Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05021861
Recruitment Status : Not yet recruiting
First Posted : August 26, 2021
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

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.

Condition or disease Intervention/treatment
Periodontitis Polycystic Ovary Syndrome Gingivitis Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination Diagnostic Test: FEMALE PATIENTS WITH PCOS Diagnostic Test: Control group

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%.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.

Test group 2- Female patients diagnosed with PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION, Control group -SYSTEMICALLY HEALTHY FEMALES

The primary outcome measures include bleeding on probing (BOP),Probing pocket depth(PPD),Clinical attachment level(CAL),Serum High Sensitivity C- reactive Proteins (hsCRP).SECONDARY MEASURES include Plaque index, Gingival index,Gingival phenotype,Gingival recession,Demographic parameters ( Education status, Socio-economic status),Anthropometric parameters (Waist circumference, waist to hip ratio, Body mass index) ,Quality of life ( via PCOS Questionnaire, Oral health related Questionnaire).

DATA MANAGEMENT AND STATISTICAL ANALYSIS - Data recorded will be processed by standard statistical analysis.The normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis will be performed according to distribution of data. If it is in normal distribution inter group comparison will be done by using Independent T test between signed rank test and if in non-normal distribution inter group comparison will be done by Mann-Whitney U test. The Chi square test will be applied to analyze categoric data. Correlation and association between predictors and dependent variables will be analyzed by correlation analysis and regression analysis.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: 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
Estimated Study Start Date : August 20, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022


Group/Cohort Intervention/treatment
Test group 1
FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS.
Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination
FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS
Other Name: Diane-35

Test group 2
FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,
Diagnostic Test: FEMALE PATIENTS WITH PCOS
FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,

Control group
SYSTEMICALLY HEALTHY FEMALES
Diagnostic Test: Control group
SYSTEMICALLY HEALTHY FEMALES




Primary Outcome Measures :
  1. Bleeding on probing [ Time Frame: 6 months ]
    Percentage of bleeding sites on probing

  2. Pocket depth [ Time Frame: 6 months ]
    Distance from gingival margin to base of the pocket

  3. HsCRP levels [ Time Frame: 6 months ]
    C reactive protein levels in serum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-representation of gender identity
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients diagnosed with PCOS on CPA/EE combination drug regimen.
Criteria

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 study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021861


Contacts
Layout table for location contacts
Contact: SHIKHA TEWARI, MDS 01262-281876 drshihatewari@yahoo.com

Locations
Layout table for location information
India
Post Graduate Institute of Dental Science
Rohtak, Haryana, India, 124001
Contact: TEWARI    01262283876    principalpgids@yahoo.in   
Sponsors and Collaborators
Postgraduate Institute of Dental Sciences Rohtak
Investigators
Layout table for investigator information
Principal Investigator: RIDHIMA SINGHAL PGIDS,ROHTAK
Layout table for additonal information
Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT05021861    
Other Study ID Numbers: RidhimaPerio
First Posted: August 26, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingivitis
Polycystic Ovary Syndrome
Periodontitis
Syndrome
Disease
Pathologic Processes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Infections
Gingival Diseases
Cyproterone Acetate
Ethinyl Estradiol
Estradiol
Cyproterone
Cyproterone acetate, ethinyl estradiol drug combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents