with 95% CIs were determined via logistic regression to examine the association between bond failure (dependent variable) and independent variables, with a two-sided P-value ≤ 0.05 considered significant. Bracket failure was the dependent variable, and bonding method (primer vs. non-primer) was the independent variable, adjusting for confounders like gender, age, location (maxilla/mandible), and side (right/left). RESULTS 42 participants were recruited and randomized equally. Each group received 420 attachments. All participants received the allocated intervention. No losses to follow-up or treatment discontinuations occurred. All attachments were included in the final analysis. (Fig. 1) The mean age was 17.73 years (SD 3.83), with 45.2% males overall. ( Table 1 ) At 1, 2, and 3 months, bracket failure rates did not differ significantly between the primer and non-primer groups (p = 0.28, p = 0.43, and p > 0.99, respectively). ( Table 2 ) Males consistently exhibited higher failure rates than females: at the first month, 7.6% vs. 3.5% (p = 0.008); second month, 7.1% vs. 3.5% (p = 0.018); and third month, 6.1% vs. 2.8% (p = 0.022). Similarly, participants aged 12–17 years had higher failure rates compared to those 18 and above: first month, 7.0% vs. 3.4% (p = 0.02); second month, 7.2% vs. 2.6% (p = 0.003); and third month, 5.7% vs. 2.6% (p = 0.031). No significant differences were observed between arches or sides. ( Table 3 ) ​In a three-month study comparing primer and non-primer bonding methods, males had higher bracket failure rates compared to females at all-time points (1st month: OR = 2.46[1.30–4.63]; 2nd month: OR = 2.33[1.22–4.44]; 3rd month: OR = 2.36[ 1.17–4.74]). Participants aged 12–17 also experienced more failures than those aged 18 and above (1st month: OR = 2.28[1.17–4.45]; 2nd month: OR = 3.07[1.48–6.38]; 3rd month: OR = 2.32[1.09–4.90]). ( Table 4 ) Table 1 Baseline characteristics of the participants in the study Variable characteristics Age (years) Mean ± SD 17.73 ± 3.83 Gender, n(%) Male 19(45.23) Female 23(54.71) Table 2 Comparison of brackets failure among primer and non-primer group at 1st, 2nd and 3rd months Bracket failed at Primer Non-primer P-Value * n(%) n(%) 1st month No 401 (95.5) 394(93.8) 0.28 Yes 19(4.5) 26(6.2) 2nd month No 401(95.5) 396(94.3) 0.43 Yes 19(4.5) 24(5.7) 3rd month No 402(95.7) 402(95.7) > 0.99 Yes 18(4.3) 18(4.3) * chi-square test Table 3 Comparison of bracket failure among genders, arches, sides over three months Bracket failure at 1st month P-Value * Bracket failure at 2nd month P-Value * Bracket failure at 3rd month P-Value * Success Failure No Yes No Yes n (%) n (%) n(%) n(%) n(%) n(%) Gender Male 351 (44.2) 29 (64.4) 0.008 353 (44.3) 27 (62.8) 0.018 357 (44.4) 23 (63.9) 0.022 Female 444(55.8) 16 (35.6) 444 (55.7) 16 (37.2) 447 (55.6) 13 (36.1) Arch Maxilla 403 (50.7) 17 (37.8) 0.09 404 (50.7) 16 (37.2) 0.085 404 (50.2) 16 (44.4) 0.49 Mandible 392 (49.3) 28 (62.2) 393 (49.3) 27 (62.8) 400 (49.8) 20 (55.6) Side Right 394 (49.6) 26 (57.8) 0.28 395 (49.6) 25 (58.1) 0.273 398 (49.5) 22 (61.1) 0.17 Left 401 (50.4) 19 (42.2) 402 (50.4) 18 (41.9) 406 (50.5) 14 (38.9) Age group (years) 12_17 428 (53.8) 32 (71.1) 0.02 427 (53.6) 33 (76.7) 0.003 434 (54) 26 (72.2) 0.031 18 & above 367 46.2) 13 (28.9) 376 (46.4) 10 (23.3) 370 (46) 10 (27.8) *Chi-square test Table 4 Multivariate analysis of bracket failure between primer and non-primer over three month follow up Follow up Covariate Group OR(95% CI) P-value ** 1st month Method of bonding Primer Reference 0.298 Non-primer 1.38(.749, 2.56) Arch Maxilla Reference 0.07 Mandible 1.78(0.95, 3.33) Gender Female Reference 0.005 Male 2.46(1.30, 4.63) Age group ≤ 17 year 2.28(1.17, 4.45) 0.016 ≥ 18 year Reference Side Right 1.37(0.73, 2.55 ) 0.31 Left Reference 2nd month Method of bonding Primer Reference 0.434 Non-primer 1.28(.686, 2.40) Arch Maxilla Reference 0.064 Mandible 1.83(.96, 3.48) Gender Female Reference 0.01 Male 2.33(1.22, 4.44) Age group ≤ 17 year 3.07(1.48, 6.38) 0.003 ≥ 18 year Reference Side Right 1.38(.73, 2.59) 0.315 Left Reference 3rd month Method of bonding primer 0.99(0.5, 1.94) 0.978 Non-primer Reference Arch Maxilla Reference 0.417 Mandible 1.32(0.67, 2.61) Gender Female Reference 0.016 Male 2.36(1.17, 4.74) Age group ≤ 17 year 2.32(1.09, 4.90) 0.028 ≥ 18 year Reference Side Right 1.56(0.78, 3.10) 0.209 Left Reference *OR, Odds ratio; **Logistic regression DISCUSSION We compared bracket failure rates with and without primer in orthodontic patients; with a follow-up period of three months in split mouth randomized controlled trial. The results showed no statistically significant difference in failure rates between the two groups, leading to the failure to reject the null hypothesis. Each quadrant of the mouth was assigned to both the primer and non-primer groups, with one quadrant receiving the primer treatment and the other receiving no primer. This split-mouth design allows each participant to serve as their own control, minimizing individual variability and reducing potential confounders. By using this method, we can directly compare the bracket failure rates between the two groups within the same patient, eliminating the crossover effects that might occur in parallel designs. 10 Attrition bias, which is a common issue in prospective studies due to patient dropout, can lead to misleading results if not properly managed. When excluding dropouts from the data analysis, as seen with the per protocol approach, the outcomes may become distorted. In this study, an intention-to-treat analysis was applied to ensure that all randomized participants were included, thus preserving the randomization process. Fortunately, no participants were lost to follow-up or dropped out. This could be attributed to the strong internal motivation of the patients to complete the study. It was also suggested that the relatively short follow-up period of three months may have contributed to better retention, as opposed to longer durations used in other studies. For instance, some studies have followed patients for 18 months 9 , the entire treatment duration 10 , or 6 months 11 , which could increase dropout rates and complicate the analysis. Our findings indicated no statistically significant difference in bracket failure rates between the primer and non-primer groups. The failure rate was 4.31% with primer and 5.9% without, yielding an odds ratio (OR) of 1.39 (95% CI: 0.98–3.34; P = 0.3). These results are consistent with previous research. A randomized controlled trial involving 50 Swedish patients reported failure rates of 3.1% with primer and 5.5% without, with no significant difference observed. 9 Another study reported failure rates of 11.1% (primer) and 15.8% (non-primer), also showing no statistical significance (OR 95% CI: 0.95–2.25; P = 0.08). 7 Romano et al. conducted a six-month study on 20 Brazilian patients and found no significant difference in failure rates (P = 0.0773). Similarly, a study involving 38 Arab patients with bimaxillary protrusion reported failure rates of 5.8% (primer) and 6.3% (non-primer), again with no statistically significant difference (P = 0.879). 10 Logistic regression analysis was conducted to control for potential confounding variables. The bonding method (with or without primer) was set as the dependent variable, while age, gender, dental arch, and side were included as independent variables. This allowed evaluation of each factor’s effect while adjusting for others. Bracket failure rates were found to be higher in male patients and younger age groups. This may be due to differences in compliance and oral hygiene practices. Older patients are generally more consistent in following care instructions and maintaining appliance hygiene, while younger individuals may be less attentive, leading to a higher risk of bracket failure. The randomized clinical trial by Bazargani et al. 9 also observed higher bracket failure rates in younger patients and males, which is consistent with the findings of the current study. This suggests that age and gender may contribute significantly to bracket failure, possibly due to differences in patient behavior and compliance with orthodontic care. On the other hand, the randomized controlled trial by Nandra et al. 7 found no significant differences in bracket failure rates between different age groups or genders. This inconsistency could be attributed to variations in study design, sample size, or patient characteristics, highlighting the complexity of pinpointing specific risk factors for bracket failure. Furthermore, a study by Barbosa et al. 12 , which explored the effect of age on bracket failure, found a statistically significant difference in failure rates across age groups (P = 0.02). This further supports the idea that age may influence bracket durability, likely due to variations in patient behavior, oral care, and adherence to treatment guidelines across different age groups. The results of our study demonstrated a higher bracket failure rate in the mandibular arch compared to the maxillary arch, though this difference did not reach statistical significance. One possible explanation for the increased failure rate in the mandible is the effect of gravity, which may cause saliva to pool during the bonding process, increasing the risk of contamination and premature detachment of brackets. Similar trends have been observed in previous randomized clinical trials examining bracket failure rates with and without the use of primer, which also reported greater failures in the mandible than the maxilla, but without statistically significant differences. 2, 7, 10, 11 These studies are consistent with our findings. However, Bazargani et al. reported contrasting results in their RCT, where the failure rate in the lower arch was significantly higher than that in the upper arch (p < 0.001). 9 Previous studies found that bracket failure in upper arch varies between 0.8% and 15% and in mandibular arch from 2.3–12.4%. 2, 7, 9–11 Research shows that skin irirtiations, particularly on the hands, are common among orthodontic professionals due to frequent exposure to chemicals used in bonding procedures. To reduce this risk, avoiding the use of primer, which contains unpolymerized components, can be beneficial. Furthermore, not using primer can help reduce chairside time, which in turn lowers the chances of moisture contamination and bond failure. Although a bracket failure rate of up to 10% 14 is generally considered acceptable, clinical experience suggests that some patients experience higher failure rates due to factors like diet and tooth anatomy, which can affect the durability and consistency of the bond. 7 ​A recent meta-analysis comprising four trials reported that patients without primer experienced a higher rate of bond failure compared to those with primer, yielding an odds ratio (OR) of 1.5 (95% confidence interval [CI]: 1.1–2.05; p = 0.01). Notably, one of these studies, which was non-randomized, had a larger sample size and significantly influenced the overall results favoring the use of primer. Additionally, the meta-analysis did not account for the clustering effect inherent in split-mouth designs by calculating the effective sample size, potentially leading to biased conclusions. 15 This study has strengths, such as randomization, which controlled for both known and unknown confounders. Second, the split-mouth study design helped control bias from factors like occlusal interferences, masticatory forces, dental anatomy, brushing habits, and malocclusion types. While randomization aids in reducing bias, these factors may still influence the results. Third, similar malocclusion types may not affect debonding rates. This study has several limitations. First, the follow-up duration was short, which may miss long-term outcomes. Additionally, excluding adult patients means the results apply only to younger individuals. Lastly, although some clinicians accept a bracket failure rate under 5%, the failure rate in our non-primer group was slightly higher at 5.9%. CONCLUSION Within limitations, the results suggest that there is no significant difference in bracket failure rates when primer is not used. However, the use of primer appears to be more beneficial in younger individuals (under 17 years) and males, as these groups showed higher failure rates. Abbreviations BPA Bisphenol–A n Sample size OR Odds ratio P Proportion RCT Randomized controlled trial SD Standard deviation Declarations Ethics approval and consent to participate The study was approved by the Medical Training Institute/Bacha Khan Medical College, Mardan, Pakistan (reference number: 30/RC/BKMC). Informed written consent was obtained from all participants and/or their guardians in the case of those under the age of 16 years prior to their enrollment in the study. Consent for publication Not applicable. This study does not contain any individual person’s data in any form (including images or videos). Availability of data and materials Data of current study are available from the corresponding author on reasonable request. However, for privacy reasons, no individual data allowing identification of participants (e.g., videos) can be provided. Competing Interests The authors declare that they have no financial, personal, or professional conflicts of interest that could have influenced the work reported in this manuscript. No support or funding was received from any organization that could be perceived to influence the findings, and there are no affiliations or relationships that may be viewed as potential competing interests. Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was self-funded by the authors. Authors' contributions Umar Hussain - (Conceptualization [equal], (Data collection [equal], Writing—review & editing [equal]), final approval Ferdous Bukhary - (Conceptualization [equal], (Data curation [equal], Investigation [equal], Methodology [equal], Writing—review & editing [equal]), final approval Mohammed Mohsen Al Jearah - (Conceptualization [equal], (Data entry [equal], Writing—review & editing [equal]), final approval Muhammad Abdullah Kamran - (Conceptualization [equal], literature review [equal], Methodology [equal], Writing—review & editing [equal]), final approval Ali Alqerban - (Conceptualization [equal], data interpretation [equal], Writing—review & editing [equal]), final approval Waqas Naseem - (data entry [equal], data curation[equal], literature review [equal], Methodology [equal], Writing—review & editing [equal]), final approval Trial registration This trial was not registered with any registry Acknowledgements We are grateful to the administrative staff and faculty members of the participating dental colleges for their support and cooperation throughout the research process. 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Effect of enamel surface treatment on the bond strength of metallic brackets in rebonding process. Eur J Orthod. 2012;34(6):773-7. Nandhra SS, Littlewood SJ, Houghton N, Luther F, Prabhu J, Munyombwe T, et al. Do we need primer for orthodontic bonding? A randomized controlled trial. Eur J Orthod. 2015;37(2):147-55. Zhou Y, Wu S, Ma Y, Zhang H, Zeng X, Wu F, et al. Recent advances in organic/composite phase change materials for energy storage. ES Energy Envir. 2020;9(12):28-40. Bazargani F, Magnuson A, Löthgren H, Kowalczyk A. Orthodontic bonding with and without primer: a randomized controlled trial. Eur J Orthod. 2016;38(5):503-7. Rai AK. Evaluation of bracket failure rate in orthodontic patients bonded with and without primer. Saudi J Dent Res. 2015;6(1):48-53. Romano FL, Correr AB, Correr-Sobrinho L, Magnani MBBdA, Ruellas ACdO. Clinical evaluation of the failure rates of metallic brackets. J Appl Oral Sci. 2012;20(2):228-34. Barbosa IV, de Miranda Ladewig V, Almeida-Pedrin RR, Cardoso MA, Junior JFS, Conti ACdCF. The association between patient’s compliance and age with the bonding failure of orthodontic brackets: a cross-sectional study. Prog Orthod. 2018;19(1):1-5. Jacobsen N, Aasenden R, Hensten-Pettersen A. Occupational health complaints and adverse patient reactions as perceived by personnel in public dentistry. Comm Dent Oral Epidemiol. 1991;19(3):155-9. Ozer M, Bayram M, Dincyurek C, Tokalak F. Clinical bond failure rates of adhesive precoated self-ligating brackets using a self-etching primer. Angle Orthod. 2014;84(1):155-60. Rajamuthu T, Rajagopalan A, Venkatachalapathy A, Krishnan P, Munusamy N, Asokan U. Orthodontic bracket failure rate after bonding with and without primer–a systematic review and meta-analysis. Int Orthod. 2025;23(1):100934. Additional Declarations No competing interests reported. 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08:53:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6533854/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6533854/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":82620240,"identity":"f89c0f81-c328-45d5-b2c1-0b623c3f7309","added_by":"auto","created_at":"2025-05-13 12:13:01","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":147459,"visible":true,"origin":"","legend":"\u003cp\u003eFlow chart for selecting participants\u003c/p\u003e","description":"","filename":"Fig1.flowchart.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6533854/v1/d9ee57f1aea13740f82cdb5f.jpg"},{"id":84928341,"identity":"9e4b2df4-fa82-4b08-9008-f52fb52d77de","added_by":"auto","created_at":"2025-06-19 00:46:34","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1021784,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6533854/v1/6320279a-324b-440e-afbd-57721c4c17af.pdf"},{"id":82620245,"identity":"1d530a7e-bf20-49f3-8c7b-e8c94727ed96","added_by":"auto","created_at":"2025-05-13 12:13:01","extension":"doc","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":223232,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORT2010Checklist.doc","url":"https://assets-eu.researchsquare.com/files/rs-6533854/v1/85ab69117446f35d15870d7e.doc"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eBrackets Detachment Without Primer Among Orthodontic Patients: A Randomized Controlled Trial\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eThe bonding of brackets to enamel surfaces is a critical aspect of orthodontic care, as a reliable and secure bond is essential for the successful outcome of the treatment.\u003csup\u003e1\u003c/sup\u003e The optimal strong bond strength of brackets to enamel is needed withstand the normal intra-oral forces throughout the duration of the treatment, yet weak enough to facilitate debonding at the conclusion care without enamel damage.\u003csup\u003e2\u0026ndash;4\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eBuonocore introduced composite bonding in orthodontics, replacing traditional banding methods.\u003csup\u003e5\u003c/sup\u003e A primer, an unfilled resin, is an important part of the bonding process making the bond stronger. Literature found that primer helps increase the bond strength, ensuring that the brackets remained securely attached during treatment and can be removed later without damaging the enamel.\u003csup\u003e6, 7\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAlternatively, omitting the primer during the bracket bonding process could help save both financial resources and time by removing a step from the bonding procedure. It has been suggested that a resin phase, lacking filler particles, should be applied in sufficient quantity to the composite surface to fill the micro-porosities in the etched enamel, thus eliminating the need for an unfilled resin.\u003csup\u003e8\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eA randomized controlled trial on 50 Swedish patients assessed bracket failure rates with and without primer. The results showed no significant difference between the two groups, with the primer group having a failure rate of 3.1% and the non-primer group 5.5%. This suggests that primer use may not significantly affect bracket failure rates.\u003csup\u003e9\u003c/sup\u003e Another trial was conducted to investigate whether the use of primer is necessary to reduce the failure rate of orthodontic brackets. The study found no statistically significant difference in bracket failure rates between the primer and non-primer groups, with an odds ratio (OR) between 0.95 and 2.25. In terms of the failure rates, the primer group had a failure rate of 11.1%, while the non-primer group had a failure rate of 15.8%.\u003csup\u003e7\u003c/sup\u003e Another study reported that although the bracket failure rate was slightly higher in the non-primer group compared to the primer group (5.79% vs 6.32%), the difference was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.087).\u003csup\u003e10\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eUsing primer in orthodontic bracket bonding adds an extra step, increasing chair-side time, procedural costs, and the risk of moisture contamination, which can compromise the bond\u0026rsquo;s effectiveness. Additionally, primer use is associated with the release of bisphenol-A (BPA), raising potential health concerns, though its impact in orthodontics remains uncertain. There is also a lack of research on primer use in local populations. Existing studies often focus on specific groups, leaving a gap in understanding how primer affects bracket failure rates in the local context. Factors like masticatory function and patient habits can vary across populations, influencing bond durability. This study aims to address these gaps and provide more relevant data for the local population.\u003c/p\u003e \u003cp\u003eThis study was aimed to compare failure rate of bracket with and without primer in patients undergoing fixed orthodontic treatment\u003c/p\u003e"},{"header":"MATERIAL AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eTrial design, sampling technique and registration\u003c/h2\u003e \u003cp\u003e This Split mouth randomized controlled trial was conducted at Orthodontic department, Bacha Khan Dental College, Mardan August 2024 to 2nd February 2025 using non-Probability consecutive sampling and reported according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. This trial was not registered with any trial registry.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eSample size\u003c/h3\u003e\n\u003cp\u003eTo determine the required sample size per group, we use the formula for comparing two proportions in a Z-test:\u003cdiv id=\"Equa\" class=\"Equation\"\u003e\u003cdiv format=\"TEX\" class=\"mathdisplay\" id=\"FileID_Equa\" name=\"EquationSource\"\u003e\n$$\\:n=\\frac{{\\left({Z}_{\\alpha\\:/2}\\cdot\\:\\sqrt{2P\\left(1-P\\right)}+{Z}_{\\beta\\:}\\cdot\\:\\sqrt{{P}_{1}\\left(1-{P}_{1}\\right)+{P}_{2}\\left(1-{P}_{2}\\right)}\\right)}^{2}}{{\\left({P}_{1}-{P}_{2}\\right)}^{2}}$$\u003c/div\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eWhere P1\u0026thinsp;=\u0026thinsp;11.1% = 0.111 is the failure rate in the primer group, and P2\u0026thinsp;=\u0026thinsp;15.8% = 0.158 is the failure rate in the non-primer group\u003csup\u003e7\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe level of significance (α) is set at 5%, corresponding to a critical value of Zα/2\u0026thinsp;=\u0026thinsp;1.96, and the power of the test is 80%, corresponding to Zβ\u0026thinsp;=\u0026thinsp;0.84.\u003c/p\u003e \u003cp\u003eThe pooled proportion is given by P = (P1\u0026thinsp;+\u0026thinsp;P2) / 2. Since there are 20 attachments per patient, the number of patients required per group is given by 827/20, which results in approximately 42 patients per group to achieve the desired power and significance level.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eEthical approval\u003c/strong\u003e \u003cp\u003e \u003cb\u003eand informed consent\u003c/b\u003e \u003c/p\u003e \u003c/p\u003e \u003cp\u003e Approval was obtained from the hospital\u0026rsquo;s ethical review committee (30/RC/BKMC). The full research protocol was explained to the patients and to the parents of those under 16 years of age, with written consent for treatment. All procedure of the research adhered to Declaration of Helsinki.\u003c/p\u003e\n\u003ch3\u003eEligibility criteria\u003c/h3\u003e\n\u003cp\u003ePatients visiting for orthodontic treatment, aged between 12 and 30 years, of both genders, requiring fixed appliances in both arches for dental malocclusion (Angle Class I, II, and III), and Pakistani nationals (verified through their national identity card), were included. Patients with dental anomalies such as enamel fluorosis, caries or restorations on the facial enamel surface, or poor oral hygiene were excluded.\u003c/p\u003e\n\u003ch3\u003eRandomization and allocation concealment\u003c/h3\u003e\n\u003cp\u003eForty-two participants were enrolled by a single operator, and randomization was performed using Microsoft Excel 2010. Each participant\u0026rsquo;s two diagonal quadrants (i.e., upper right and lower left or vice versa) were randomly assigned to either the primer group (control group) or the non-primer group (experimental group). The allocation was done by entering participant numbers into one column in Microsoft Excel 2010, generating random numbers in an adjacent column using the function (=\u0026thinsp;RAND), and sorting them in ascending order. The first assigned diagonal quadrants were allocated to the primer group, while the contralateral diagonal quadrants were assigned to the non-primer group. To ensure allocation concealment, group assignments were sealed in opaque envelopes and revealed only at the time of intervention. Due to the nature of the intervention, only the participants were blinded to the allocation.\u003c/p\u003e\n\u003ch3\u003eBonding procedure\u003c/h3\u003e\n\u003cp\u003eThe appliances were placed by qualified doctors with more than two years of clinical experience in orthodontic bonding. The participants were divided into two groups: Group I received primer during bonding, while Group II did not use primer randomly. All attachments were 0.022-inch metal Roth or MBT prescription (3M-Unitek Company). The bracket bonding procedure in Group I involved several steps. First, oral prophylaxis was performed using a scaling and polishing without the use of pumice. The bonding surface of the teeth was dried with an air syringe, followed by isolation using a cheek retractor and cotton roll. The enamel surface was etched for 30 seconds with 37% phosphoric acid. After a thorough wash with water and drying using an air syringe, the enamel exhibited a frosted white appearance. A thin layer of primer (Transbonds XT, 3M Unitek incorp) was painted on enamel surface. The brackets were firmly seated, and any flash was removed with a dental explorer. Light curing was performed for 20 seconds using LED light. Bonding was done on one side at a time to ensure effective moisture control. The bracket bonding procedure in Group II followed the same steps as in Group I, except that primer was not applied to the enamel surface.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eOutcome measurement\u003c/h2\u003e \u003cp\u003eDemographics like age and gender were recorded. Patients were seen every four weeks over a period of three months to evaluate bond failure. The tooth and arch in which brackets were failed were recorded. A proforma was filled out by a single examiner at each appointment to gather the necessary data. To control for bias and confounders, randomization was applied, inclusion/exclusion criteria were strictly followed, and regression analysis was performed.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eR software 4.3.2 was used for data analysis. Frequencies and percentages were calculated for categorical variables while mean and SD were used for quantitative data. The Chi-squared test assessed the differences in failure rates between Group I (primer) and Group II (no primer). Odds ratios (OR) with 95% CIs were determined via logistic regression to examine the association between bond failure (dependent variable) and independent variables, with a two-sided P-value\u0026thinsp;\u0026le;\u0026thinsp;0.05 considered significant. Bracket failure was the dependent variable, and bonding method (primer vs. non-primer) was the independent variable, adjusting for confounders like gender, age, location (maxilla/mandible), and side (right/left).\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003e42 participants were recruited and randomized equally. Each group received 420 attachments. All participants received the allocated intervention. No losses to follow-up or treatment discontinuations occurred. All attachments were included in the final analysis. \u003cb\u003e(Fig.\u0026nbsp;1)\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe mean age was 17.73 years (SD 3.83), with 45.2% males overall. \u003cb\u003e(\u003c/b\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e At 1, 2, and 3 months, bracket failure rates did not differ significantly between the primer and non-primer groups (p\u0026thinsp;=\u0026thinsp;0.28, p\u0026thinsp;=\u0026thinsp;0.43, and p\u0026thinsp;\u0026gt;\u0026thinsp;0.99, respectively). \u003cb\u003e(\u003c/b\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e\u003c/p\u003e \u003cp\u003eMales consistently exhibited higher failure rates than females: at the first month, 7.6% vs. 3.5% (p\u0026thinsp;=\u0026thinsp;0.008); second month, 7.1% vs. 3.5% (p\u0026thinsp;=\u0026thinsp;0.018); and third month, 6.1% vs. 2.8% (p\u0026thinsp;=\u0026thinsp;0.022). Similarly, participants aged 12\u0026ndash;17 years had higher failure rates compared to those 18 and above: first month, 7.0% vs. 3.4% (p\u0026thinsp;=\u0026thinsp;0.02); second month, 7.2% vs. 2.6% (p\u0026thinsp;=\u0026thinsp;0.003); and third month, 5.7% vs. 2.6% (p\u0026thinsp;=\u0026thinsp;0.031). No significant differences were observed between arches or sides. \u003cb\u003e(\u003c/b\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e\u003c/p\u003e \u003cp\u003e​In a three-month study comparing primer and non-primer bonding methods, males had higher bracket failure rates compared to females at all-time points (1st month: OR\u0026thinsp;=\u0026thinsp;2.46[1.30\u0026ndash;4.63]; 2nd month: OR\u0026thinsp;=\u0026thinsp;2.33[1.22\u0026ndash;4.44]; 3rd month: OR\u0026thinsp;=\u0026thinsp;2.36[ 1.17\u0026ndash;4.74]). Participants aged 12\u0026ndash;17 also experienced more failures than those aged 18 and above (1st month: OR\u0026thinsp;=\u0026thinsp;2.28[1.17\u0026ndash;4.45]; 2nd month: OR\u0026thinsp;=\u0026thinsp;3.07[1.48\u0026ndash;6.38]; 3rd month: OR\u0026thinsp;=\u0026thinsp;2.32[1.09\u0026ndash;4.90]). \u003cb\u003e(\u003c/b\u003eTable\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline characteristics of the participants in the study\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003echaracteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17.73\u0026thinsp;\u0026plusmn;\u0026thinsp;3.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGender, n(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19(45.23)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23(54.71)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of brackets failure among primer and non-primer group at 1st, 2nd and 3rd months\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c2\" namest=\"c1\" rowspan=\"2\"\u003e \u003cp\u003eBracket failed at\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePrimer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNon-primer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eP-Value\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003en(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003en(%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e1st month\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e401 (95.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e394(93.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.28\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19(4.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26(6.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e2nd month\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e401(95.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e396(94.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.43\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19(4.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24(5.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e3rd month\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e402(95.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e402(95.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;0.99\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18(4.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18(4.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003e\u003csup\u003e*\u003c/sup\u003echi-square test\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of bracket failure among genders, arches, sides over three months\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"11\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" morerows=\"2\" nameend=\"c2\" namest=\"c1\" rowspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eBracket failure at 1st month\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eP-Value\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003eBracket failure at 2nd month\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eP-Value\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c10\" namest=\"c9\"\u003e \u003cp\u003eBracket failure at 3rd month\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eP-Value\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSuccess\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eFailure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003en (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003en(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003en(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003en(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003en(%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e351 (44.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e29 (64.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.008\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e353 (44.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e27 (62.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.018\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e357 (44.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e23 (63.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c11\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.022\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e444(55.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16 (35.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e444 (55.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e16 (37.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e447 (55.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e13 (36.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eArch\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMaxilla\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e403 (50.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17 (37.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e404 (50.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e16 (37.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.085\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e404 (50.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e16 (44.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c11\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.49\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMandible\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e392 (49.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e28 (62.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e393 (49.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e27 (62.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e400 (49.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e20 (55.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eSide\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e394 (49.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26 (57.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e395 (49.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e25 (58.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e398 (49.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e22 (61.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c11\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.17\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLeft\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e401 (50.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e19 (42.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e402 (50.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e18 (41.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e406 (50.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e14 (38.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAge group (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12_17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e428 (53.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e32 (71.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e427 (53.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e33 (76.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.003\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e434 (54)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e26 (72.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c11\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.031\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18 \u0026amp; above\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e367 46.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13 (28.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e376 (46.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10 (23.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e370 (46)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e10 (27.