Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study

Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study | 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 Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study La-ongthong Vajrabhaya, Supranee Benjasupattananan, Kraisorn Sappayatosok, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4374624/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 Background While professional dental treatments are mandatory for advance periodontitis, maintaining proper oral hygiene can significantly contribute to preventing disease progression. Some herbal toothpastes and natural plant components may have some beneficial properties. Aloe vera is a medicinal plant with active ingredients that show antioxidant and anti-inflammatory effects. A toothpaste containing salt and Aloe vera may have adjunctive influence to non-surgical periodontal treatment. Aim This randomized parallel-group comparison study aimed to investigate the efficacy of an Aloe vera toothpaste (test group) compared to a Sodium bicarbonate toothpaste (control group) and a base toothpaste (benchmark group), with respect to outcomes of periodontitis treatment. Methods Fifty-four periodontitis patients were arbitrarily allotted into three groups. All subjects received mechanical instrumentation and instruction on oral hygiene using a toothbrush with these toothpastes and dental floss for a whole period of the study. The participants were evaluated at baseline (T0), week 4 (T1), and week 12 (T2) after complete full mouth scaling and root planing. During the visits, plaque score (PS), bleeding on probing (BOP), probing depth (PD) and clinical attachment level (CAL) were assessed and analyzed. Results The comparison groups had similar mean PS and BOP at baseline. At T1 and T2, both scores were reduced, however there was no statistically significant difference among the three groups for PS. A significant reduction in BOP score among the groups was observed ( p < 0.01) at T1. The PD in all groups were reduced significantly after non-surgical periodontal treatment. The CAL reduction was superior in the test group compared to the benchmark and the control group. In addition, there was no significant difference in the mean CAL among time points in the both benchmark and control groups. Conclusions Aloe vera toothpaste significantly decreased gingival bleeding, probing depth, and clinical attachment level in periodontitis patients during active periodontal treatment. Aloe vera Herbal product Toothpaste Periodontitis Periodontal treatment Background Periodontitis is a multi-factorial disease which affects a major part of world population. Key periodontal pathogens in supra- and subgingival dental biofilm and periodontal tissues interact with host immune response via innate and adaptive immunity. This results in destruction of connective tissue and alveolar bone and might end to tooth loss. [ 1 , 2 ] To arrest progressive attachment loss, both systemic and local risk factors associated with periodontitis have to be controlled. The removal of dental plaque and deposits by scaling and root planing (SRP) during the active periodontal treatment is imperative. [ 3 ] Additionally, the importance of oral hygiene care in the strict supportive periodontal treatment showed long-term stable periodontal status. [ 4 , 5 ] Routine mechanical tooth cleaning by toothbrushing alongside toothpaste is an effective method to reduce the pathogenic microbial load. To achieve this goal, toothpaste containing antibacterial and chemical agents, i.e. chlorhexidine, triclosan, metal salts, have been tested. [ 6 ] Presently, the awareness of the minimal toxicity and less harmful effects of herbal toothpastes has enlarged. Aloe vera (A. vera) is a medicinal plant that is commonly used to treat acute or chronic wounds. It is non-toxic substance and could significantly intensify fibroblast cell migration. [ 7 ] Additionally, the polysaccharides in A. vera gel lessened the bacterial load by promoting phagocytosis to eradicate the microbes. [ 8 ] A toothpaste containing A. vera demonstrated antimicrobial property on oral microorganisms, such as Streptococcus mutans and Candida albicans. [ 9 , 10 ] Moreover, a significant reduction in plaque accumulation from a mouth rinse containing A. vera was also observed. [ 11 ] The A. vera extract treatment has also resulted in a significant reduction of glutathione, superoxide dismutase, catalase, glutathione peroxidase, and glutathione S-transferase in the liver and kidney of diabetic rats, showing the antioxidant property of A. vera gel extract. [ 12 ] Recently, the herbal toothpaste containing A. vera and other herbal products used in the study was analyzed in laboratory experiment. It significantly increased gingival fibroblast cell migration and showed greater Porphyromonas gingivalis biofilm inhibition. [ 13 ] The toothpaste with antibacterial and enhancing healing properties could be alternative option for oral care that might foster oral health benefits during periodontal disease treatment. The objective of the study was to evaluate the effect of an herbal toothpaste during active periodontal treatment in untreated periodontitis patients. Materials and methods Study design and population The protocol for the human experiment was approved by the Ethical Committee of the Research Institute of Rangsit University (Project number RSUERB2020-011). This study protocol was approved by Thai Clinical Trials Registry on 16/5/2024 https://www.thaiclinicaltrials.org/show/TCTR20240516001 (the Clinical trial registration number TCTR20240516001). The study was carried out at the College of Dental Medicine, Rangsit University, Pathumthani, Thailand. The subjects were required to have at least 4 permanent teeth with periodontal pocket depth greater than 4 mm along with radiographic alveolar bone destruction. Besides, the subjects had to (1) have full mouth plaque score > 40%; (2) exhibit bleeding on probing > 30%; (3) be in the age range of 20–70 years; (4) provide informed consent. Exclusion criteria were the participants who had (1) been diagnosed as dental plaque induced gingivitis or non-plaque induced gingival lesions; (2) nonsurgical periodontal treatment in the preceding 12 months; (3) orthodontic treatment within 12 weeks; (4) periodontal surgery in the preceding 12 weeks; (5) ongoing treatment with antimicrobials and/or anti-inflammatory medication; (6) been pregnancy or lactation; (7) been smoking or alcohol abuse; (8) a history of an allergic reaction to the toothpastes. The informed consent was obtained from all subjects and/or their legal guardian(s). Intervention The study was a double-blinded randomized parallel-group comparison between the following three toothpastes: (1) herbal toothpaste containing the following active ingredients: A. vera , sodium chloride, mangosteen peel, whole Hydrocotyle plant, Clinacanthus nutans , extracts of orange jessamine leaf and toothbrush tree as displayed in Table 1 (Twin Lotus Co., Ltd, Bangkok, Thailand) (test group) (2) Sodium bicarbonate toothpaste (Parodontax®, Glaxo-SmithKline (Thailand), Ltd, Bangkok, Thailand) (control group) (3) Base toothpaste containing sorbitol, glycerin, calcium carbonate, and sodium lauryl sulfide (benchmark group). Table 1 Full scientific species of active ingredients in herbal toothpaste Active ingredient Full scientific species Aloe vera Aloe vera (L.) Burm. f. Clinacanthus nutans Clinacanthus nutans (Burm.f.) Lindau. Orange Jessamine leaf Murraya Exotica L. Hydrocotyle Centella asiatica (L.) Urb. Toothbrush tree Streblus asper Lour. Mangosteen peel Garcinia mangostana Linn. The subjects were arbitrarily allotted into one of three groups with the technique of simple randomization. All subjects received a nonsurgical periodontal treatment and oral hygiene instruction by using a soft-bristle toothbrush (Colgate®) with one of the aforementioned toothpastes at least 4 minutes and dental floss (Colgate®) twice daily for an entire period of study. All participants were evaluated at baseline (before the treatment); T0, 4 weeks after complete full mouth SRP; T1, and 12 weeks after SRP (end of the follow-up); T2. At the baseline and follow-up examinations, the following parameters were studied; Plaque score (PS): All teeth were stained with an erythrosine dye disclosing agent. The presence or absence of continuous biofilm at the cervical 1/3 of the facial, lingual, and proximal surfaces of each tooth was determined. The percentage of tooth surfaces with dental biofilm was calculated in each participant. [ 4 ] Bleeding on probing (BOP): The presence or absence of bleeding in six gingival units around each tooth (mesio-facial, midfacial, disto-facial, disto-lingual, midlingual, and mesio-lingual) was assessed following probing. The percentage of inflamed gingival units in relation to the total number of gingival units present was determined. Probing depth (PD) and Clinical attachment level (CAL): The Williams probe was used to measure PD (the distance from the gingival margin to the apical portion of the gingival sulcus) (mm) and CAL (the distance from cementoenamel junction to the apical portion of the gingival sulcus) (mm) in six units around each tooth. The means of full mouth PD and CAL were calculated. Statistical analysis The Kruskal–Wallis test was used to compare the means after using different toothpaste among the three comparison groups. The Bonferroni correction for multiple test was utilized to determine the differences between the means within the group at different visits for PS and BOP. The Friedman test was carried out to determine the differences between the means within the group at different visits for PD and CAL. The significance level was set at p < 0.05. Data analysis was achieved using Statistical Package for the Social Sciences version 18.0 for Windows (SPSS, Inc., Chicago, IL). Results A total of 54 qualified subjects agreed to join and were thus randomized (22 in the test group; 13 in the control group; 19 in the benchmark group). The age range of participants was 34–70 years, and the majority were male (63%). There was no report of adverse side effect or allergic reaction from using all toothpastes. The mean of full mouth PS, BOP, PD, and CAL at different time point are shown in Tables 2 and 3 which were not different across the groups at baseline. The comparison groups had similar mean PS and BOP at baseline ( p > 0.05). At week 4 and 12, both scores were reduced. There was no statistically significant difference among the three groups for PS. However, there was a significant reduction in BOP score ( p < 0.01) at week 4. The control group showed lowest mean full mouth BOP (13.83%) compared to test and benchmark group; 17.52% and 21.03% respectively. Moreover, there was no a statistically significant difference in BOP among the groups at the end of the study ( p > 0.05). (Table 2 ). The means of PD and CAL among the three comparison groups are shown in Table 3 . There was no overall difference of PD and CAL among groups at the beginning of the study. The PD in all groups were reduced significantly after nonsurgical periodontal treatment. In the test group, the PD decreased from 3.10 mm at baseline to 2.67 mm in week 4 and then to 2.63 mm in week 12. The reduction pattern was similar to that of the control group, in which the PD decreased from 3.02 mm at baseline to 2.44 mm in week 4 and 2.52 mm at the end of the study. At week 4 and week 12, there also was a statistically significant PD reduction for the benchmark group ( p ≤ 0.001). The changes in CAL in all groups at different time point are shown in Table 3 . The CAL were similar among the groups at baseline. Only the test group, the mean CAL significantly diminished from 2.71 mm at baseline to 2.30 mm at week 4 and 2.43 mm at week 12 ( p < 0.05). A reduction was also observed in the benchmark and control group, in contrast, this change was not statistically significance, from 2.63 and 2.71 mm to 2.34 and 2.62 mm respectively at the end of study. The Kruskal–Wallis test revealed that CAL reduction was superior in the test group compared to the benchmark and control group. In addition, there was no difference in the mean CAL between time point in the both benchmark and control groups. Discussion Periodontitis is a highly prevalent disease and prevention of occurrence or recurrence is dependent on patient’s plaque control. The ultimate goal of periodontitis treatment is to arrest progressive attachment loss, reduce pocket depths and control both systemic and local risk factors associated with periodontal diseases. Mechanical tooth cleaning is mainly influenced by the amenability and dexterity of the individuals and by the design features of oral hygiene aids. The maintenance of an effective level of plaque control is clearly difficult using conventional mechanical procedure and toothpaste and yet, from a therapeutic point-of-view. We assessed whether herbal toothpaste improved clinical gingival inflammation and periodontal parameters. The present study mainly focused on the effect of an herbal toothpaste during phase 1 periodontal treatment. We found that the herbal toothpaste containing A. vera reduced gingival inflammation, PD, and CAL in untreated periodontitis patients. The recent systematic review showed that the herbal toothpaste had superior effect over non-herbal toothpaste in dental biofilm reduction during a short term. [ 14 ]. On the contrary, our study did not show the difference of plaque reduction among the three groups after short and long term observations. The significant plaque reduction among groups might be strongly influenced by the individualized oral hygiene instruction which was chairside demonstrated by the operator. Interestingly, there was an overall substantial significant difference in gingival inflammation reduction at week 4 among the study groups. However, at the end of follow up, there was no a statistically significant difference in BOP among the groups even though the test group showed lowest mean full mouth BOP (17.85%) compared to the control and the benchmark group. The longer follow-up time may be required to evaluate long term outcomes. This is consistent with the preexisting literature which claimed that the herbal toothpaste did not reduce gingival inflammation for both short-term (4-week follow-up) and long-term (12-week follow-up) effects when compared to non-herbal toothpaste [ 14 ]. Additionally, there are some literatures which the results presented that the A. vera toothpaste was able to essentially reduce gingival index in the treatment of gingivitis. No side effects were observed due to the use of this herbal toothpaste. [ 10 , 15 ] Another result of the present study is that the PD in all groups were reduced significantly in the same pattern after scaling and root planing. Then probing depth reduction in the test and control groups did not show a difference compared to that in the benchmark group. Interestingly, the mean CAL in the test group diminished from 2.71 mm to 2.43 mm at week 12. A reduction was also observed in the benchmark and control group, however, this change was not statistically significance. The CAL reduction efficacy at the end of the study was utmost in the test group compared to the benchmark and control group. For the past two decades, herbal-related research has remarkable affected to oral health care especially oral lesion, periodontal and peri-implant disease treatment. Local delivered application predominates in dental industry, such as toothpastes, mouth rinses, varnishes, and gels have been the most commonly examined in numerous pharmaceutical forms [ 16 , 17 ]. Most of the herbal toothpastes show antiplaque and anti-inflammatory effects. [ 18 , 19 , 20 ] There are a limited number of studies regarding the efficacy of the herbal toothpaste as an adjunctive to periodontal treatment. To the best of our knowledge, this is the first study to assess the efficacy of A. vera toothpaste as an adjunctive method in periodontitis treatment. The herbal toothpaste containing A. vera that was used in the present study has been studied in vitro recently. This formulation significantly increased human gingival fibroblast cell migration which could have a positive effect to periodontal wound healing and regeneration. Furthermore, it demonstrated greater Porphyromonas gingivalis biofilm inhibition compared with the 0.12% chlorhexidine digluconate solution group. [ 13 ] The results in this study indicate that the use of the herbal toothpaste revealed superior efficiency compared with regular toothpastes in treating periodontitis. A toothpaste which could enhance wound healing is an alternative option for oral care that would provide oral health benefits for non-surgical periodontal treatment. However, the long-term effect of the A. Vera toothpaste should also be investigated. Another study limitation is the sample size. Since the data in each group were not normally distributed, further research should employ both greater sample size and a lengthier follow-up period. Conclusion This study documented that A. vera toothpaste significantly decreased gingival inflammation, PD, and CAL in periodontitis patients during non-surgical treatment. Abbreviations A.vera : Aloe vera ; PS: Plaque score; BOP: Bleeding on probing; PD: Probing depth; CAL: Clinical attachment level; SRP: Scaling and root planing Declarations Acknowledgements Not applicable. Author’s contributions LV and PS conducted the entire study. PS was the corresponding author. SB, KS, and VD were responsible for data collection. SK was responsible for data analysis. All authors had read and approved the final manuscript. Funding This research was funded by the National Science and Technology Development Agency under the Ministry of Science and Technology, Thailand. Availability of data and materials All data generated or analyzed during this study were included in this article. Ethics approval and consent to participate The protocol for the human experiment was approved by the Ethical Committee of the Research Institute of Rangsit University. The informed consent was obtained from all subjects and/or their legal guardian(s). Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. Author details 1 College of Dental Medicine, Rangsit University, Pathumthani 12000, Thailand 2 Research Office, Faculty of Dentistry, Mahidol University, Bangkok 10400, Thailand References Page RC. The etiology and pathogenesis of periodontitis. Compend Contin Educ Dent. 2002;23(Suppl. 5):11-4. Kornman KS, Lo ̈e H. The role of local factors in the etiology of periodontal diseases. Periodontol. 2000 1993;2:83-97. Cobb CM. Non-surgical pocket therapy: Mechanical. Ann Periodontol. 1996;1:443-90. Axelsson P, Lindhe J. The significance of maintenance care in the treatment of periodontal disease. J Clin Periodontol. 1981;8:281–94. Arweiler NB, Auschill TM, Sculean A. Patient self-care of periodontal pocket infections. Periodontol. 2000 2018;76:164-179. Davies RM. Toothpaste in the control of plaque/gingivitis and periodontitis. Periodontol. 2000 2008;48:23-30. Atiba A, Ueno H, Uzuka Y. The effect of aloe vera oral administration on cutaneous wound healing in type 2 diabetic rats. J Vet Meol Sci. 2011;73:583–9. Pugh N, Ross SA, ElSohly MA, Pasco DS. Characterization of Aloeride, a new high‐molecular‐weight polysaccharide from Aloe vera with potent immunostimulatory activity. J Agric food Chem 2001;49:1030–4. Lee SS, Zhang WLY. The antimicrobial potential of natural herbal den‐ trifices. Results of an in vitro diffusion method study. J Am Dent Assoc. 2004;135:1133–41. Khatri SG, Samuel SR, Acharya S, Patil ST. Antiplaque, Antifungal Effectiveness of Aloevera Among Intellectually Disabled Adolescents: Pilot Study. Pediatr Dent. 2017;39:434-38. Villalobos OJ, Salazar CR, Sánchez GR. Effect of a compound mouthwash Aloe vera in plaque and gingival inflammation. Acta Odontol Venez. 2001;39:16–24. Rajasekaran S, Sivagnanam K, Subramanian S. Anti- oxidant effect of Aloe vera gel extract in streptozoto- cin-induced diabetes in rats. Pharmacol Rep. 2005;57:90-96. Vajrabhaya LO, Korsuwannawong S, Ruangsawasdi N, Phruksaniyom C, Srichan R. The efficiency of natural wound healing and bacterial biofilm inhibition of Aloe vera and Sodium Chloride toothpaste preparation. BMC Complement Med Ther. 2022;22:66. doi: 10.1186/s12906-022-03548-7. Janakiram C, Venkitachalam R, Fontelo P, Iafolla TJ, Dye BA. Effectiveness of herbal oral care products in reducing dental plaque & gingivitis – a systematic review and meta-analysis. BMC Complement Med Ther. 2020;20:43. Sayar F, Farahmand AH, Rezazadeh M. Clinical Efficacy of Aloe Vera Toothpaste on Periodontal Parameters of Patients with Gingivitis-A Randomized, Controlled, Single-masked Clinical Trial. J Contemp Dent Pract. 2021;22:242-7. Freires IA, Rosalen PL. How natural product research has contributed to oral care product development? A critical view. Pharm Res. 2016;33:1311–7. DOI: 10.1007/s11095-016-1905-5. Al-Maweri SA, Nassani MZ, Alaizari N, Kalakonda B, Al-Shamiri HM, Alhajj MN, Al-Soneidar WA, Alahmary AW. Efficacy of aloe vera mouthwash versus chlorhexidine on plaque and gingivitis: A systematic review. Int J Dent Hyg. 2020;18:44-51. Mullally BH, James JA, Coulter WA, et al. The efficacy of a herbal-based toothpaste on the control of plaque and gingivitis. J Clin Periodontol. 1995;22:686–9. DOI: 10.1111/j.1600-051X.1995.tb00827.x. Tatikonda A, Debnath S, Chauhan VS, et al. Effects of herbal and non- herbal toothpastes on plaque and gingivitis: a clinical comparative study. J Int Soc Prev Community Dent. 2014;4(Suppl 2):S126–S129. DOI: 10.4103/2231-0762.146220. Azaripour A, Mahmoodi B, Habibi E, et al. Effectiveness of a miswak extract-containing toothpaste on gingival inflammation: a randomized clinical trial. Int J Dent Hyg. 2017;15:195–202. DOI: 10.1111/idh.12195. Table 2 and 3 Table 2 and 3 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table2and3.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4374624","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":308822417,"identity":"f64d3b79-516c-4330-bc83-2817494a3fc1","order_by":0,"name":"La-ongthong Vajrabhaya","email":"","orcid":"","institution":"Rangsit University","correspondingAuthor":false,"prefix":"","firstName":"La-ongthong","middleName":"","lastName":"Vajrabhaya","suffix":""},{"id":308822418,"identity":"c142edb3-473b-4580-929d-b0c136e5aadd","order_by":1,"name":"Supranee Benjasupattananan","email":"","orcid":"","institution":"Rangsit University","correspondingAuthor":false,"prefix":"","firstName":"Supranee","middleName":"","lastName":"Benjasupattananan","suffix":""},{"id":308822419,"identity":"3424a825-64ba-4ec9-9605-f67a5669b715","order_by":2,"name":"Kraisorn Sappayatosok","email":"","orcid":"","institution":"Rangsit University","correspondingAuthor":false,"prefix":"","firstName":"Kraisorn","middleName":"","lastName":"Sappayatosok","suffix":""},{"id":308822420,"identity":"87ca554e-63ec-4ad3-87b0-a210b63d8c60","order_by":3,"name":"Vittawin Dechosilpa","email":"","orcid":"","institution":"Rangsit University","correspondingAuthor":false,"prefix":"","firstName":"Vittawin","middleName":"","lastName":"Dechosilpa","suffix":""},{"id":308822421,"identity":"ff091b2b-8c92-46df-97ec-dbe77948d24e","order_by":4,"name":"Suwanna Korsuwannawong","email":"","orcid":"","institution":"Mahidol University","correspondingAuthor":false,"prefix":"","firstName":"Suwanna","middleName":"","lastName":"Korsuwannawong","suffix":""},{"id":308822422,"identity":"a17d5e94-b657-4ae7-909a-cf4100e1849b","order_by":5,"name":"Papatpong Sirikururat","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA5klEQVRIiWNgGAWjYJADxgcwFjNBtQegCg1gepuJ1cImQZQWc/azBz9/3GGTJ+/A/qy64s9hBv72A+yPC/BosezJS5Y4eCat2PAAj9nNs22HGSTOJDA2z8CjxeBAjoHEwbbDiRsbeNhuNjYcZmC4AXQYDz4t598Y/4BoYX9W2AB0mDxBLTdyzMC2zGdgMGNsYDsMFCGgxXLGuzSLs2fSEjcw8xhLNral8xieSWycjU+LOX/u4RuVO2wS57e3P/zY8MdaTu744QOf8TqMASjL2ABkHIYIQLnEaJHHr24UjIJRMApGMgAA/ItRXUQPMYEAAAAASUVORK5CYII=","orcid":"","institution":"Rangsit University","correspondingAuthor":true,"prefix":"","firstName":"Papatpong","middleName":"","lastName":"Sirikururat","suffix":""}],"badges":[],"createdAt":"2024-05-06 06:53:21","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4374624/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4374624/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":63900410,"identity":"bc32a9ab-08fc-47e9-8834-a6a7ea7071c4","added_by":"auto","created_at":"2024-09-03 14:17:28","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":361541,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4374624/v1/0b5099a7-c99a-4a40-acaa-100ac1fe52f5.pdf"},{"id":57480685,"identity":"65fb385b-5f0f-457e-9d84-45e9a221e980","added_by":"auto","created_at":"2024-05-31 09:01:21","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":63124,"visible":true,"origin":"","legend":"","description":"","filename":"Table2and3.docx","url":"https://assets-eu.researchsquare.com/files/rs-4374624/v1/a58968eefb4d5b9c4410d1c7.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study","fulltext":[{"header":"Background","content":"\u003cp\u003ePeriodontitis is a multi-factorial disease which affects a major part of world population. Key periodontal pathogens in supra- and subgingival dental biofilm and periodontal tissues interact with host immune response via innate and adaptive immunity. This results in destruction of connective tissue and alveolar bone and might end to tooth loss. [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] To arrest progressive attachment loss, both systemic and local risk factors associated with periodontitis have to be controlled. The removal of dental plaque and deposits by scaling and root planing (SRP) during the active periodontal treatment is imperative. [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] Additionally, the importance of oral hygiene care in the strict supportive periodontal treatment showed long-term stable periodontal status. [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eRoutine mechanical tooth cleaning by toothbrushing alongside toothpaste is an effective method to reduce the pathogenic microbial load. To achieve this goal, toothpaste containing antibacterial and chemical agents, i.e. chlorhexidine, triclosan, metal salts, have been tested. [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] Presently, the awareness of the minimal toxicity and less harmful effects of herbal toothpastes has enlarged. \u003cem\u003eAloe vera (A. vera)\u003c/em\u003e is a medicinal plant that is commonly used to treat acute or chronic wounds. It is non-toxic substance and could significantly intensify fibroblast cell migration. [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] Additionally, the polysaccharides in \u003cem\u003eA. vera\u003c/em\u003e gel lessened the bacterial load by promoting phagocytosis to eradicate the microbes. [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] A toothpaste containing \u003cem\u003eA. vera\u003c/em\u003e demonstrated antimicrobial property on oral microorganisms, such as \u003cem\u003eStreptococcus mutans\u003c/em\u003e and \u003cem\u003eCandida albicans.\u003c/em\u003e [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] Moreover, a significant reduction in plaque accumulation from a mouth rinse containing \u003cem\u003eA. vera\u003c/em\u003e was also observed. [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] The \u003cem\u003eA. vera\u003c/em\u003e extract treatment has also resulted in a significant reduction of glutathione, superoxide dismutase, catalase, glutathione peroxidase, and glutathione S-transferase in the liver and kidney of diabetic rats, showing the antioxidant property of \u003cem\u003eA. vera\u003c/em\u003e gel extract. [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] Recently, the herbal toothpaste containing \u003cem\u003eA. vera\u003c/em\u003e and other herbal products used in the study was analyzed in laboratory experiment. It significantly increased gingival fibroblast cell migration and showed greater \u003cem\u003ePorphyromonas gingivalis\u003c/em\u003e biofilm inhibition. [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] The toothpaste with antibacterial and enhancing healing properties could be alternative option for oral care that might foster oral health benefits during periodontal disease treatment.\u003c/p\u003e \u003cp\u003eThe objective of the study was to evaluate the effect of an herbal toothpaste during active periodontal treatment in untreated periodontitis patients.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cp\u003eStudy design and population\u003c/p\u003e \u003cp\u003e The protocol for the human experiment was approved by the Ethical Committee of the Research Institute of Rangsit University (Project number RSUERB2020-011). This study protocol was approved by Thai Clinical Trials Registry on 16/5/2024 \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.thaiclinicaltrials.org/show/TCTR20240516001\u003c/span\u003e\u003cspan address=\"https://www.thaiclinicaltrials.org/show/TCTR20240516001\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e (the Clinical trial registration number TCTR20240516001). The study was carried out at the College of Dental Medicine, Rangsit University, Pathumthani, Thailand. The subjects were required to have at least 4 permanent teeth with periodontal pocket depth greater than 4 mm along with radiographic alveolar bone destruction. Besides, the subjects had to (1) have full mouth plaque score\u0026thinsp;\u0026gt;\u0026thinsp;40%; (2) exhibit bleeding on probing\u0026thinsp;\u0026gt;\u0026thinsp;30%; (3) be in the age range of 20\u0026ndash;70 years; (4) provide informed consent. Exclusion criteria were the participants who had (1) been diagnosed as dental plaque induced gingivitis or non-plaque induced gingival lesions; (2) nonsurgical periodontal treatment in the preceding 12 months; (3) orthodontic treatment within 12 weeks; (4) periodontal surgery in the preceding 12 weeks; (5) ongoing treatment with antimicrobials and/or anti-inflammatory medication; (6) been pregnancy or lactation; (7) been smoking or alcohol abuse; (8) a history of an allergic reaction to the toothpastes. The informed consent was obtained from all subjects and/or their legal guardian(s).\u003c/p\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003eThe study was a double-blinded randomized parallel-group comparison between the following three toothpastes: (1) herbal toothpaste containing the following active ingredients: \u003cem\u003eA. vera\u003c/em\u003e, sodium chloride, mangosteen peel, whole \u003cem\u003eHydrocotyle\u003c/em\u003e plant, \u003cem\u003eClinacanthus nutans\u003c/em\u003e, extracts of orange jessamine leaf and toothbrush tree as displayed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e (Twin Lotus Co., Ltd, Bangkok, Thailand) (test group) (2) Sodium bicarbonate toothpaste (Parodontax\u0026reg;, Glaxo-SmithKline (Thailand), Ltd, Bangkok, Thailand) (control group) (3) Base toothpaste containing sorbitol, glycerin, calcium carbonate, and sodium lauryl sulfide (benchmark group).\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\u003eFull scientific species of active ingredients in herbal toothpaste\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eActive ingredient\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFull scientific species\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eAloe vera\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eAloe vera\u003c/em\u003e (L.) Burm. f.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eClinacanthus nutans\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eClinacanthus nutans\u003c/em\u003e (Burm.f.) Lindau.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOrange Jessamine leaf\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eMurraya Exotica\u003c/em\u003e L.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eHydrocotyle\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eCentella asiatica\u003c/em\u003e (L.) Urb.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eToothbrush tree\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eStreblus asper\u003c/em\u003e Lour.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMangosteen peel\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eGarcinia mangostana\u003c/em\u003e Linn.\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\u003eThe subjects were arbitrarily allotted into one of three groups with the technique of simple randomization. All subjects received a nonsurgical periodontal treatment and oral hygiene instruction by using a soft-bristle toothbrush (Colgate\u0026reg;) with one of the aforementioned toothpastes at least 4 minutes and dental floss (Colgate\u0026reg;) twice daily for an entire period of study. All participants were evaluated at baseline (before the treatment); T0, 4 weeks after complete full mouth SRP; T1, and 12 weeks after SRP (end of the follow-up); T2. At the baseline and follow-up examinations, the following parameters were studied;\u003c/p\u003e \u003cp\u003ePlaque score (PS):\u003c/p\u003e \u003cp\u003eAll teeth were stained with an erythrosine dye disclosing agent. The presence or absence of continuous biofilm at the cervical 1/3 of the facial, lingual, and proximal surfaces of each tooth was determined. The percentage of tooth surfaces with dental biofilm was calculated in each participant. [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eBleeding on probing (BOP):\u003c/p\u003e \u003cp\u003eThe presence or absence of bleeding in six gingival units around each tooth (mesio-facial, midfacial, disto-facial, disto-lingual, midlingual, and mesio-lingual) was assessed following probing. The percentage of inflamed gingival units in relation to the total number of gingival units present was determined.\u003c/p\u003e \u003cp\u003eProbing depth (PD) and Clinical attachment level (CAL):\u003c/p\u003e \u003cp\u003eThe Williams probe was used to measure PD (the distance from the gingival margin to the apical portion of the gingival sulcus) (mm) and CAL (the distance from cementoenamel junction to the apical portion of the gingival sulcus) (mm) in six units around each tooth. The means of full mouth PD and CAL were calculated.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe Kruskal\u0026ndash;Wallis test was used to compare the means after using different toothpaste among the three comparison groups. The Bonferroni correction for multiple test was utilized to determine the differences between the means within the group at different visits for PS and BOP. The Friedman test was carried out to determine the differences between the means within the group at different visits for PD and CAL. The significance level was set at \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Data analysis was achieved using Statistical Package for the Social Sciences version 18.0 for Windows (SPSS, Inc., Chicago, IL).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 54 qualified subjects agreed to join and were thus randomized (22 in the test group; 13 in the control group; 19 in the benchmark group). The age range of participants was 34\u0026ndash;70 years, and the majority were male (63%). There was no report of adverse side effect or allergic reaction from using all toothpastes. The mean of full mouth PS, BOP, PD, and CAL at different time point are shown in Tables \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e and \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e which were not different across the groups at baseline.\u003c/p\u003e\n\u003cp\u003eThe comparison groups had similar mean PS and BOP at baseline (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). At week 4 and 12, both scores were reduced. There was no statistically significant difference among the three groups for PS. However, there was a significant reduction in BOP score (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01) at week 4. The control group showed lowest mean full mouth BOP (13.83%) compared to test and benchmark group; 17.52% and 21.03% respectively. Moreover, there was no a statistically significant difference in BOP among the groups at the end of the study (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe means of PD and CAL among the three comparison groups are shown in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e. There was no overall difference of PD and CAL among groups at the beginning of the study. The PD in all groups were reduced significantly after nonsurgical periodontal treatment. In the test group, the PD decreased from 3.10 mm at baseline to 2.67 mm in week 4 and then to 2.63 mm in week 12. The reduction pattern was similar to that of the control group, in which the PD decreased from 3.02 mm at baseline to 2.44 mm in week 4 and 2.52 mm at the end of the study. At week 4 and week 12, there also was a statistically significant PD reduction for the benchmark group (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e\u0026thinsp;0.001). The changes in CAL in all groups at different time point are shown in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e. The CAL were similar among the groups at baseline. Only the test group, the mean CAL significantly diminished from 2.71 mm at baseline to 2.30 mm at week 4 and 2.43 mm at week 12 (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). A reduction was also observed in the benchmark and control group, in contrast, this change was not statistically significance, from 2.63 and 2.71 mm to 2.34 and 2.62 mm respectively at the end of study. The Kruskal\u0026ndash;Wallis test revealed that CAL reduction was superior in the test group compared to the benchmark and control group. In addition, there was no difference in the mean CAL between time point in the both benchmark and control groups.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003ePeriodontitis is a highly prevalent disease and prevention of occurrence or recurrence is dependent on patient\u0026rsquo;s plaque control. The ultimate goal of periodontitis treatment is to arrest progressive attachment loss, reduce pocket depths and control both systemic and local risk factors associated with periodontal diseases. Mechanical tooth cleaning is mainly influenced by the amenability and dexterity of the individuals and by the design features of oral hygiene aids. The maintenance of an effective level of plaque control is clearly difficult using conventional mechanical procedure and toothpaste and yet, from a therapeutic point-of-view. We assessed whether herbal toothpaste improved clinical gingival inflammation and periodontal parameters. The present study mainly focused on the effect of an herbal toothpaste during phase 1 periodontal treatment. We found that the herbal toothpaste containing \u003cem\u003eA. vera\u003c/em\u003e reduced gingival inflammation, PD, and CAL in untreated periodontitis patients.\u003c/p\u003e \u003cp\u003eThe recent systematic review showed that the herbal toothpaste had superior effect over non-herbal toothpaste in dental biofilm reduction during a short term. [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. On the contrary, our study did not show the difference of plaque reduction among the three groups after short and long term observations. The significant plaque reduction among groups might be strongly influenced by the individualized oral hygiene instruction which was chairside demonstrated by the operator. Interestingly, there was an overall substantial significant difference in gingival inflammation reduction at week 4 among the study groups. However, at the end of follow up, there was no a statistically significant difference in BOP among the groups even though the test group showed lowest mean full mouth BOP (17.85%) compared to the control and the benchmark group. The longer follow-up time may be required to evaluate long term outcomes. This is consistent with the preexisting literature which claimed that the herbal toothpaste did not reduce gingival inflammation for both short-term (4-week follow-up) and long-term (12-week follow-up) effects when compared to non-herbal toothpaste [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Additionally, there are some literatures which the results presented that the \u003cem\u003eA. vera\u003c/em\u003e toothpaste was able to essentially reduce gingival index in the treatment of gingivitis. No side effects were observed due to the use of this herbal toothpaste. [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eAnother result of the present study is that the PD in all groups were reduced significantly in the same pattern after scaling and root planing. Then probing depth reduction in the test and control groups did not show a difference compared to that in the benchmark group. Interestingly, the mean CAL in the test group diminished from 2.71 mm to 2.43 mm at week 12. A reduction was also observed in the benchmark and control group, however, this change was not statistically significance. The CAL reduction efficacy at the end of the study was utmost in the test group compared to the benchmark and control group.\u003c/p\u003e \u003cp\u003eFor the past two decades, herbal-related research has remarkable affected to oral health care especially oral lesion, periodontal and peri-implant disease treatment. Local delivered application predominates in dental industry, such as toothpastes, mouth rinses, varnishes, and gels have been the most commonly examined in numerous pharmaceutical forms [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Most of the herbal toothpastes show antiplaque and anti-inflammatory effects. [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] There are a limited number of studies regarding the efficacy of the herbal toothpaste as an adjunctive to periodontal treatment. To the best of our knowledge, this is the first study to assess the efficacy of \u003cem\u003eA. vera\u003c/em\u003e toothpaste as an adjunctive method in periodontitis treatment. The herbal toothpaste containing \u003cem\u003eA. vera\u003c/em\u003e that was used in the present study has been studied in vitro recently. This formulation significantly increased human gingival fibroblast cell migration which could have a positive effect to periodontal wound healing and regeneration. Furthermore, it demonstrated greater \u003cem\u003ePorphyromonas gingivalis\u003c/em\u003e biofilm inhibition compared with the 0.12% chlorhexidine digluconate solution group. [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eThe results in this study indicate that the use of the herbal toothpaste revealed superior efficiency compared with regular toothpastes in treating periodontitis. A toothpaste which could enhance wound healing is an alternative option for oral care that would provide oral health benefits for non-surgical periodontal treatment. However, the long-term effect of the \u003cem\u003eA. Vera\u003c/em\u003e toothpaste should also be investigated. Another study limitation is the sample size. Since the data in each group were not normally distributed, further research should employ both greater sample size and a lengthier follow-up period.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study documented that \u003cem\u003eA. vera\u003c/em\u003e toothpaste significantly decreased gingival inflammation, PD, and CAL in periodontitis patients during non-surgical treatment.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cem\u003eA.vera\u003c/em\u003e: \u003cem\u003eAloe vera\u003c/em\u003e; PS: Plaque score; BOP: Bleeding on probing; PD: Probing depth; CAL: Clinical attachment level; SRP: Scaling and root planing\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eAuthor\u0026rsquo;s contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLV and PS conducted the entire study. PS was the corresponding author. SB, KS, and VD were responsible for data collection. SK was responsible for data analysis. All authors had read and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research was funded by the National Science and Technology Development Agency under the Ministry of Science and Technology, Thailand.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data generated or analyzed during this study were included in this article.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe protocol for the human\u0026nbsp;experiment\u0026nbsp;was approved by the Ethical Committee of the Research Institute of Rangsit University. The informed consent was obtained from all subjects and/or their legal guardian(s).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\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 competing interests.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eAuthor details\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003e College of Dental Medicine, Rangsit University, Pathumthani 12000, Thailand\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e2\u003c/sup\u003e Research Office, Faculty of Dentistry, Mahidol University, Bangkok 10400, Thailand\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003ePage RC. The etiology and pathogenesis of periodontitis. Compend Contin Educ Dent. 2002;23(Suppl. 5):11-4. \u003c/li\u003e\n\u003cli\u003eKornman KS, Lo ̈e H. The role of local factors in the etiology of periodontal diseases. Periodontol. 2000 1993;2:83-97. \u003c/li\u003e\n\u003cli\u003eCobb CM. Non-surgical pocket therapy: Mechanical. Ann Periodontol. 1996;1:443-90. \u003c/li\u003e\n\u003cli\u003eAxelsson P, Lindhe J. The significance of maintenance care in the treatment of periodontal disease. J Clin Periodontol. 1981;8:281\u0026ndash;94. \u003c/li\u003e\n\u003cli\u003eArweiler NB, Auschill TM, Sculean A. Patient self-care of periodontal pocket infections. Periodontol. 2000 2018;76:164-179.\u003c/li\u003e\n\u003cli\u003eDavies RM. Toothpaste in the control of plaque/gingivitis and periodontitis. Periodontol. 2000 2008;48:23-30.\u003c/li\u003e\n\u003cli\u003eAtiba A, Ueno H, Uzuka Y. The effect of \u003cem\u003ealoe vera \u003c/em\u003eoral administration on cutaneous wound healing in type 2 diabetic rats. J Vet Meol Sci. 2011;73:583\u0026ndash;9. \u003c/li\u003e\n\u003cli\u003ePugh N, Ross SA, ElSohly MA, Pasco DS. Characterization of Aloeride, a new high‐molecular‐weight polysaccharide from \u003cem\u003eAloe vera \u003c/em\u003ewith potent immunostimulatory activity. J Agric food Chem 2001;49:1030\u0026ndash;4. \u003c/li\u003e\n\u003cli\u003eLee SS, Zhang WLY. The antimicrobial potential of natural herbal den‐ trifices. Results of an in vitro diffusion method study. J Am Dent Assoc. 