Periodontal DiseasesNCT05657171
"Effect of CPA/EE Drug on Periodontal Tissue and hsCRP Levels in PCOS Patients With Gingivitis
An observational study of Periodontal Diseases, 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
- Periodontal Diseases
- What is being tested?
- cyproterone Acetate/Ethinyl Estradiol Combination
- How many people
- 47 participants
- Where
- 1 siteIndia
- Study dates
- 12 Dec 2022to 30 Dec 2023
- 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 having gingivitis
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 11Show fewer
- 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.
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.
About this study
Official title: "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."
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..
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%. 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
- Being tested
- cyproterone Acetate/Ethinyl Estradiol Combination
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyproterone Acetate/Ethinyl Estradiol CombinationDrug
Also called Diane 35
cyproterone acetate (CPA) 2 mg, combined with EE 35 µg.
| Study group | Role | What they receive |
|---|---|---|
| PCOS +GINGIVITIS | FEMALE PATIENTS WITH PCOS AND GINGIVITIS ON CPA/EE DRUG REGIMEN Receives: Drug: cyproterone Acetate/Ethinyl Estradiol Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Plaque index
Plaque index by Silness and Loe (1964) will be used for assessment of plaque. For the scoring, a mouth mirror, an explorer and a light source will be used on air dried teeth and gingiva.
Measured: 6 months
Gingival index
Gingival Index by Loe and Silness (1963) will be used for assessment of severity of gingival inflammation. For the scoring, a mouth mirror, a probe and a light source will be used on air dried teeth and gingiva.
Measured: 6 months
Gingival recession
Gingival recession is defined as the apical shift of the gingival margin with respect to the cemento-enamel junction (CEJ); it is associated with attachment loss and with exposure of the root surface to the oral environment
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 posted20 Dec 2022
- Study start12 Dec 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ridhima Singhal, BDS, Principal investigator, PGIDS,ROHTAK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657171
- Sponsor's protocol ID
- Dr Ridhima perio/22/25
- Status last verified
- Oct 2024
- First submitted
- 10 Dec 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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."
- ClinicalTrials.gov ID
- NCT05657171
- Acronym / sponsor ID
- Dr Ridhima perio/22/25
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 20 Dec 2022 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCOS +GINGIVITIS | – | Drug: cyproterone Acetate/Ethinyl Estradiol CombinationFEMALE PATIENTS WITH PCOS AND GINGIVITIS ON CPA/EE DRUG REGIMEN |
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 having gingivitis
Key inclusion criteria (11 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)
- Presence of gingivitis
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 CombinationAlso: Diane 35cyproterone acetate (CPA) 2 mg, combined with EE 35 µg. | Drug | PCOS +GINGIVITIS |
Primary outcome
Bleeding on probing (BOP)
Time frame: 6 months
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
CLINICAL ATTACHMENT LEVEL (CAL)
Time frame: 6 months
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.
PROBING POCKET DEPTH (PPD)
Time frame: 6 months
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.
hsCRP Levels
Time frame: 6 months
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.
3 secondary outcomes
Plaque index
Time frame: 6 months
Gingival index
Time frame: 6 months
Gingival recession
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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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, BDS 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 Periodontal Diseases, 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 11 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: finished, as of the sponsor's last update on 16 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (BOP) (time frame: 6 months). The study lists 4 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 16 Oct 2024.