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NCT05657171
"Effect of CPA/EE Drug on Periodontal Tissue and hsCRP Levels in PCOS Patients With Gingivitis
Conditions: Periodontal Diseases
Sex: Female
Ages: 15 Years – 40 Years
Enrollment: 50
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Location: India
Summary
PCOS is a widely reported condition among young female population and anti-androgen agents are increasingly being used as part of the medical management of such cases.
However, Clinical studies have reported higher prevalence of gingival inflammation, loss of attachment and gingival enlargement in women taking hormone based oral contraceptives.
Additionally, CPA has been reported to have an osteoclastic action.
Therefore, it is necessary to explore the effects of these medications on the periodontal condition of PCOS patients having gingivitis, who already are pre-disposed to systemic inflammation.
Therefore, the present study aims to longitudinally evaluate the effect of CPA/EE combination regimen on the periodontal status of female patients diagnosed with PCOS with pre-existing gingivitis..
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:clinical (hirsutism, acne or acanthosis nigricans) and/or biochemical (raised testosterone) hyperandrogenism ;chronic anovulation (oligomenorrhoea or amenorrhea); andpolycystic 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 teethBMI (18.5 - 24.9)Presence of gingivitisGingivitis with intact periodontium - BOP ≥ 10% of sites , with pockets ≤ 3mm, no probing attachment loss and no radiographic bone loss .Gingivitis with reduced periodontium - BOP ≥ 10% of sites , with pockets ≤ 3mm with possible probing attachment loss and possible radiographic bone loss.Localized gingivitis - 10 to 30%of bleeding sites.Generaized gingivitis - more than 30% of beeding sites.Exclusion Criteria:Previous history of androgen-secreting tumors, congenital adrenal hyperplasia , hyperprolactinemia, or any thyroid dysfunctionPatients 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 yearsSmokers 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
Source: ClinicalTrials.gov (NCT05657171). StuddyBuddy aggregates publicly available trial information.