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

NCT05657171 | Completed DMC

• 1 other identifier: Dr Ridhima perio/22/25
• Study Type: observational
• Target: 47
• 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 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..

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (4)

• Bleeding on probing (BOP)

  BOP will be recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as % sites with bleeding on probing

  6 months

• CLINICAL ATTACHMENT LEVEL (CAL)

  Clinical Attachment Level will be measured as the distance between the base of the clinical pocket and the cemento-enamel junction(CEJ).Measurements will be made at 6 sites of involved tooth- mesio-buccal, mid- buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual using UNC-15 probe. Measurements will be rounded to the nearest whole millimetre. Distance of base of the pocket from gingival margin, distance of free gingival margin from CEJ.

  6 months

• PROBING POCKET DEPTH (PPD)

  Probing pocket depth will be measured as the distance from the gingival margin to the base of the clinical pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP-UNC 15 Hu-Friedy, Chicago, IL, USA). The probe will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of involved tooth - mesio-buccal, mid-buccal, disto-buccal, mesio- lingual, mid-lingual, disto-lingual. Measurements will be rounded to the nearest whole millimetre.

  6 months

• hsCRP Levels

  Blood samples for the investigation of serum hsCRP will be collected after overnight fasting. Venous blood from the antecubital vein will be collected after applying a tourniquet in plain tubes without additive. Serum hsCRP levels will be assessed using a kit‡ with high sensitivity methodology in an auto-analyzer§ according to the manufacturer's instructions. The test principle will be particle-enhanced immune- turbidimetric assay, in which human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies.

  6 months

Secondary Outcomes (3)

• Plaque index

  6 months

• Gingival index

  6 months

• Gingival recession

  6 months

Study Arms (1)

PCOS +GINGIVITIS

FEMALE PATIENTS WITH PCOS AND GINGIVITIS ON CPA/EE DRUG REGIMEN

Drug: cyproterone Acetate/Ethinyl Estradiol Combination

Interventions

cyproterone Acetate/Ethinyl Estradiol Combination DRUG

cyproterone acetate (CPA) 2 mg, combined with EE 35 µg.

Also known as: Diane 35

PCOS +GINGIVITIS

Eligibility Criteria

• Age: 15 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients diagnosed with PCOS having gingivitis

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)
• Presence of gingivitis
• Gingivitis 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.

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 Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Cyproterone Acetate; Cyproterone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Ridhima Singhal, BDS

  PGIDS,ROHTAK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 20, 2022
• Study Start: December 12, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)