2004;135:1133\u0026ndash;41. \u003c/li\u003e\n\u003cli\u003eKhatri SG, Samuel SR, Acharya S, Patil ST. Antiplaque, Antifungal Effectiveness of Aloevera Among Intellectually Disabled Adolescents: Pilot Study. Pediatr Dent. 2017;39:434-38.\u003c/li\u003e\n\u003cli\u003eVillalobos OJ, Salazar CR, Sánchez GR. Effect of a compound mouthwash \u003cem\u003eAloe vera \u003c/em\u003ein plaque and gingival inflammation. Acta Odontol Venez. 2001;39:16\u0026ndash;24. \u003c/li\u003e\n\u003cli\u003eRajasekaran S, Sivagnanam K, Subramanian S. Anti- oxidant effect of Aloe vera gel extract in streptozoto- cin-induced diabetes in rats. Pharmacol Rep. 2005;57:90-96. \u003c/li\u003e\n\u003cli\u003eVajrabhaya LO, Korsuwannawong S, Ruangsawasdi N, Phruksaniyom C, Srichan R. The efficiency of natural wound healing and bacterial biofilm inhibition of \u003cem\u003eAloe vera \u003c/em\u003eand Sodium Chloride toothpaste preparation. BMC Complement Med Ther. 2022;22:66. doi: 10.1186/s12906-022-03548-7.\u003c/li\u003e\n\u003cli\u003eJanakiram C, Venkitachalam R, Fontelo P, Iafolla TJ, Dye BA. Effectiveness of herbal oral care products in reducing dental plaque \u0026amp; gingivitis \u0026ndash; a systematic review and meta-analysis. BMC Complement Med Ther. 2020;20:43. \u003c/li\u003e\n\u003cli\u003eSayar F, Farahmand AH, Rezazadeh M. Clinical Efficacy of Aloe Vera Toothpaste on Periodontal Parameters of Patients with Gingivitis-A Randomized, Controlled, Single-masked Clinical Trial. J Contemp Dent Pract. 2021;22:242-7.\u003c/li\u003e\n\u003cli\u003eFreires IA, Rosalen PL. How natural product research has contributed to oral care product development? A critical view. Pharm Res. 2016;33:1311\u0026ndash;7. DOI: 10.1007/s11095-016-1905-5. \u003c/li\u003e\n\u003cli\u003eAl-Maweri SA, Nassani MZ, Alaizari N, Kalakonda B, Al-Shamiri HM, Alhajj MN, Al-Soneidar WA, Alahmary AW. Efficacy of aloe vera mouthwash versus chlorhexidine on plaque and gingivitis: A systematic review. Int J Dent Hyg. 2020;18:44-51.\u003c/li\u003e\n\u003cli\u003eMullally BH, James JA, Coulter WA, et al. The efficacy of a herbal-based toothpaste on the control of plaque and gingivitis. J Clin Periodontol. 1995;22:686\u0026ndash;9. DOI: 10.1111/j.1600-051X.1995.tb00827.x. \u003c/li\u003e\n\u003cli\u003eTatikonda A, Debnath S, Chauhan VS, et al. Effects of herbal and non- herbal toothpastes on plaque and gingivitis: a clinical comparative study. J Int Soc Prev Community Dent. 2014;4(Suppl 2):S126\u0026ndash;S129. DOI: 10.4103/2231-0762.146220. \u003c/li\u003e\n\u003cli\u003eAzaripour A, Mahmoodi B, Habibi E, et al. Effectiveness of a miswak extract-containing toothpaste on gingival inflammation: a randomized clinical trial. Int J Dent Hyg. 2017;15:195\u0026ndash;202. DOI: 10.1111/idh.12195. \u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table 2 and 3","content":"\u003cp\u003eTable 2 and 3 are available in the Supplementary Files section.\u003c/p\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":"Aloe vera, Herbal product, Toothpaste, Periodontitis, Periodontal treatment","lastPublishedDoi":"10.21203/rs.3.rs-4374624/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4374624/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eWhile professional dental treatments are mandatory for advance periodontitis, maintaining proper oral hygiene can significantly contribute to preventing disease progression. Some herbal toothpastes and natural plant components may have some beneficial properties. \u003cem\u003eAloe vera\u003c/em\u003e is a medicinal plant with active ingredients that show antioxidant and anti-inflammatory effects. A toothpaste containing salt and \u003cem\u003eAloe vera\u003c/em\u003e may have adjunctive influence to non-surgical periodontal treatment.\u003c/p\u003e\u003ch2\u003eAim\u003c/h2\u003e \u003cp\u003eThis randomized parallel-group comparison study aimed to investigate the efficacy of an \u003cem\u003eAloe vera\u003c/em\u003e toothpaste (test group) compared to a Sodium bicarbonate toothpaste (control group) and a base toothpaste (benchmark group), with respect to outcomes of periodontitis treatment.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eFifty-four periodontitis patients were arbitrarily allotted into three groups. All subjects received mechanical instrumentation and instruction on oral hygiene using a toothbrush with these toothpastes and dental floss for a whole period of the study. The participants were evaluated at baseline (T0), week 4 (T1), and week 12 (T2) after complete full mouth scaling and root planing. During the visits, plaque score (PS), bleeding on probing (BOP), probing depth (PD) and clinical attachment level (CAL) were assessed and analyzed.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe comparison groups had similar mean PS and BOP at baseline. At T1 and T2, both scores were reduced, however there was no statistically significant difference among the three groups for PS. A significant reduction in BOP score among the groups was observed (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.01) at T1. The PD in all groups were reduced significantly after non-surgical periodontal treatment. The CAL reduction was superior in the test group compared to the benchmark and the control group. In addition, there was no significant difference in the mean CAL among time points in the both benchmark and control groups.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003e \u003cem\u003eAloe vera\u003c/em\u003e toothpaste significantly decreased gingival bleeding, probing depth, and clinical attachment level in periodontitis patients during active periodontal treatment.\u003c/p\u003e","manuscriptTitle":"Efficacy of Aloe vera toothpaste during active periodontal treatment: A clinical study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-31 09:01:16","doi":"10.21203/rs.3.rs-4374624/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":"08344d48-dffc-41d2-9f19-35c10cadad7f","owner":[],"postedDate":"May 31st, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-09-03T14:09:22+00:00","versionOfRecord":[],"versionCreatedAt":"2024-05-31 09:01:16","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4374624","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4374624","identity":"rs-4374624","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}