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"11\"\u003e*Chi-square test\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eMultivariate analysis of bracket failure between primer and non-primer over three month follow up\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFollow up\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCovariate\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eOR(95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP-value\u003csup\u003e**\u003c/sup\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"9\" rowspan=\"10\"\u003e \u003cp\u003e\u003cb\u003e1st month\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eMethod of bonding\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePrimer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.298\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNon-primer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.38(.749, 2.56)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eArch\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMaxilla\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.07\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMandible\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.78(0.95, 3.33)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eGender\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.005\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.46(1.30, 4.63)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAge group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;17 year\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.28(1.17, 4.45)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.016\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;18 year\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eSide\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eRight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.37(0.73, 2.55\u0026nbsp;)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.31\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLeft\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"9\" rowspan=\"10\"\u003e \u003cp\u003e\u003cb\u003e2nd month\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eMethod of bonding\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePrimer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.434\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNon-primer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.28(.686, 2.40)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eArch\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMaxilla\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.064\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMandible\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.83(.96, 3.48)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eGender\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.33(1.22, 4.44)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAge group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;17 year\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.07(1.48, 6.38)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.003\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;18 year\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eSide\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eRight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.38(.73, 2.59)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.315\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLeft\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"9\" rowspan=\"10\"\u003e \u003cp\u003e\u003cb\u003e3rd month\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eMethod of bonding\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eprimer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.99(0.5, 1.94)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.978\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNon-primer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eArch\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMaxilla\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.417\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMandible\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.32(0.67, 2.61)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eGender\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.016\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.36(1.17, 4.74)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eAge group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026le;\u0026thinsp;17 year\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.32(1.09, 4.90)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.028\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u0026ge;\u0026thinsp;18 year\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e\u003cb\u003eSide\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eRight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.56(0.78, 3.10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e0.209\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eLeft\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eReference\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003e*OR, Odds ratio; **Logistic regression\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eWe compared bracket failure rates with and without primer in orthodontic patients; with a follow-up period of three months in split mouth randomized controlled trial. The results showed no statistically significant difference in failure rates between the two groups, leading to the failure to reject the null hypothesis.\u003c/p\u003e \u003cp\u003eEach quadrant of the mouth was assigned to both the primer and non-primer groups, with one quadrant receiving the primer treatment and the other receiving no primer. This split-mouth design allows each participant to serve as their own control, minimizing individual variability and reducing potential confounders. By using this method, we can directly compare the bracket failure rates between the two groups within the same patient, eliminating the crossover effects that might occur in parallel designs.\u003csup\u003e10\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAttrition bias, which is a common issue in prospective studies due to patient dropout, can lead to misleading results if not properly managed. When excluding dropouts from the data analysis, as seen with the per protocol approach, the outcomes may become distorted. In this study, an intention-to-treat analysis was applied to ensure that all randomized participants were included, thus preserving the randomization process. Fortunately, no participants were lost to follow-up or dropped out. This could be attributed to the strong internal motivation of the patients to complete the study. It was also suggested that the relatively short follow-up period of three months may have contributed to better retention, as opposed to longer durations used in other studies. For instance, some studies have followed patients for 18 months\u003csup\u003e9\u003c/sup\u003e, the entire treatment duration\u003csup\u003e10\u003c/sup\u003e, or 6 months\u003csup\u003e11\u003c/sup\u003e, which could increase dropout rates and complicate the analysis.\u003c/p\u003e \u003cp\u003eOur findings indicated no statistically significant difference in bracket failure rates between the primer and non-primer groups. The failure rate was 4.31% with primer and 5.9% without, yielding an odds ratio (OR) of 1.39 (95% CI: 0.98\u0026ndash;3.34; P\u0026thinsp;=\u0026thinsp;0.3). These results are consistent with previous research. A randomized controlled trial involving 50 Swedish patients reported failure rates of 3.1% with primer and 5.5% without, with no significant difference observed.\u003csup\u003e9\u003c/sup\u003e Another study reported failure rates of 11.1% (primer) and 15.8% (non-primer), also showing no statistical significance (OR 95% CI: 0.95\u0026ndash;2.25; P\u0026thinsp;=\u0026thinsp;0.08).\u003csup\u003e7\u003c/sup\u003e Romano et al. conducted a six-month study on 20 Brazilian patients and found no significant difference in failure rates (P\u0026thinsp;=\u0026thinsp;0.0773). Similarly, a study involving 38 Arab patients with bimaxillary protrusion reported failure rates of 5.8% (primer) and 6.3% (non-primer), again with no statistically significant difference (P\u0026thinsp;=\u0026thinsp;0.879).\u003csup\u003e10\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eLogistic regression analysis was conducted to control for potential confounding variables. The bonding method (with or without primer) was set as the dependent variable, while age, gender, dental arch, and side were included as independent variables. This allowed evaluation of each factor\u0026rsquo;s effect while adjusting for others. Bracket failure rates were found to be higher in male patients and younger age groups. This may be due to differences in compliance and oral hygiene practices. Older patients are generally more consistent in following care instructions and maintaining appliance hygiene, while younger individuals may be less attentive, leading to a higher risk of bracket failure.\u003c/p\u003e \u003cp\u003eThe randomized clinical trial by Bazargani et al.\u003csup\u003e9\u003c/sup\u003e also observed higher bracket failure rates in younger patients and males, which is consistent with the findings of the current study. This suggests that age and gender may contribute significantly to bracket failure, possibly due to differences in patient behavior and compliance with orthodontic care. On the other hand, the randomized controlled trial by Nandra et al.\u003csup\u003e7\u003c/sup\u003e found no significant differences in bracket failure rates between different age groups or genders. This inconsistency could be attributed to variations in study design, sample size, or patient characteristics, highlighting the complexity of pinpointing specific risk factors for bracket failure. Furthermore, a study by Barbosa et al.\u003csup\u003e12\u003c/sup\u003e, which explored the effect of age on bracket failure, found a statistically significant difference in failure rates across age groups (P\u0026thinsp;=\u0026thinsp;0.02). This further supports the idea that age may influence bracket durability, likely due to variations in patient behavior, oral care, and adherence to treatment guidelines across different age groups.\u003c/p\u003e \u003cp\u003eThe results of our study demonstrated a higher bracket failure rate in the mandibular arch compared to the maxillary arch, though this difference did not reach statistical significance. One possible explanation for the increased failure rate in the mandible is the effect of gravity, which may cause saliva to pool during the bonding process, increasing the risk of contamination and premature detachment of brackets. Similar trends have been observed in previous randomized clinical trials examining bracket failure rates with and without the use of primer, which also reported greater failures in the mandible than the maxilla, but without statistically significant differences.\u003csup\u003e2, 7, 10, 11\u003c/sup\u003e These studies are consistent with our findings. However, Bazargani et al. reported contrasting results in their RCT, where the failure rate in the lower arch was significantly higher than that in the upper arch (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003csup\u003e9\u003c/sup\u003e Previous studies found that bracket failure in upper arch varies between 0.8% and 15% and in mandibular arch from 2.3\u0026ndash;12.4%.\u003csup\u003e2, 7, 9\u0026ndash;11\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eResearch shows that skin irirtiations, particularly on the hands, are common among orthodontic professionals due to frequent exposure to chemicals used in bonding procedures. To reduce this risk, avoiding the use of primer, which contains unpolymerized components, can be beneficial. Furthermore, not using primer can help reduce chairside time, which in turn lowers the chances of moisture contamination and bond failure. Although a bracket failure rate of up to 10%\u003csup\u003e14\u003c/sup\u003e is generally considered acceptable, clinical experience suggests that some patients experience higher failure rates due to factors like diet and tooth anatomy, which can affect the durability and consistency of the bond. \u003csup\u003e7\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e​A recent meta-analysis comprising four trials reported that patients without primer experienced a higher rate of bond failure compared to those with primer, yielding an odds ratio (OR) of 1.5 (95% confidence interval [CI]: 1.1\u0026ndash;2.05; p\u0026thinsp;=\u0026thinsp;0.01). Notably, one of these studies, which was non-randomized, had a larger sample size and significantly influenced the overall results favoring the use of primer. Additionally, the meta-analysis did not account for the clustering effect inherent in split-mouth designs by calculating the effective sample size, potentially leading to biased conclusions.\u003csup\u003e15\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThis study has strengths, such as randomization, which controlled for both known and unknown confounders. Second, the split-mouth study design helped control bias from factors like occlusal interferences, masticatory forces, dental anatomy, brushing habits, and malocclusion types. While randomization aids in reducing bias, these factors may still influence the results. Third, similar malocclusion types may not affect debonding rates. This study has several limitations. First, the follow-up duration was short, which may miss long-term outcomes. Additionally, excluding adult patients means the results apply only to younger individuals. Lastly, although some clinicians accept a bracket failure rate under 5%, the failure rate in our non-primer group was slightly higher at 5.9%.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eWithin limitations, the results suggest that there is no significant difference in bracket failure rates when primer is not used. However, the use of primer appears to be more beneficial in younger individuals (under 17 years) and males, as these groups showed higher failure rates.\u003c/p\u003e "},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBPA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBisphenol\u0026ndash;A\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003en\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSample size\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eOR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eOdds ratio\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eProportion\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRandomized controlled trial\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSD\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u0026nbsp;Ethics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was approved by the Medical Training Institute/Bacha Khan Medical College, Mardan, Pakistan (reference number: 30/RC/BKMC). Informed written consent was obtained from all participants and/or their guardians in the case of those under the age of 16 years prior to their enrollment in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. This study does not contain any individual person\u0026rsquo;s data in any form (including images or videos).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData of current study are available from the corresponding author on reasonable request. However, for privacy reasons, no individual data allowing identification of participants (e.g., videos) can be provided.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no financial, personal, or professional conflicts of interest that could have influenced the work reported in this manuscript. No support or funding was received from any organization that could be perceived to influence the findings, and there are no affiliations or relationships that may be viewed as potential competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was self-funded by the authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eUmar Hussain -\u0026nbsp;\u003c/strong\u003e(Conceptualization [equal], (Data collection [equal], Writing\u0026mdash;review \u0026amp; editing [equal]), final approval\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFerdous Bukhary\u0026nbsp;\u003c/strong\u003e- (Conceptualization [equal], (Data curation [equal], Investigation [equal], Methodology [equal], Writing\u0026mdash;review \u0026amp; editing [equal]), final approval\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMohammed Mohsen Al Jearah -\u0026nbsp;\u003c/strong\u003e(Conceptualization [equal], (Data entry [equal], Writing\u0026mdash;review \u0026amp; editing [equal]), final approval\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMuhammad Abdullah Kamran -\u003c/strong\u003e\u0026nbsp; (Conceptualization [equal], literature review [equal], Methodology [equal], Writing\u0026mdash;review \u0026amp; editing [equal]), final approval\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAli Alqerban -\u0026nbsp;\u003c/strong\u003e(Conceptualization [equal], data interpretation [equal], Writing\u0026mdash;review \u0026amp; editing [equal]), final approval\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWaqas Naseem\u0026nbsp;\u003c/strong\u003e- (data entry [equal], data curation[equal], \u0026nbsp;literature review [equal], Methodology [equal], Writing\u0026mdash;review \u0026amp; editing [equal]), final approval\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis trial was not registered with any registry\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe are grateful to the administrative staff and faculty members of the participating dental colleges for their support and cooperation throughout the research process.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eNaqvi ZA, Shaikh S, Pasha Z. Evaluation of Bond Failure Rate of Orthodontic Brackets Bonded with Green Gloo-Two Way Color Changes Adhesive: A Clinical Study. Ethiop J Health Sci. 2019;29(2):187-94.\u003c/li\u003e\n \u003cli\u003eKrishnan S, Pandian S, Rajagopal R. Six-month bracket failure rate with a flowable composite: A split-mouth randomized controlled trial. Dental Press J Orthod. 2017;22(2):69-76.\u003c/li\u003e\n \u003cli\u003eVaheed N, Gupta M, David S, Sam G, Ramanna P, Bhagvandas S. In vitro Analysis of Shear Bond Strength and Adhesive Remnant Index of Stainless Steel Brackets with Different Adhesive Systems to Enamel. J Contemp Dent Pract. 2018;19(9):1047-51.\u003c/li\u003e\n \u003cli\u003eAlmosa N, Zafar H. Incidence of orthodontic brackets detachment during orthodontic treatment: A systematic review. Pak J Med Sci. 2018;34(3):744-50.\u003c/li\u003e\n \u003cli\u003eBuonocore MG. A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces. J Dent Res. 1955;34(6):849-53.\u003c/li\u003e\n \u003cli\u003ePakshir H, Zarif Najafi H, Hajipour S. Effect of enamel surface treatment on the bond strength of metallic brackets in rebonding process. Eur J Orthod. 2012;34(6):773-7.\u003c/li\u003e\n \u003cli\u003eNandhra SS, Littlewood SJ, Houghton N, Luther F, Prabhu J, Munyombwe T, et al. Do we need primer for orthodontic bonding? A randomized controlled trial. Eur J Orthod. 2015;37(2):147-55.\u003c/li\u003e\n \u003cli\u003eZhou Y, Wu S, Ma Y, Zhang H, Zeng X, Wu F, et al. Recent advances in organic/composite phase change materials for energy storage. ES Energy Envir. 2020;9(12):28-40.\u003c/li\u003e\n \u003cli\u003eBazargani F, Magnuson A, L\u0026ouml;thgren H, Kowalczyk A. Orthodontic bonding with and without primer: a randomized controlled trial. Eur J Orthod. 2016;38(5):503-7.\u003c/li\u003e\n \u003cli\u003eRai AK. Evaluation of bracket failure rate in orthodontic patients bonded with and without primer. Saudi J Dent Res. 2015;6(1):48-53.\u003c/li\u003e\n \u003cli\u003eRomano FL, Correr AB, Correr-Sobrinho L, Magnani MBBdA, Ruellas ACdO. Clinical evaluation of the failure rates of metallic brackets. J Appl Oral Sci. 2012;20(2):228-34.\u003c/li\u003e\n \u003cli\u003eBarbosa IV, de Miranda Ladewig V, Almeida-Pedrin RR, Cardoso MA, Junior JFS, Conti ACdCF. The association between patient\u0026rsquo;s compliance and age with the bonding failure of orthodontic brackets: a cross-sectional study. Prog Orthod. 2018;19(1):1-5.\u003c/li\u003e\n \u003cli\u003eJacobsen N, Aasenden R, Hensten-Pettersen A. Occupational health complaints and adverse patient reactions as perceived by personnel in public dentistry. Comm Dent Oral Epidemiol. 1991;19(3):155-9.\u003c/li\u003e\n \u003cli\u003eOzer M, Bayram M, Dincyurek C, Tokalak F. Clinical bond failure rates of adhesive precoated self-ligating brackets using a self-etching primer. Angle Orthod. 2014;84(1):155-60.\u003c/li\u003e\n \u003cli\u003eRajamuthu T, Rajagopalan A, Venkatachalapathy A, Krishnan P, Munusamy N, Asokan U. Orthodontic bracket failure rate after bonding with and without primer\u0026ndash;a systematic review and meta-analysis. Int Orthod. 2025;23(1):100934.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Bracket failure, Bonding, Failure rate, Orthodontic bracket, Primer","lastPublishedDoi":"10.21203/rs.3.rs-6533854/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6533854/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo compare the bracket debonding with and without primer in orthodontic patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterial and Methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis split-mouth randomized controlled trial was conducted on 42 participants. Diagonal quadrants were randomly assigned to either the primer (control) or non-primer (experimental) group. Allocation was concealed in opaque envelopes and revealed at the time of intervention. Both genders, aged 12–30 years, and visiting for the management of malocclusion were included. Patients with dental anomalies, caries, or restorations were excluded. The direct bonding technique was used for the placement of conventional metallic brackets. Participants were followed up for three months, with monthly visits, and bracket failure within each group was recorded. Logistic regression was used to calculate odds, with P ≤ 0.05 considered the level of significance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMean age was 17.41 ± 3.533 years with 45.2% males. Between the two groups, bracket failure rate at first (P = 0.3), second (P = 0.4) and third month (P \u0026gt; 0.99) was differed statistically. The failure rates in the primer and non-primer groups (4.31% vs 5.9%) were similar (OR = 1.386; 95% CI = 0.98–3.34; P = 0.298). However, the failure rate was significantly higher in the non-primer group for males (P = 0.005) and younger age groups (P = 0.016).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe use of primer may lead to retention of brackets in male patients and younger ages.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration \u003c/strong\u003eThis trial was not registered with any registry\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegistration\u003c/strong\u003e: This study was not registered\u003c/p\u003e","manuscriptTitle":"Brackets Detachment Without Primer Among Orthodontic Patients: A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-13 12:12:57","doi":"10.21203/rs.3.rs-6533854/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a6689e5a-d5b4-429d-8749-124e57d3bc9b","owner":[],"postedDate":"May 13th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-19T00:38:27+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-13 12:12:57","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6533854","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6533854","identity":"rs-6533854","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}