PeriodontitisNCT05021861
Evaluation of Periodontal Status and hsCRP Levels in Females With PCOS on CPA/EE Combination Drug Regimen
An observational study of Periodontitis and Polycystic Ovary Syndrome, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Periodontitis, Polycystic Ovary Syndrome, Gingivitis
- What is being tested?
- Cyproterone Acetate, Ethinyl Estradiol Drug Combination and FEMALE PATIENTS WITH PCOS
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Female patients diagnosed with PCOS on CPA/EE combination drug regimen.
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Dental Science
Rohtak, Haryana, 124001
TEWARI, 01262283876, principalpgids@yahoo.in
About this study
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
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.
Read the 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.
- Conditions
- Periodontitis, Polycystic Ovary Syndrome, Gingivitis
- Being tested
- Cyproterone Acetate, Ethinyl Estradiol Drug Combination, FEMALE PATIENTS WITH PCOS, Control group
- Medical subject headings
- Periodontitis, Polycystic Ovary Syndrome, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproterone Acetate, Ethinyl Estradiol Drug CombinationDrug
Also called Diane-35
FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS
FEMALE PATIENTS WITH PCOSDiagnostic test
FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,
Control groupDiagnostic test
SYSTEMICALLY HEALTHY FEMALES
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS. Receives: Drug: Cyproterone Acetate, Ethinyl Estradiol Drug Combination | |
| Test group 2 | FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION, Receives: Diagnostic Test: FEMALE PATIENTS WITH PCOS | |
| Control group | SYSTEMICALLY HEALTHY FEMALES Receives: Diagnostic Test: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Percentage of bleeding sites on probing
Measured: 6 months
Pocket depth
Distance from gingival margin to base of the pocket
Measured: 6 months
HsCRP levels
C reactive protein levels in serum
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study startNov 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RIDHIMA SINGHAL, Principal investigator, PGIDS,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021861
- Sponsor's protocol ID
- RidhimaPerio
- Status last verified
- Nov 2021
- First submitted
- 19 Aug 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05021861
- Acronym / sponsor ID
- RidhimaPerio
- Conditions
- Periodontitis, Polycystic Ovary Syndrome, Gingivitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | – | Drug: Cyproterone Acetate, Ethinyl Estradiol Drug CombinationFEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS. |
| Test group 2 | – | Diagnostic Test: FEMALE PATIENTS WITH PCOSFEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION, |
| Control group | – | Diagnostic Test: Control groupSYSTEMICALLY HEALTHY FEMALES |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female patients diagnosed with PCOS on CPA/EE combination drug regimen.
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyproterone Acetate, Ethinyl Estradiol Drug CombinationAlso: Diane-35FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS | Drug | Test group 1 |
| FEMALE PATIENTS WITH PCOSFEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION, | Diagnostic test | Test group 2 |
| Control groupSYSTEMICALLY HEALTHY FEMALES | Diagnostic test | Control group |
Primary outcome
Bleeding on probing
Time frame: 6 months
Percentage of bleeding sites on probing
Pocket depth
Time frame: 6 months
Distance from gingival margin to base of the pocket
HsCRP levels
Time frame: 6 months
C reactive protein levels in serum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RIDHIMA SINGHAL principal investigator
PGIDS,ROHTAK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Polycystic Ovary Syndrome, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SHIKHA TEWARI, MDS (01262-281876, drshihatewari@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.