Clinical trial · Observational
Evaluation of Periodontal Status and hsCRP Levels in Females With PCOS on CPA/EE Combination Drug Regimen
Evaluation of Periodontal Status and High Sensitivity C Reactive Protein Levels in Female Patients Diagnosed With Polycystic Ovary Syndrome on Cyproterone Acetate/Ethinyl Estradiol Combination Regimen: a Cross Sectional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 whether these medications affect the periodontal condition of PCOS patients, who already are pre-disposed to systemic inflammation. Therefore, the present study aims to evaluate the periodontal status of female patients diagnosed with Polycystic Ovary syndrome on Cyproterone acetate/ethinyl estradiol combination regimen.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gingivitis | — | UNRESOLVED | — |
| Periodontitis | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Diagnostic Test | — | UNRESOLVED |
| Cyproterone Acetate, Ethinyl Estradiol Drug Combination | Drug | — | UNRESOLVED |
| FEMALE PATIENTS WITH PCOS | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Test group 1
- description
- FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS.
- interventionNames
- Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination
- label
- Test group 2
- description
- FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,
- interventionNames
- Diagnostic Test: FEMALE PATIENTS WITH PCOS
- label
- Control group
- description
- SYSTEMICALLY HEALTHY FEMALES
- interventionNames
- Diagnostic Test: Control group
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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)
* Systemically healthy females {Age and BMI matched with PCOS women} diagnosed on the basis of
1. Regular mensturation,
2. No clinical or biochemical sign of hyperandrogenism and
3. Ultrasound exclusion of PCOS
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 studyReferences
Publications (0)
Data not yet available