Effect of Non-surgical Periodontal Therapy on Risk of Adverse Pregnancy Outcomes: A Randomized Controlled Trial in Indian Population.

Effect of Non-surgical Periodontal Therapy on Risk of Adverse Pregnancy Outcomes: A Randomized Controlled Trial in Indian Population. | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 22 January 2026 V1 Latest version Share on Effect of Non-surgical Periodontal Therapy on Risk of Adverse Pregnancy Outcomes: A Randomized Controlled Trial in Indian Population. Authors : Aaron F. Gomes , Preeti Pandey , and Meru S 0000-0001-7936-4664 [email protected] Authors Info & Affiliations https://doi.org/10.22541/au.176905090.07457903/v1 119 views 56 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background: Periodontitis in pregnant women is associated with adverse pregnancy outcomes (APOs), including low birth-weight (LBW), preterm birth (PTB), preterm low birth-weight (PLBW), pre-eclampsia. Objective: To investigate the association between periodontal disease and APOs. Study Design and Sample: A three-arm parallel randomized controlled trial was conducted among 75 pregnant women. Materials and Methods: Participants were randomly assigned to three groups: control group (receiving oral hygiene instructions only); test group1 (receiving non-surgical periodontal therapy (NSPT) at 16–20 weeks of gestation); test group2 (receiving NSTP at 16–20 weeks and at 25–28 weeks of gestation). Obstetric outcomes were recorded after delivery. Periodontal parameters including Plaque Index, Gingival Index, bleeding on probing, probing pocket depth, clinical attachment level, number of teeth present, and periodontal case definitions were assessed at 16–20 weeks (t1), 21–24 weeks (t2), and 29–32 weeks (t3) of gestation. Statistical Analysis: ANOVA and paired t -tests were used for data analysis. Pearson’s Chi-square test evaluated the association between periodontal status and APOs, and Cramér’s V test assessed the strength of association. A p -value ≤0.05 was considered statistically significant. Results: Sixty participants completed the study. LBW and PTB incidence were significantly higher in the control group compared to test groups. Periodontal parameters were significantly worse in the control group at t2 and t3. There was significant association between periodontal status and PTD and LBW. Conclusion: NSPT during pregnancy, performed regularly, significantly reduced adverse pregnancy outcomes such as LBW, PTB, and PLBW. Funding: No external funding was received. SCIENTIFIC TITLE: Effect of Non-surgical Periodontal Therapy on Risk of Adverse Pregnancy Outcomes: A Randomized Controlled Trial in Indian Population. SHORT RUNNING TITLE: Non-surgical Periodontal Therapy during Pregnancy and Adverse Pregnancy Outcomes 1. Prof. Dr. Aaron F. Gomes M.D.S. Professor & Head, Department of Periodontology & Oral Implantology, Uttaranchal Dental & Medical Research Institute, Mazri Grant, Dehradun, Uttarakhand, India. 248140. 2. Dr. Preeti Pandey M.D. Medical Director and Head, Department of Obstetrics and Gynecology, Uttaranchal Hospital. Mazri Grant, Dehradun, Uttarakhand, India. 248140 3. Dr. Meru S M.D.S. Professor & Head, Department of Oral Medicine and Radiology Uttaranchal Dental & Medical Research Institute, Mazri Grant, Dehradun, Uttarakhand, India. 248140. ONE SENTENCE SUMMARY: Non-surgical periodontal therapy done at 16-20 weeks of gestation followed by repeat of non-surgical therapy at 25-28 weeks of gestation significantly reduced the incidence of Adverse Pregnancy Outcomes (APO’s) such as preterm birth, low birth weight preterm low birth weight, stillbirth and pre-eclampsia. KEYWORDS: Study Types: Triple arm Parallel Group Randomized Control Trial MeSH Terms: Adverse pregnancy outcomes Gingivitis Low Birth Weight Oral health Pre-eclampsia Pregnancy Preterm birth Preterm Low Birth Weight Periodontal Therapy Stillbirth ABSTRACT: Background: Periodontitis in pregnant women is associated with adverse pregnancy outcomes (APOs), including low birth-weight (LBW), preterm birth (PTB), preterm low birth-weight (PLBW), pre-eclampsia. Objective: To investigate the association between periodontal disease and APOs. Study Design and Sample: A three-arm parallel randomized controlled trial was conducted among 75 pregnant women. Materials and Methods: Participants were randomly assigned to three groups: control group (receiving oral hygiene instructions only); test group1 (receiving non-surgical periodontal therapy (NSPT) at 16–20 weeks of gestation); test group2 (receiving NSTP at 16–20 weeks and at 25–28 weeks of gestation). Obstetric outcomes were recorded after delivery. Periodontal parameters including Plaque Index, Gingival Index, bleeding on probing, probing pocket depth, clinical attachment level, number of teeth present, and periodontal case definitions were assessed at 16–20 weeks (t1), 21–24 weeks (t2), and 29–32 weeks (t3) of gestation. Statistical Analysis: ANOVA and paired t -tests were used for data analysis. Pearson’s Chi-square test evaluated the association between periodontal status and APOs, and Cramér’s V test assessed the strength of association. A p -value ≤0.05 was considered statistically significant. Results: Sixty participants completed the study. LBW and PTB incidence were significantly higher in the control group compared to test groups. Periodontal parameters were significantly worse in the control group at t2 and t3. There was significant association between periodontal status and PTD and LBW. Conclusion: NSPT during pregnancy, performed regularly, significantly reduced adverse pregnancy outcomes such as LBW, PTB, and PLBW. Funding: No external funding was received. 1. Introduction: Adverse pregnancy outcomes such as low birth weight (LBW), preterm birth (PTB), preterm low birth weight (PLBW) and pre-eclampsia are often related to the offspring facing multiple lifelong challenges, such as respiratory distress, impaired motor skills, cognitive and intellectual impairment, learning difficulties, and cardiovascular and metabolic disorders. 1,2 The relatively high incidence of periodontal disease, and especially of gingivitis, among pregnant women, 3 in combination with the fact that periodontal disease is both preventable and treatable, renders this potential association with APOs extremely important for health care providers. Receptors for female sex hormones like progesterone and estrogen have been identified in various periodontal cell subsets, 4,5 rendering periodontal tissues a possible target to the steady increase in these hormones during pregnancy. The severity of gingival inflammation is accentuated during the second and third gestational months without concomitant increase in plaque biofilm accumulation. 6,7 Periodontitis has also been shown to be present in pregnant women and such patients may experience progression of the disease with further loss of attachment. 8,9 It has been theorized that microorganisms, may invade the intrauterine environment and cause infection within various sites of the feto‐placental unit. 7,10–14 It is known that an infection and/or uncontrolled inflammatory reaction within the uterus may contribute to miscarriage or preterm birth via early membrane ruptures and uterine contraction. 10 Sites with periodontitis are a rich niche for pathognomic bacteria. 7,10,13 The presence of gingival inflammation during pregnancy and the increased tendency of the tissues to bleeding may enhance the leakage of periodontal pathogens from the infected periodontal tissues to the blood circulation. 7,10 These pathogens and their by‐products, together with associated inflammatory mediators, may spread via the hematogenous route between the periodontal tissues and the feto‐placental unit, 10,11 thus initiating an inflammatory response at the new site. 7,10,12–14 Recent studies have confirmed the intrauterine colonization with oral microbes. 10 Pregnant women with periodontitis seem to harbor various periodontal pathogens in their placenta more often than women with a healthy periodontium do. 10,11 Translocation of Porphyromonas gingivalis and Campylobacter rectus to placental tissues have been implicated to cause fetal growth restriction and PTB directly 10,13 or indirectly by an increase in serum and/or amniotic fluid levels of proinflammatory cytokines, such as interleukin‐1, interleukin‐6, and TNF‐α. 10 Hence, if the maternal periodontal health can be improved by non-surgical periodontal therapy during the course of pregnancy, the chances of APOs are reduced., This randomized controlled trial was designed to analyze and compare if non-surgical treatment of periodontal disease when performed once during pregnancy and when performed twice during pregnancy, can reduce the risk of APOs such as LBW, PTB, PLBW, stillbirth and complications of pregnancy like pre-eclampsia in a cohort of pregnant women in North India, when studied from baseline of 16 weeks of gestational age till parturition. 2. Materials and Methods This triple, parallel armed, randomized controlled trial with a prospective design, was undertaken in pregnant patients at the Department of Periodontology and Oral Implantology, Uttaranchal Dental and Medical Research Institute7, Mazri Grant, Dehradun, Uttarakhand. The study was examined and approved by the Review board of the Institutional Ethics Committee as per the certificate No: IEC/PA-11/2024. The study was conducted as per the guidelines in the World Health Organization’s Handbook for Good Clinical Practice. 15 The study was registered in Clinical Trials Registry of India (CTRI/2024/11/076267). The sex of the foetus was strictly never determined. All oral and/or periodontal care was carried out as per the recommendations enclosed in the first national consensus statement issued by the Oral Health Care During Pregnancy Expert Workgroup in 2012. 16 Supine hypotensive syndrome was managed by turning the patient on her left side and placing a 6-inch soft wedge ( i.e. , rolled towel) under the patient’s right side when she was reclined on the dental chair such that the head was above the level of the feet; this removes pressure on the vena cava and allows blood to return from the lower extremities and pelvic area. 17,18 Sample size: With a probability of LBW, PTB, PLBW and pre-eclampsia of 20-40% in the study population, a sample size of 60 pregnant women, was calculated to be sufficient to detect a significant difference of APOs with a confidence level of 0.95 and power of 0.90 (i.e. type I error or alpha = 0.05 and Type II error or beta = 0.1) Since, each participant needed to be monitored for a period upto about 16-28 weeks, sample attrition was expected and a dropout rate of 20% was anticipated. Hence, the sample size was adjusted to 75, i.e. 25 in each of three groups. Subject Enrollment: The participants selected were to be aged between 18-40 years, screened among healthy pregnant patients who visited for the ante natal care at our hospital. The inclusion criteria also included single gestation at ≤16 weeks and having least 20 completely erupted teeth, excluding the third molars. The participants were excluded from the study based on criteria such as previous history of LBW and/or PTB, more than 1 previous miscarriage or one greater than 18 weeks, participants having history of uncontrolled diabetes; hypertension; alcoholism; drug abuse and patients having other systemic diseases such as human immunodeficiency virus infection, heart disease, kidney disease or liver disease; recurrent cystitis; viral infections; venereal infections; toxoplasmosis. Patients having history of tobacco (smoking/smokeless) or alcohol were also excluded from the study. The participant who was able to come for the required recall appointments and was willing to participate in the study was enrolled with their informed consent. Randomization and Allotment: The participants were randomly allotted to three groups by the closed envelope system of random selection. By this method, 20 participants each were randomly allotted to each group of the study, namely ‘Control Group’, ‘Test Group 1’ and ‘Test Group 2’. Participant Preparation and Interventions: Periodontal therapy was performed by the same operator in all instances. The Test Group 1 patients received non-surgical periodontal therapy between weeks 16-20 gestational age (19GA). This consisted of oral hygiene education, followed by mechanical supra- and subgingival scaling and root planning. Periodontal therapy was performed over one to two consecutive sessions of not more than one hour and performed by one operator only. The oral hygiene education included instructions that comprised of the Bass tooth brushing method 19 and interdental cleansing with floss, toothpicks or interdental tooth brushes. The Test Group 2 patients received non-surgical periodontal therapy between weeks 16-20 weeks GA and on another occasion between 25-28 weeks. The procedures undertaken for participants in Test Group 2 at each of the two instances were the same that were performed for those in Test Group 1 during 16-20 weeks GA. The Control group received oral hygiene education at each of the recall appointments. No scaling and/or root planing procedures were performed. All control group participants were offered the opportunity to attend for non-surgical periodontal therapy post-partum. Routine antenatal care included periodic obstetric examinations, screening for pregnancy complications, nutritional advice, stress reduction, and education about symptoms of preterm labor. Ante-natal Care was conducted at monthly intervals for the first 32 weeks GA and at 2-weekly interval till 36-weeks and, thereafter at weekly interval till parturition. Ante-natal and obstetric care was provided by a single consultant in Obstetrics and Gynecology. Follow-up and Recording of Data: Demographic data and medical history were assessed by interview during the first visit (16-20 weeks GA). These and all other scores/measurements were recorded in the Case Proforma. The maternal characteristics recorded at enrolment were: (1) age, (2) marital status, (3) educational status, (4) area of residence as rural or urban, (5) body mass index, and (6) past obstetric history. Periodontal measurements and indices were recorded in three different time-points namely t1, t2 and t3 respectively for all participants. Time-point t1 at 16-20 weeks GA and before any oral hygiene instructions were given or any non-surgical periodontal therapy was performed. Time-point t2 at 21-24 weeks GA. Time-point t3 at 29-32 weeks GA. For participants of Test Group 2, it was so timed during gestational age 29-32 weeks that it was one month after any non-surgical periodontal therapy was performed. The following Periodontal indices/scores/measures were recorded at all above time-points: (1) Plaque Index, by Silness and Löe 20 , (2) Gingival index by Löe and Silness 21 (3) Bleeding on probing as described by Lang et al ., 22 (4) Pocket Probing Depth 23 (5) Clinical attachment Level (CAL) 23 The following obstetric measurements and outcomes variable were recorded shortly after delivery: (1) new-born weight in kilograms, (2) duration of pregnancy as GA weeks, (3) type of delivery (vaginal or caesarean), (4) APGAR score (Appearance, Pulse, Grimace, Activity, and Respiration), (5) need for Neonatal Intensive Care Unit admission. Adverse obstetric results were interpreted based upon WHO criteria 24 as follows: (1) low birth weight when the neonate weighs < 2.5 kg, (2) preterm birth when GA is < 37 weeks at delivery, (3) preterm low birth weight when both the neonatal weight is < 2.5 kg and pregnancy term is < 37 weeks, (4) pre-eclampsia defined as reading of systolic blood pressure ≥140 mm of mercury and diastolic blood pressure ≥90 mm at two occasions at least 4 hours apart after 20 weeks of gestation in a woman with previously normal blood pressure along with development of proteinuria (defined as absence of urinary infection), 25,26 and (5) stillbirth when there was fetal demise after 20weeks of gestation, and such demise diagnosed by lack of fetal heartbeat and nil APGAR score. 3. Statistical Analysis: The statistical analysis was carried out in IBM® SPSS Statistics for Windows®, version 26.0 (SPSS Inc., Chicago, Ill., USA). The mean values of each clinical parameter/index were compared between various time-points by using Analysis of Variance (ANOVA) and Bonferroni test. To confirm the significance of difference in mean values of clinical parameters, concurrently pairwise t-tests with Bonferroni correction between each group was conducted. The APOs were expressed as frequency and percentages. The association between periodontal health status as defined by the clinical parameters and different APOs was measured using Pearson Chi-square test for independence. Cramer’s V test was used to understand the strength of the relationship between two variables. A confidence interval of 95% was chosen and the asymptotic p-value (probability value) p≤0.05 was considered to be statistically significant. 4. Results Out of the 75 participants who were enrolled for the study, 9 participants did not return for follow up due to transportation issues, 4 participants parturiated at a different center, and 2 gave history of passive smoking during gestation period and were hence excluded from the study. Thus, data from only 60 participants that completed the study at the centre was included for statistical analysis as shown in the CONSORT flow chart in figure 1. The incidence of LBW was 7 (35%) in control group, 1 (5%) in test group 1 and none in test group 2. Nine (45%) pregnant women from control group, 3 (15%) in test group 1 and 3 (15%) in test group 2 had PTB. Occurrence of PLBW was seen only in the control group and involved 5 (25%) participants. Only 1 participant was diagnosed with pre-eclampsia during the study and she was in the control group. No case of stillbirth was noted in any group. The comparison of scores of various periodontal index at different time points in each group is shown in Table 1. The mean difference of the scores between time points with each group is shown in Table 2. There was significant change the mean scores of the indices between different time points. Table 3 shows in the control group, there was a statistically significant increase in the mean number of sites with pocket probing depth ≥ 4 mm through time-point t2 to t3 and between t1 and t3. In test group 1, there was a statistically significant decrease in the mean number of sites with pocket probing depth ≥4 mm between time-points t1 and t2 and between time-points t1 and t3, while there was a significant increase between time-points t2 to t3. In test group 2, the mean number of sites with pocket probing depth ≥ 4 mm there was significant reduction between time-points t1 and t2, t1 and t3, t2 and t3. At time-point t1 there was no statistically significant difference in the mean number of sites with pocket probing depth ≥ 4 mm between all three groups. At time-point t2, there was a statistically significant lesser number of sites with pocket probing depth ≥4mm in each of the test groups 1 and test group 2 when compared to the control group; whereas, there was no significant difference between test group 1 and 2. At time-point t3, the number of sites with pocket probing depth ≥ 4 mm was significantly more in control group than each of test group, and that in test group 1 was significantly higher than in test group 2. In control group, the mean number of sites with pocket probing depth ≥ 6 mm had increased significantly between time-points t1 and t3 and time-points t2 and t3. The test groups 1 and 2 did not show a significant difference in the mean number sites between all three time-points of follow-up. At time-point t1, the difference in the mean number of sites with pocket probing depth ≥ 6 mm amongst all three groups was not significant. At time-points t2 and t3, the control group had significantly more number of sites with pocket probing depth ≥ 6 mm than those at either of the tests groups 1 and 2. The difference between test group 1 and 2 it was not significant. There was a significant increase in the mean number of sites with interdental CAL ≥ 2 mm in control group between time-points t1 and t3 and time-points t2 and t3. In both test group 1 and 2, the difference in these mean number of sites were not statistically significant between any time-points. The difference in the mean number of sites with interdental interdental CAL ≥ 2 mm was not statistically different at any time-point in the study between all three groups. There was a significant increase in the mean number of sites with facio-lingual CAL ≥ 3 mm in control group and test group 1 between time-points t1 and t3 and time-points t2 and t3. In test group 2, the difference in these mean number of sites were not statistically significant between any time-points. Between control group and test group 2, the mean numbers were significantly decreased at time-point t3. The difference in the mean number of sites with facio-lingual CAL ≥ 3 mm was not statistically different at any time-point in the study between control group and test group 1 and also between test group 1 and 2. There was a significant increase in the mean number of sites with facio-lingual CAL ≥ 5 mm in control group between time-points t1 and t3 and time-points t2 and t3. In test group 1 and 2, the difference in these mean number of sites were not statistically significant between any time-points. Difference in the mean number of sites with facio-lingual CAL ≥ 5 mm was not statistically different at any time-point in the study between any of the three groups as shown in Table 4. At timepoint t3, the control group had 100% prevalence of periodontal disease and the frequency of occurrence of APO was 35% low birth weight, 45% pre term delivery, 20% preterm low birth weight and 5% for preeclampsia. While the test group 1 had 5% prevalence of healthy gingiva and 95% periodontal disease. The frequency of occurrence of APO in this group was 5% of low birth weight, 15% of preterm delivery and no other APO was noted. In test group 2, 70% was the prevalence of periodontal health and 30% had periodontal disease and the occurrence of APO was 15% of preterm delivery and no other APO was noted as shown in Table 5. The null hypothesis that, ‘the likelihood of an APO occurring in the control group or test group 1 or test group 2 are equal’ or in other words ‘the outcome variable of APO (like LBW, PTB, PLBW, preeclampsia, stillbirth) is independent of periodontal health status’. The Pearson’s Chi Square value for LBW, PTB, PLBW at time point t3 in control group rejected the null hypothesis and suggested an association of these adverse pregnancy outcomes and the periodontal health/disease status as shown in Table 6. For preeclampsia Pearson’s chi square value accepted the null hypotheses that there was no association between preeclampsia and periodontal health status. The strength of association between the APO and periodontal health/disease status was measured with Cramér’s V test. In control group and test group 1, the effect size was more than 0.2 and less than 0.6 suggestive of moderate strength of association. In test group 2, the effect size was >0.6 indicating a strong association between periodontal health status and APO as shown in Table 6. 5. Discussion The results of 2 case-control studies 27,28 and a cohort study 29 has showed that periodontal disease may potentially be an independent risk factor for PTB, LBW, and PLBW after adjusting for other risk factors. In the Indian context, Kumar et al ., 30 conducted a study among a total of 340 primigravida women in India of which 147 (43.23%) women had gingivitis and 61 (17.94%) women had periodontitis. They reported that periodontitis was significantly associated with pre-eclampsia, intrauterine growth restriction, PTB, and LBW with adjusted odds ratios (95% confidence interval) of 7.48, 3.35, 2.72 and 3.03, respectively. [51] In the present study, the group of women who received periodontal treatment (i.e. test group 1 and test group 2) had significantly fewer incidence of PTB, LBW and PLBW than women with untreated periodontal disease (control group). López et al ., 31 reported an incidence of LBW of 0.6% in the treatment group and 3.7% in the control group with no statistically significant difference between both groups. In a more elaborate study reported in 2005, Lopez et al ., 32 randomly assigned 870 pregnant Chilean women with gingivitis, aged 18 to 42, in a 2:1 fashion to either a treatment group (n = 580), that received periodontal treatment before 28 weeks of gestation or to a control group (n = 290), that received periodontal treatment only after delivery. The periodontal therapy rendered was plaque biofilm control instructions, scaling, and daily rinsing with 0.12% chlorhexidine. They too reported no significant difference in incidence of LBW and that being 0.7% in treatment group and 1.2% in control group (p = 0.79). Oliveira et al ., 33 reported an incidence of LBW of 20.4% in the treatment group and 27.7% in control group (p = 0.198) and a risk ratio for LBW of 0.74 (95% CI, 0.46‐1.18). All these studies, though showing low incidence of LBW in the test group receiving periodontal therapy during pregnancy, the difference in incidence vis à vis the control group has not been statistically significant. Pirie et al ., 34 reported an equal incidence of 2% LBW in both test and control group. Conversely, Tarannum and Faizuddin 35 reported an incidence of LBW of 26.3% in a group of Indian pregnant women receiving periodontal treatment and 53.9% in the control group that didn’t receive any periodontal scaling, (p < 0.002). Conversely, Radnai et al ., 36 reported a significantly lower incidence of LBW of 14.6% in treatment group as compared to 42.9% in control group (p = 0.007). In the present study, 35% LBW babies were recorded in the control group, 5% in the test group 1 and 0% were recorded in test group 2. The Pearson’s Chi Square value for LBW in control group was χ 2 (1, n=20) = 4.43, p=0.03, thus suggesting an association of LBW and the presence of periodontal disease in that group. Interestingly, in test group 2 no LBW was reported compared to one neonate having birth weight of <2.5 Kg in test group 1. This may indicate that the frequency of periodontal therapy may also play a positive role in reducing the occurrence of LBW, though it must be reiterated that this difference was not statistically significant. The influence of periodontal treatment of the mother and occurrence of PTB has been studied by a few researchers. 10,14 Tarannum and Faizuddin , 35 in their study reported the mean GA was 33.8 ±2.8 weeks and 32.7 ±2.8 weeks in the treatment and control groups, respectively with a significant difference at p <0.006. Reddy et al ., 37 performed an RCT in India that randomized 20 pregnant women with periodontitis. The treatment group (10 women) received oral hygiene instructions and SRP, whereas the control group (10 women) received only oral hygiene instructions. They noted a high prevalence of 10% of cases with PTB in the control group and nil cases in the treatment group. Similarly, Jeffcoat et al ., 38 reported incidence of PTB as 4.1% in test group (SRP performed) and 8.9% in control group. In the present study, the results are similar to the above findings. The Pearson’s Chi Square value for PTB was χ 2 (1, n=20) = 4.84, p=0.2, thus suggesting an association of PTB and the periodontal disease status. The lower prevalence of preterm birth infants in the treatment groups could be attributed to the pre-natal periodontal intervention. López et al ., 31 reported an incidence of PLBW of 1.8% (3/163) in test group and 10.1% (19/188) in control group (p = 0.003) when they prospectively examined 400 pregnant women from Chile. They delivered periodontal treatment before 28 weeks of gestation in the test group while the mothers in control group received periodontal treatment post-delivery. They reported that periodontal disease had the strongest association (odds ratio of 4.70) with PLBW, as compared to other risk factors like previous PLBW (3.98%), less than 6 pre-natal visits (3.70%) and maternal low weight gain (3.42%); also suggesting periodontal disease to be an independent risk factor for PLBW. In another study, López at al ., 32 reported an incidence of PLBW of 2.1% in test group and 6.7% in in control group (p=0.002); and an odds ratio of 2.76 for association of PLBW and gingivitis. Sadatmansouri et al ., 39 in Iranian women reported 0% PLBW in the test group and 26.7% in the control group. Radnai et al ., 36 also reported a significant decrease of incidence of PLBW of 9.8% in the group of pregnant mothers who received periodontal treatment as compared to an incidence of 33.3% in control group (p = 0.015). These findings are similar to the findings of the present study. In the present study, control group had 4 (20%) of the babies born with PLBW whereas, no babies with PLBW were reported in test group 1 and test group 2. The Pearson’s Chi Square value for PLBW was χ 2 (1, n=20) = 4.44, p=0.03, thus suggesting an association of PLBW and the periodontal disease status. The absence of PLBW in test groups could be attributed to periodontal intervention. Studies by Michalowicz et al ., 40 , Newnham et al ., 41 and Offenbacher et al ., 42 indicated that treatment of periodontal disease in pregnant women did not significantly alter the rates of pre-eclampsia. The above three studies respectively reported an incidence of pre-eclampsia of 7.6%, 3.4% and 7.6% in their periodontal treatment group in comparison to an incidence of 4.9%, 4.1% and 8.4% in their control groups; all with no statistically significant difference. In the present study, only one participant reported with pre-eclampsia in the control group and none were reported in either test group and this difference was not statistically significant. The Pearson’s Chi Square analysis revealed no association of this complication during pregnancy and the periodontal disease status. However, Kumar et al ., 30 did observe a significant difference in pre-eclampsia occurring in 18 (29.5%) pregnant women having periodontitis compared to 10 (6.8%) with gingivitis. Similar positive associations between periodontal disease and pre-eclampsia were reported by Boggess et al ., 3 Canakci et al ., 44 and Siqueira et al ., 45 showing an adjusted odds ratio (CI = 95%) of pre-eclampsia with periodontal disease as 2.4 (1.1–5.3); 3.47 (1.07–11.95) and 1.52 (1.01–2.29), respectively. Limitations of Study: All the three groups in the present study were not matched during enrolment as to their periodontitis or gingivitis or periodontal health status. A larger sample size would have probably allowed to perform a comparison of the intervention protocols in cohorts of periodontitis only or gingivitis only, or periodontal health only. It is well established that periodontitis is a chronic disease with periods of activity and periods of quiescence. Tests for C-reactive protein levels and interleukins as well as other immunological assays could help in determining the status of activity of the oral disease and correlate that with the incidence of APOs. 46 6. Conclusion Within the limitations of this study, it is concluded that non-surgical periodontal treatment performed during pregnancy either during 16-20 weeks or additionally at 21-24 weeks gestational age is safe for mother and fetus. It has been seen that in an Uttarakhand population, such non-surgical periodontal therapy can control or eliminate periodontal infection and reduce the risk of LBW, PTB, PLBW. Further, when there is presence of gingivitis or periodontitis in the mothers, during 25-28 weeks GA, there is a moderate association of occurrence of LBW, PTB and PLBW but not of pre-eclampsia. Since there was no case of stillbirth or low APGAR score noted post-partum, there was no analysis available on these two variables. However, it is also clear that further research is needed to fully understand the mechanisms by which periodontal health or rather periodontal disease(s) affect pregnancy outcomes and to establish standardized treatment protocols. It is imperative for healthcare providers to recognize the importance of periodontal health in expectant mothers and to work collaboratively across disciplines to ensure the best possible holistic care for the pregnant woman. References 1. Mathews TJ, MacDorman MF. Infant mortality statistics from the 2003 period linked birth/infant death data set. Natl Vital Stat Rep Cent Dis Control Prev Natl Cent Health Stat Natl Vital Stat Syst . 2006;54(16):1-29. 2. Chang HH, Larson J, Blencowe H, et al. Preventing preterm births: analysis of trends and potential reductions with interventions in 39 countries with very high human development index. Lancet Lond Engl . 2013;381(9862):223-234. doi:10.1016/S0140-6736(12)61856-X 3. Saigal S, Doyle LW. An overview of mortality and sequelae of preterm birth from infancy to adulthood. Lancet Lond Engl . 2008;371(9608):261-269. doi:10.1016/S0140-6736(08)60136-1 4. Flemmig TF. Periodontitis. Ann Periodontol . 1999;4(1):32-38. doi:10.1902/annals.1999.4.1.32 5. Sanz M, Kornman K, working group 3 of the joint EFP/AAP workshop. Periodontitis and adverse pregnancy outcomes: consensus report of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases. J Periodontol . 2013;84(4 Suppl):S164-169. doi:10.1902/jop.2013.1340016 6. Caneiro-Queija L, López-Carral J, Martin-Lancharro P, Limeres-Posse J, Diz-Dios P, Blanco-Carrion J. Non-Surgical Treatment of Periodontal Disease in a Pregnant Caucasian Women Population: Adverse Pregnancy Outcomes of a Randomized Clinical Trial. Int J Environ Res Public Health . 2019;16(19):3638. doi:10.3390/ijerph16193638 7. Madianos PN, Bobetsis YA, Offenbacher S. Adverse pregnancy outcomes (APOs) and periodontal disease: pathogenic mechanisms. J Clin Periodontol . 2013;40 Suppl 14:S170-180. doi:10.1111/jcpe.12082 8. Hartnett E, Haber J, Krainovich-Miller B, Bella A, Vasilyeva A, Lange Kessler J. Oral Health in Pregnancy. J Obstet Gynecol Neonatal Nurs JOGNN . 2016;45(4):565-573. doi:10.1016/j.jogn.2016.04.005 9. Fakheran O, Keyvanara M, Saied-Moallemi Z, Khademi A. The impact of pregnancy on women’s oral health-related quality of life: a qualitative investigation. BMC Oral Health . 2020;20(1):294. doi:10.1186/s12903-020-01290-5 10. Bobetsis YA, Graziani F, Gürsoy M, Madianos PN. Periodontal disease and adverse pregnancy outcomes. Periodontol 2000 . 2020;83(1):154-174. doi:10.1111/prd.12294 11. Bui FQ, Almeida-da-Silva CLC, Huynh B, et al. Association between periodontal pathogens and systemic disease. Biomed J . 2019;42(1):27-35. doi:10.1016/j.bj.2018.12.001 12. Figuero E, Han YW, Furuichi Y. Periodontal diseases and adverse pregnancy outcomes: Mechanisms. Periodontol 2000 . 2020;83(1):175-188. doi:10.1111/prd.12295 13. Fischer LA, Demerath E, Bittner-Eddy P, Costalonga M. Placental colonization with periodontal pathogens: the potential missing link. Am J Obstet Gynecol . 2019;221(5):383. doi:10.1016/j.ajog.2019.04.029 14. Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. Treating periodontal disease for preventing adverse birth outcomes in pregnant women. Cochrane Database Syst Rev . 2017;6(6):CD005297. doi:10.1002/14651858.CD005297.pub3 15. Weltgesundheitsorganisation, ed. Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation . World Health Organization; 2005. 16. Agrawal N, Aggarwal A, Gupta ND, Tewari RK, Gupta J, Garg AK. Oral Health Consequences of Use of Smokeless Tobacco in North India: A Cross-Sectional Survey. Pesqui Bras Em Odontopediatria E Clínica Integrada . 2021;21:e0114. doi:10.1590/pboci.2021.025 17. Otomo-Corgel J. Periodontal therapy in the female patient. In: Newman MG, Takei HH, Klokkevold PR, Carranza FA editors. Newman and Carranza’s Clinical Periodontology. 13 ed. Philadelphia: Elsevier Inc; 2019. pp. 465-74. 18. Steinberg BJ, Hilton IV, Iida H, Samelson R. Oral health and dental care during pregnancy. Dent Clin North Am . 2013;57(2):195-210. doi:10.1016/j.cden.2013.01.002 19. Bass CC. An effective method of personal oral hygiene. J La State Med Soc Off Organ La State Med Soc . 1954;106(2):57-73; contd. 20. Silness J, Loe H. Periodontal disease in pregnancy. II. Correlation between oral hygiene and periodontal condition. Acta Odontol Scand . 1964;22:121-135. doi:10.3109/00016356408993968 21. Loe H, Silness J. Periodontal disease in pregnancy. I. Prevalence and severity. Acta Odontol Scand . 1963;21:533-551. doi:10.3109/00016356309011240 22. Lang NP, Adler R, Joss A, Nyman S. Absence of bleeding on probing. An indicator of periodontal stability. J Clin Periodontol . 1990;17(10):714-721. doi:10.1111/j.1600-051x.1990.tb01059.x 23. Do JH, Takei HH, Carranza FA. Chapter 32. Periodontal examination and diagnosis. In: Newman MG, Takei HH, Klokkevold PR, Carranza FA (eds) Newman and Carranza’s Clinical Periodontology, 13 ed. Philadelphia: Elsevier; 2018, pp. 378-96. 24. ICD10Volume2_en_2010.pdf. Accessed November 1, 2024. https://icd.who.int/browse10/Content/statichtml/ICD10Volume2_en_2010.pdf 25. ACOG Committee on Obstetric Practice. ACOG practice bulletin. Diagnosis and management of preeclampsia and eclampsia. Number 33, January 2002. American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet Off Organ Int Fed Gynaecol Obstet . 2002;77(1):67-75. 26. Report of the National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy. Am J Obstet Gynecol . 2000;183(1):S1-S22. 27. Dasanayake AP. Poor periodontal health of the pregnant woman as a risk factor for low birth weight. Ann Periodontol . 1998;3(1):206-212. doi:10.1902/annals.1998.3.1.206 28. Offenbacher S, Katz V, Fertik G, et al. Periodontal infection as a possible risk factor for preterm low birth weight. J Periodontol . 1996;67(10 Suppl):1103-1113. doi:10.1902/jop.1996.67.10s.1103 29. López NJ, Smith PC, Gutierrez J. Higher risk of preterm birth and low birth weight in women with periodontal disease. J Dent Res . 2002;81(1):58-63. doi:10.1177/002203450208100113 30. Kumar A, Basra M, Begum N, et al. Association of maternal periodontal health with adverse pregnancy outcome. J Obstet Gynaecol Res . 2013;39(1):40-45. doi:10.1111/j.1447-0756.2012.01957.x 31. López NJ, Smith PC, Gutierrez J. Periodontal therapy may reduce the risk of preterm low birth weight in women with periodontal disease: a randomized controlled trial. J Periodontol . 2002;73(8):911-924. doi:10.1902/jop.2002.73.8.911 32. López NJ, Da Silva I, Ipinza J, Gutiérrez J. Periodontal therapy reduces the rate of preterm low birth weight in women with pregnancy-associated gingivitis. J Periodontol . 2005;76(11 Suppl):2144-2153. doi:10.1902/jop.2005.76.11-S.2144 33. Oliveira AMSD, de Oliveira PAD, Cota LOM, Magalhães CS, Moreira AN, Costa FO. Periodontal therapy and risk for adverse pregnancy outcomes. Clin Oral Investig . 2011;15(5):609-615. doi:10.1007/s00784-010-0424-8 34. Pirie M, Linden G, Irwin C. Intrapregnancy non-surgical periodontal treatment and pregnancy outcome: a randomized controlled trial. J Periodontol . 2013;84(10):1391-1400. doi:10.1902/jop.2012.120572 35. Tarannum F, Faizuddin M. Effect of periodontal therapy on pregnancy outcome in women affected by periodontitis. J Periodontol . 2007;78(11):2095-2103. doi:10.1902/jop.2007.060388 36. Radnai M, Pál A, Novák T, Urbán E, Eller J, Gorzó I. Benefits of periodontal therapy when preterm birth threatens. J Dent Res . 2009;88(3):280-284. doi:10.1177/0022034508330229 37. Reddy BVR, Tanneeru S, Chava VK. The effect of phase-I periodontal therapy on pregnancy outcome in chronic periodontitis patients. J Obstet Gynaecol J Inst Obstet Gynaecol . 2014;34(1):29-32. doi:10.3109/01443615.2013.829029 38. Jeffcoat MK, Hauth JC, Geurs NC, et al. Periodontal disease and preterm birth: results of a pilot intervention study. J Periodontol . 2003;74(8):1214-1218. doi:10.1902/jop.2003.74.8.1214 39. Sadatmansouri S, Sedighpoor N, Aghaloo M. Effects of periodontal treatment phase I on birth term and birth weight. J Indian Soc Pedod Prev Dent . 2006;24(1):23-26. doi:10.4103/0970-4388.22831 40. Michalowicz BS, Hodges JS, DiAngelis AJ, et al. Treatment of periodontal disease and the risk of preterm birth. N Engl J Med . 2006;355(18):1885-1894. doi:10.1056/NEJMoa062249 41. Newnham JP, Newnham IA, Ball CM, et al. Treatment of periodontal disease during pregnancy: a randomized controlled trial. Obstet Gynecol . 2009;114(6):1239-1248. doi:10.1097/AOG.0b013e3181c15b40 42. Offenbacher S, Beck JD, Jared HL, et al. Effects of periodontal therapy on rate of preterm delivery: a randomized controlled trial. Obstet Gynecol . 2009;114(3):551-559. doi:10.1097/AOG.0b013e3181b1341f 43. Boggess KA, Lieff S, Murtha AP, Moss K, Beck J, Offenbacher S. Maternal periodontal disease is associated with an increased risk for preeclampsia. Obstet Gynecol . 2003;101(2):227-231. doi:10.1016/s0029-7844(02)02314-1 44. Canakci V, Canakci CF, Canakci H, et al. Periodontal disease as a risk factor for pre-eclampsia: a case control study. Aust N Z J Obstet Gynaecol . 2004;44(6):568-573. doi:10.1111/j.1479-828X.2004.00323.x 45. Siqueira FM, Cota LOM, Costa JE, Haddad JPA, Lana AMQ, Costa FO. Maternal periodontitis as a potential risk variable for preeclampsia: a case-control study. J Periodontol . 2008;79(2):207-215. doi:10.1902/jop.2008.070174 46. Khairnar MS, Pawar BR, Marawar PP, Khairnar DM. Estimation of changes in C-reactive protein level and pregnancy outcome after nonsurgical supportive periodontal therapy in women affected with periodontitis in a rural set up of India. Contemp Clin Dent . 2015;6(Suppl 1):S5-S11. doi:10.4103/0976-237X.152930 Supplementary Material File (flowchart1_2.jpg) Download 8.56 MB File (tables.docx) Download 24.80 KB Information & Authors Information Version history V1 Version 1 22 January 2026 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords antenatal care general gynaecology randomised controlled trials Authors Affiliations Aaron F. Gomes Uttaranchal Dental College and Medical Research Institute View all articles by this author Preeti Pandey Uttaranchal Hospital View all articles by this author Meru S 0000-0001-7936-4664 [email protected] Uttaranchal Dental College and Medical Research Institute View all articles by this author Metrics & Citations Metrics Article Usage 119 views 56 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Aaron F. Gomes, Preeti Pandey, Meru S. Effect of Non-surgical Periodontal Therapy on Risk of Adverse Pregnancy Outcomes: A Randomized Controlled Trial in Indian Population.. Authorea . 22 January 2026. DOI: https://doi.org/10.22541/au.176905090.07457903/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . Format Please select one from the list RIS (ProCite, Reference Manager) EndNote BibTex Medlars RefWorks Direct import Tips for downloading citations document.getElementById('citMgrHelpLink').addEventListener('click', function() { popupHelp(this.href); return false; }); $(".js__slcInclude").on("change", function(e){ if ($(this).val() == 'refworks') $('#direct').prop("checked", false); $('#direct').prop("disabled", ($(this).val() == 'refworks')); }); View Options View options PDF View PDF Figures Tables Media Share Share Share article link Copy Link Copied! Copying failed. Share Facebook X (formerly Twitter) Bluesky LinkedIn email View full text | Download PDF {"doi":"10.22541/au.176905090.07457903/v1","type":"Article"} Now Reading: Share Figures Tables Close figure viewer Back to article Figure title goes here Change zoom level Go to figure location within the article Download figure Toggle share panel Toggle share panel Share Toggle information panel Toggle information panel Go to previous graphic Go to next graphic Go to previous table Go to next table All figures All tables View all material View all material xrefBack.goTo xrefBack.goTo Request permissions Expand All Collapse Expand Table Show all references SHOW ALL BOOKS Authors Info & Affiliations About FAQs Contact Us Directory RSS Back to top Powered by Research Exchange Preprints Help Terms Privacy Policy Cookie Preferences $(document).ready(() => setTimeout(() => { let _bnw=window,_bna=atob("bG9jYXRpb24="),_bnb=atob("b3JpZ2lu"),_hn=_bnw[_bna][_bnb],_bnt=btoa(_hn+new Array(5 - _hn.length % 4).join(" ")); $.get("/resource/lodash?t="+_bnt); },4000)); (function(){function c(){var b=a.contentDocument||a.contentWindow.document;if(b){var d=b.createElement('script');d.innerHTML="window.__CF$cv$params={r:'9fe2929ba9038e2e',t:'MTc3OTE4ODE2MQ=='};var a=document.createElement('script');a.src='/cdn-cgi/challenge-platform/scripts/jsd/main.js';document.getElementsByTagName('head')[0].appendChild(a);";b.getElementsByTagName('head')[0].appendChild(d)}}if(document.body){var a=document.createElement('iframe');a.height=1;a.width=1;a.style.position='absolute';a.style.top=0;a.style.left=0;a.style.border='none';a.style.visibility='hidden';document.body.appendChild(a);if('loading'!==document.readyState)c();else if(window.addEventListener)document.addEventListener('DOMContentLoaded',c);else{var e=document.onreadystatechange||function(){};document.onreadystatechange=function(b){e(b);'loading'!==document.readyState&&(document.onreadystatechange=e,c())}}}})();