Evaluation of Periodontal Status and hsCRP Levels in Females With PCOS on CPA/EE Combination Drug Regimen

NCT05021861 | Unknown DMC

• 1 other identifier: RidhimaPerio
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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

Periodontitis; Polycystic Ovary Syndrome; Gingivitis

Outcome Measures

Primary Outcomes (3)

• Bleeding on probing

  Percentage of bleeding sites on probing

  6 months

• Pocket depth

  Distance from gingival margin to base of the pocket

  6 months

• HsCRP levels

  C reactive protein levels in serum

  6 months

Study Arms (3)

Test group 1

FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS.

Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination

Test group 2

FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,

Diagnostic Test: FEMALE PATIENTS WITH PCOS

Control group

SYSTEMICALLY HEALTHY FEMALES

Diagnostic Test: Control group

Interventions

Cyproterone Acetate, Ethinyl Estradiol Drug Combination DRUG

FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS

Also known as: Diane-35

Test group 1

FEMALE PATIENTS WITH PCOS DIAGNOSTIC_TEST

FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,

Test group 2

Control group DIAGNOSTIC_TEST

SYSTEMICALLY HEALTHY FEMALES

Control group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female patients diagnosed with PCOS on CPA/EE combination drug regimen.

You may qualify if:

• 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); and
• 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
• Regular mensturation,
• No clinical or biochemical sign of hyperandrogenism and

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Science

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontitis; Polycystic Ovary Syndrome; Gingivitis

Interventions

Cyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infections; Gingival Diseases

Study Officials

• RIDHIMA SINGHAL

  PGIDS,ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SHIKHA TEWARI, MDS

CONTACT

01262-281876; drshihatewari@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 26, 2021
• Study Start: November 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2022
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

IN (1)