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
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Bleeding on probing
研究概览
简要总结
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.
详细描述
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%.It 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.
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 There exists a pathological imbalance of Luteinizing Hormone(LH) and Follicle Stimulating Hormone (FSH) in women with PCOS which explains the rationale for treatment with combined hormonal treatment.11 These treatments include combined oral contraceptives (COCs) and anti androgen tharapy (ADT) in the form of antiandrogenic progestogen/ ethinylestradiol (EE) combinations.
Receptors for estrogen have been demonstrated in the gingiva and periodontal connective tissue cells 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.
The present study aims to evaluate the periodontal status of female patients diagnosed with PCOS on CPA/EE combination regimen.
MATERIALS AND METHODS- The present cross-sectional study will be 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 in Female patients diagnosed with PCOS.It will include 150 individuals, who will be comprised into 3 groups and the individuals in each group will be recruited as Test group 1- Female patients diagnosed with PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Ultrasound exclusion of PCOS
排除标准
- •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
研究组 & 干预措施
Test group 1
FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS.
干预措施: Cyproterone Acetate, Ethinyl Estradiol Drug Combination (Drug)
Test group 2
FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,
干预措施: FEMALE PATIENTS WITH PCOS (Diagnostic Test)
Control group
SYSTEMICALLY HEALTHY FEMALES
干预措施: Control group (Diagnostic Test)
结局指标
主要结局
Bleeding on probing
时间窗: 6 months
Percentage of bleeding sites on probing
Pocket depth
时间窗: 6 months
Distance from gingival margin to base of the pocket
HsCRP levels
时间窗: 6 months
C reactive protein levels in serum
次要结局
未报告次要终点