An interventional study of Non-surgical periodontal treatment in Polycystic Ovary Syndrome and Gingivitis, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare women with polycystic ovary syndrome and systemically healthy woman in relation to their gums and gum treatment outcomes as well as to investigate the role of a new biomarker in gum disease. The main questions it aims to answer are:
Polycystic ovary syndrome (PCOS) is an endocrine disorder characterized by hyperandrogenism, polycystic ovaries, and ovulatory dysfunction, affecting 4-21 % of women worldwide. It has been shown that PCOS has an impact on both local and systemic proinflammatory markers, along with periodontal disease, but the relationship between them remains unclear. The aim of this study is to compare the clinical and biochemical response to periodontal treatment between individuals with PCOS and gingival inflammation and those with systemic health, as well as to investigate the role of annexin-1 (ANXA1) biomarker in gingival inflammation.
Taking previous studies as a reference and considering the bleeding on probing variable as 45.12 and 82.94, respectively, and standard deviations as 37.46 and 13.59, respectively, the sample size for a 95% confidence level and 80% power at a 0.05 significance level was calculated as 15 people per group and n=60 in total. Considering that participants may drop out of the study, the sample size was determined as 20 people per group and n = 80 people in total.
A total of 80 participants were included, 40 individuals diagnosed with PCOS and 40 systemically healthy volunteers. Following periodontal examinations of all individuals, they were divided into four groups: a) PCOSPS (diagnosed with PCOS and healthy periodontium, n=20), b) PCOSG (diagnosed with PCOS and gingivitis, n=20), c) SG (systemically healthy individuals with gingivitis, n=20), and d) SPS (systemically healthy individuals with healthy periodontium, n=20). After gynecological and ultrasonographic examinations, as well as recording anthropometric measurements of all participants, hormonal tests were analysed. For the evaluation of periodontal status, clinical periodontal measurements were taken at the beginning of the study and at the 6th week after non-surgical periodontal treatment (NSPT) in the gingivitis groups. Gingival crevicular fluid (GCF) and saliva samples were collected at the beginning of the study and repeated at the 6th week after NSPT to assess the levels of interleukin-6 (IL-6), IL-10, and ANXA1. Biochemical analysis of all samples was performed using the enzyme-linked immunosorbent assay (ELISA) method.
An identification form was prepared to keep participants' records, including their personal and contact information. Gingival crevicular fluid tracking form to record when the gingival fluid samples were taken, which participant they belonged to, and from which dental area they were taken; saliva sample tracking form to record when the saliva samples were taken and which participant they belong to; periodontal index form to record plaque score, bleeding on probing, gingival pocket depth, gingival recession and attachment level during periodontal examination; polycystic ovary syndrome form containing the participants' medical information and a modified Ferriman-Gallwey score form was prepared to determine and record the degree of hirsutism.
Statistical analysis of the data obtained as a result of the study was performed in the IBM SPSS Statistics 26.0 program at a significance level of 0.05 and a confidence level of 95%. The distribution of the data was examined with the Shapiro-Wilk test. Comparisons between four independent groups with normal distribution were made with the One Way Anova test, and comparisons between four independent groups with non-normal distribution were made with the Kruskal Wallis test. Variables that were significant as a result of four group comparisons were compared with the Dunn-Bonferroni post-hoc test. If the variables met the assumption of normal distribution, comparisons between two independent groups were made with the Independent Sample t test. Chi-Square test or Fisher-Freeman-Halton test was used to evaluate the difference between categorical variables. In examining the relationship between numerical variables, Spearman (non-normally distributed) and Pearson (normally distributed) correlation coefficients were evaluated. The changes in time-dependent variables within and between groups were examined with the Repeated Anova test. While the descriptive statistics of the data were explained as mean and standard deviation or median (minimum-maximum), the descriptive statistics of categorical variables were given as frequency (%). ROC (Receiver Operating Characteristics) curve analysis was performed using Medcalc Version 12.3 to determine the distinctiveness of the ANXA1 variant.
591 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 80 is above the median of 63 across 479 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
Women who are diagnosed with PCOS and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained.
Women who are diagnosed with PCOS and have gingivitis.Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. Non-surgical periodontal treatment was performed.
Procedure: Non-surgical periodontal treatment
Women who are systemically healthy and have gingivitis. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. Non-surgical periodontal treatment was performed.
Procedure: Non-surgical periodontal treatment
Women who are systemically healthy and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained.
Non-surgical periodontal treatment was performed in a single session using an ultrasonic device and a manual scaler. Polishing was done using polishing paste and rubber cup. Clinical periodontal indices, saliva and gingival crevicular samples were repeated after six weeks follow-up period.
Also known as: Scaling and root planing
Bleeding on probing
Bleeding on probing is an important indicator of gingivitis. Bleeding on probing less than 10% is an indicator of healthy periodontium and means that the non-surgical periodontal treatment is successful.
Time frame: Baseline and sixth weeks after the treatment
Interleukin-6
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Time frame: Baseline and sixth weeks after the treatment
Interleukin-10
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Time frame: Baseline and sixth weeks after the treatment
Annexin A1
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Time frame: Baseline and sixth weeks after the treatment
Plan to share: No — Data could be shared if requested.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Bezmialem Vakif University