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"Effect of CPA/EE Drug on Periodontal Tissue and hsCRP Levels in PCOS Patients With Gingivitis

Launched by POSTGRADUATE INSTITUTE OF DENTAL SCIENCES ROHTAK · Dec 10, 2022

Trial Information

Current as of April 26, 2025

Completed

Keywords

ClinConnect Summary

Polycystic ovary syndrome (PCOS) is a complex endocrine, reproductive and metabolic condition, affecting women of reproductive age globally with a worldwide prevalence ranging from 5-15%. PCOS is associated with low-grade systemic inflammation and is characterised by elevation of multiple markers of inflammation such as C-reactive protein (CRP), proinflammatory cytokines and chemokines, white blood cell count as well as increased oxidative stress.CRP is a serologic marker of systemic inflammation that has been associated with increased risk for various systemic diseases. Gingivitis has been...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • * Females of age group (15-40yrs) diagnosed with PCOS. The diagnosis of PCOS will be according to Rotterdam criteria, when any two out of the following three abnormalities will be present:
  • 1. clinical (hirsutism, acne or acanthosis nigricans) and/or biochemical (raised testosterone) hyperandrogenism ;
  • 2. chronic anovulation (oligomenorrhoea or amenorrhea); and
  • 3. polycystic ovaries on ultrasound (one or both ovaries demonstrate 12 or more follicles measuring 2 to 9 mm in diameter or the ovarian volume exceeds 10 cubic cm on pelvic ultrasound) from department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Sciences, Rohtak.
  • presence of ≥20 natural teeth
  • BMI (18.5 - 24.9)
  • Presence of gingivitis
  • 1. Gingivitis with intact periodontium - BOP ≥ 10% of sites , with pockets ≤ 3mm, no probing attachment loss and no radiographic bone loss .
  • 2. Gingivitis with reduced periodontium - BOP ≥ 10% of sites , with pockets ≤ 3mm with possible probing attachment loss and possible radiographic bone loss.
  • 3. Localized gingivitis - 10 to 30%of bleeding sites.
  • 4. Generaized gingivitis - more than 30% of beeding sites.
  • Exclusion Criteria:
  • Previous history of androgen-secreting tumors, congenital adrenal hyperplasia , hyperprolactinemia, or any thyroid dysfunction
  • Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, or active cancer within the past 5 years
  • Smokers and alcoholics,
  • History of systemic antibiotics or oral contraceptives usage within last 3 months,
  • Periapical pathology or other oral inflammatory conditions and any periodontal treatment within 6 months prior to study

About Postgraduate Institute Of Dental Sciences Rohtak

The Postgraduate Institute of Dental Sciences, Rohtak, is a premier academic institution dedicated to advancing dental education, research, and clinical practice. With a commitment to fostering innovation in oral health, the institute is actively engaged in conducting clinical trials that aim to enhance treatment methodologies and improve patient outcomes. By integrating cutting-edge research with comprehensive training, the institute plays a pivotal role in shaping the future of dental sciences, while adhering to the highest ethical standards and regulatory guidelines in clinical research.

Locations

Rohtak, Haryana, India

Patients applied

0 patients applied

Trial Officials

Ridhima Singhal, BDS

Principal Investigator

PGIDS,ROHTAK

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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