Effect of EE/NETA With Scaling on Periodontium and hsCRP in PCOS Women With Gingivitis
Condition: Gingivitis; PCOS
MeSH terms: Gingivitis
Study type: Interventional

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.
    

Intervention name(s): scaling and OHI; oral Hygiene instructions; Scaling and oral hygiene instruction
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions; patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only; Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and Scaling
Other intervention name(s): Education and motivation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment