NCT05129878

Effect of EE/NETA With Scaling on Periodontium and hsCRP in PCOS Women With Gingivitis

Effect of COCs Ethinylestradiol/Norethisterone Acetate Along With Scaling on Periodontal Health and hsCRP in Polycystic Ovary Syndrome Women Having Gingivitis : A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
• Sex: Female
• Age: 15 Years – 40 Years
• Healthy volunteers: Accepted

Summary

As gingivitis is known to add to the systemic inflammatory burden and may consequently contribute to progression of PCOS and vice-versa, So, controlling local and systemic inflammatory burden by scaling g and medical treatment may have an effect in the management of PCOS women having gingivitis.There is no data as yet, comparing the impact of COCs along with scaling and COCs along with just oral hygiene instructions on the periodontal health of PCOS patients. Therefore, there is need to study the effect of combined oral contraceptives (ethinylestradiol/norethisterone acetate) along with scaling on periodontal status and high sensitivity C-Reactive Protein in polycystic ovary syndrome women having gingivitis

Detailed description

Various studies have been conducted to assess the impact of oral contraceptives on periodontal status and mostly present conflicting results. However, none of these studies have been carried out on females diagnosed with PCOS. Such an assessment is significant keeping in mind the increasing prevalence of PCOS as well as introduction of low-dose oral contraceptives for the long-term management of these patients. Additionally, gingivitis is known to increase the systemic inflammatory burden and may possibly contribute to progression of PCOS and vice-versa. So, controlling both local and systemic inflammatory burden by scaling along with medical treatment may have a vital role in the management of PCOS women having gingivitis. There is no data as yet, evaluating the impact of COCs on the periodontal health of PCOS patients. Therefore, the effect of hormone based medical treatment on the periodontal status of these patients, whether protective or destructive, remains unclear till date. The present study, thus, aims to evaluate the effect of combined oral contraceptives (ethinylestradiol / norethisterone acetate) with and without scaling on the periodontal status and the levels of serological marker of inflammation {high sensitivity-C Reactive Protein (hsCRP)} among polycystic ovarian syndrome (PCOS) women having ginigvitis. MATERIAL AND METHODOLOGY STUDY DESIGN AND SETTING- The present randomised controlled clinical trial will be conducted in the Department of Periodontology, Post Graduate Institute of Dental Sciences, Rohtak in collaboration with Department of Obstetrics and Gynecology, Post Graduate Institute of Medical Sciences, Rohtak. STUDY PERIOD- 12-14 months STUDY SUBJECTS- PCOS patients having gingivitis,15-40 years of age and systemically healthy patients with gingivitis All the participants will be age and BMI matched. The present Randomized Controlled Trial will include 60 individuals of PCOS who will be divided into 2 groups using randomisation software. Generating randomization table.and allocation will be concealed in opaque envelops by another person not involved in the trial.30 systemically healthy females,age and BMI matched, will also be included. Test group 1 , n=30, patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions (OHI) and Scaling. Test group 2, n=30, patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only Control Group , n=30, Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and scaling. Periodontal and anthropometric parameters will be measured and sampling will be done at baseline, 3months and 6 months. serum hsCRP levels will be assessed at baseline and at 6 months. TEST GROUP AND CONTROL GROUPS - Periodontal parameters: - 1. PLAQUE INDEX 2. GINGIVAL INDEX 3. BLEEDING ON PROBING 4. GINGIVAL BIOTYPE 5. GINGIVAL RECESSION 6. ANALYSES OF ANTHROPOMETRIC PARAMETERS- Waist circumference (WC) waist-to-hip ratio (WHR) BMI(Kg/m²) 7. hsCRP LEVELS 8. PCOSQ (Polycystic ovary syndrome questionnaire) 9. ORAL HEALTH RELATED QUALITY OF LIFE (OHRqol) questionnaire 10. Phenotype of PCOS DATA MANAGEMENT AND STATISTICAL ANALYSIS Data recorded will be processed by standard statistical analysis.The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to distribution of data. If it is in normal distribution inter group comparison will be done by using Independent T test and paired t test will be use for intragroup comparison and if non-normal distribution of data, inter group comparison will be done by Mann-Whitney U test and intragroup by signed rank test. The Chi square test will be applied to analyze categoric data. Correlation and association between predictors and dependent variables will be analyzed by correlation analysis and regression analysis.

Conditions

• Gingivitis
• PCOS

Interventions

Type	Name	Description
PROCEDURE	scaling and OHI	patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions
PROCEDURE	oral Hygiene instructions	patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only
PROCEDURE	Scaling and oral hygiene instruction	Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and Scaling

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-11-20
• Completion: 2022-11-20
• First posted: 2021-11-22
• Last updated: 2023-08-24

Locations

2 sites across 1 country: India