NCT05657171

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

"Effect of Cyproterone Acetate / Ethinyl Estradiol Combination on Periodontal Tissue and High Sensitivity C- Reactive Protein Levels in Women With Polycystic Ovary Syndrome Having Gingivitis."

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
• Sex: Female
• Age: 15 Years – 40 Years
• Healthy volunteers: Not accepted

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..

Detailed description

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 linked to elevated CRP levels. Also, elevated C-reactive protein (CRP) levels are associated with PCOS. It has been hypothesised that PCOS might exacerbate the periodontal condition that is caused by dental plaque, through various pathophysiological links, namely, low-grade systemic inflammation, oxidative stress, insulin resistance (IR), advanced glycation end products (AGE), and systemic hormonal levels. Evidence has suggested that periodontal disease causes chronic subclinical inflammation leading to Insulin resistance, initiating the development of type 2 diabetes, which in turn is a prominent feature in PCOS. Hence, a two-way relationship between PCOS and periodontal disease is currently being explored. The imbalance of Luteinizing Hormone(LH) and Follicle Stimulating Hormone (FSH) in women with PCOS explains the rationale for treatment with combined hormonal treatment.One such therapy is cyproterone acetate (CPA) 2 mg, combined with EE 35 µg. CPA is a steroidal antiandrogen progestogen while EE is one of the most potent oral estrogens .EE enhances the action of CPA by increasing sex hormone binding globulin (SHBG) levels, which leads to a reduction in free testosterone and thus adds to the antiandrogenic action of CPA. Receptors for estrogen have been demonstrated in the gingiva and periodontal connective tissue cells .The use of hormonal contraceptives by women has been reported to influence periodontal disease progression. While the effects of different contraceptive combinations and/or oral hypoglycemics on the periodontal condition of female patients diagnosed with PCOS has been explored, the specific drug combination of CPA/EE has not been studied in detail as yet. 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. The present cohort study is conducted in the Department of periodontology, Post Graduate Institute of Dental Sciences, Rohtak in collaboration with Department of Obstetrics and Gynaecology Post Graduate Institute of Medical Sciences, Rohtak over a period of 12-14 months. The study population comprised of female patients diagnosed with PCOS having gingivitis.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
DRUG	cyproterone Acetate/Ethinyl Estradiol Combination	cyproterone acetate (CPA) 2 mg, combined with EE 35 µg.

Timeline

• Start date: 2022-12-12
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-12-20
• Last updated: 2024-10-16

Locations

1 site across 1 country: India