"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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rohtak, Haryana, India
Patients applied
Trial Officials
Ridhima Singhal, BDS
Principal Investigator
PGIDS,ROHTAK
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials