Evaluation of the Effect of Non-Surgical Periodontal Treatment in Women With Polycystic Ovary Syndrome

August 20, 2024 updated by: Bezmialem Vakif University

Evaluation of the Effect of Non-Surgical Periodontal Treatment on IL-6, IL-10 and ANXA-1 Levels in Women With Polycystic Ovary Syndrome

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:

  1. Is gum disease more common in women with PCOS?
  2. Does PCOS affect the response to gum disease treatment?
  3. Is there a new marker to identify gum disease? It is known that polycystic ovary syndrome is a low-grade chronic inflammatory disease. It has been reported that this aspect may be associated with gum disease. In our study, women with polycystic ovary syndrome will be compared with systemic healthy women. Initial gum conditions and response after treatment will be investigated. Additionally, the results will be supported by gingival crevicular fluid and saliva analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34080
        • Bezmialem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 18-40 with polycystic ovary syndrome and healthy periodontium
  • Women aged 18-40 with polycystic ovary syndrome and gingivitis
  • Women aged 18-40 who are systemically healthy and have gingivitis
  • Women aged 18-40 who are systemically healthy and have a healthy periodontium
  • Presence of at least 20 permanent teeth

Exclusion Criteria:

  • Receiving anti-inflammatory or antimicrobial therapy in the past three months
  • Smoking and alcohol consumption
  • Body mass index > 30 kg/m2
  • Individuals with diabetes mellitus, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid disorders, Cushing's syndrome, hypertension, liver or kidney dysfunction
  • Medication that may affect metabolic criteria, such as oral contraceptive agents, any steroid hormone or related preparations, hypertensive drugs and insulin sensitizing drugs
  • Pregnancy and breastfeeding
  • Receiving periodontal treatment in the last 6 months
  • Taking any medication known to affect periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, coumadin, steroidal non-anti-inflammatory drugs, aspirin > 81 mg)
  • Active infectious diseases such as hepatitis, HIV or tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: PCOS and Healthy Periodontium
Women who are diagnosed with PCOS and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained.
Active Comparator: PCOS and Gingivitis
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
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.
Other Names:
  • Scaling and root planing
Active Comparator: Systemically healthy and Gingivitis
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
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.
Other Names:
  • Scaling and root planing
No Intervention: Systemically and Periodontally Healthy
Women who are systemically healthy and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing
Time Frame: Baseline and sixth weeks after the treatment
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.
Baseline and sixth weeks after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-6
Time Frame: Baseline and sixth weeks after the treatment
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Baseline and sixth weeks after the treatment
Interleukin-10
Time Frame: Baseline and sixth weeks after the treatment
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Baseline and sixth weeks after the treatment
Annexin A1
Time Frame: Baseline and sixth weeks after the treatment
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Baseline and sixth weeks after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Director: Sadiye Gunpinar, Assoc.Prof, Affiliated
  • Principal Investigator: Cansu Can Yasar, Dr., Affiliated
  • Study Chair: Seda Ates, Prof., Affiliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

November 22, 2022

Study Completion (Actual)

February 8, 2023

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYASAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data could be shared if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Polycystic Ovary Syndrome

Clinical Trials on Non-surgical periodontal treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe