GingivitisNCT05129878
Effect of EE/NETA With Scaling on Periodontium and hsCRP in PCOS Women With Gingivitis
A study testing scaling and OHI, oral Hygiene instructions and Scaling and oral hygiene instruction in people with Gingivitis and PCOS, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
Trial summary
As gingivitis is known to add to the systemic inflammatory burden and may consequently contribute to progression of PCOS and vice-versa, So, controlling local and systemic inflammatory burden by scaling g and medical treatment may have an effect in the management of PCOS women having gingivitis.There is no data as… Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, PCOS
- What is being tested?
- scaling and OHI, oral Hygiene instructions and Scaling and oral hygiene instruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jan 2022to 20 Nov 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For test groups
- females of reproductive age group (15-40 yrs)
- BMI (18.5 - 24.9)
- The diagnosis of PCOS according to Rotterdam criteria(37), 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) 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)
- presence of ≥20 natural teeth
Show all 12Show fewer
- gingivitis by using the criteria laid down by World Workshop 2017
- For Test Group 2
- Participants will receive professional oral hygiene instructions during the trial and will be given cause related treatment after observation period of 6 months.
- Delaying treatment will not be considered unethical because of the low risk of disease progression over 6 months (41) and because these individuals will be monitored frequently and offered immediate (rescue) treatment if their disease progresses. Such cases will be excluded from the study. Periodontitis progression will be defined as an increase in CAL of 2 mm at any tooth site(42).
- Participants will be enrolled in the present study after obtaining written informed consent after explaining the details of the study design in their native language.
- Also, patients with periodontitis or molar incisor pattern of periodontitis (2017 criteria) will not be included in the study For control group Systemically healthy females (age and BMI matched with PCOS women) diagnosed on the basis of regular menstruation, no clinical or biochemical sign of hyperandrogenism and ultrasound exclusion of PCOS, having gingivitis.
Who cannot join
- • history of androgen-secreting tumors, congenital adrenal hyperplasia and thyroid dysfunction
- nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, active cancer within the last past 5 yrs
- smokers and alcoholics
- history of systemic antibiotics or oral contraceptives usage within last 3 months
- periapical pathology or oral inflammatory conditions other than periodontitis.
- any periodontal treatment within 6 months prior to study
- incisor molar pattern/grade C periodontitis (2017 classification)
Trial locations and contacts
2 sites in 1 country.
India2 sites
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Shikha Tewari
Rohtak, Haryana, 124001
About this study
Official title: Effect of COCs Ethinylestradiol/Norethisterone Acetate Along With Scaling on Periodontal Health and hsCRP in Polycystic Ovary Syndrome Women Having Gingivitis : A Randomized Controlled Trial
As gingivitis is known to add to the systemic inflammatory burden and may consequently contribute to progression of PCOS and vice-versa, So, controlling local and systemic inflammatory burden by scaling g and medical treatment may have an effect in the management of PCOS women having gingivitis.There is no data as yet, comparing the impact of COCs along with scaling and COCs along with just oral hygiene instructions on the periodontal health of PCOS patients. Therefore, there is need to study the effect of combined oral contraceptives (ethinylestradiol/norethisterone acetate) along with scaling on periodontal status and high sensitivity C-Reactive Protein in polycystic ovary syndrome women having gingivitis
Read the detailed description
Various studies have been conducted to assess the impact of oral contraceptives on periodontal status and mostly present conflicting results. However, none of these studies have been carried out on females diagnosed with PCOS. Such an assessment is significant keeping in mind the increasing prevalence of PCOS as well as introduction of low-dose oral contraceptives for the long-term management of these patients. Additionally, gingivitis is known to increase the systemic inflammatory burden and may possibly contribute to progression of PCOS and vice-versa. So, controlling both local and systemic inflammatory burden by scaling along with medical treatment may have a vital role in the management of PCOS women having gingivitis. There is no data as yet, evaluating the impact of COCs on the periodontal health of PCOS patients. Therefore, the effect of hormone based medical treatment on the periodontal status of these patients, whether protective or destructive, remains unclear till date. The present study, thus, aims to evaluate the effect of combined oral contraceptives (ethinylestradiol / norethisterone acetate) with and without scaling on the periodontal status and the levels of serological marker of inflammation {high sensitivity-C Reactive Protein (hsCRP)} among polycystic ovarian syndrome (PCOS) women having ginigvitis.
MATERIAL AND METHODOLOGY STUDY DESIGN AND SETTING- The present randomised controlled clinical trial will be conducted in the Department of Periodontology, Post Graduate Institute of Dental Sciences, Rohtak in collaboration with Department of Obstetrics and Gynecology, Post Graduate Institute of Medical Sciences, Rohtak.
STUDY PERIOD- 12-14 months STUDY SUBJECTS- PCOS patients having gingivitis,15-40 years of age and systemically healthy patients with gingivitis All the participants will be age and BMI matched. The present Randomized Controlled Trial will include 60 individuals of PCOS who will be divided into 2 groups using randomisation software. Generating randomization table.and allocation will be concealed in opaque envelops by another person not involved in the trial.30 systemically healthy females,age and BMI matched, will also be included.
Test group 1 , n=30, patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions (OHI) and Scaling.
Test group 2, n=30, patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only Control Group , n=30, Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and scaling.
Periodontal and anthropometric parameters will be measured and sampling will be done at baseline, 3months and 6 months. serum hsCRP levels will be assessed at baseline and at 6 months.
TEST GROUP AND CONTROL GROUPS - Periodontal parameters: -
- PLAQUE INDEX
- GINGIVAL INDEX
- BLEEDING ON PROBING
- GINGIVAL BIOTYPE
- GINGIVAL RECESSION
- ANALYSES OF ANTHROPOMETRIC PARAMETERS- Waist circumference (WC) waist-to-hip ratio (WHR) BMI(Kg/m²)
- hsCRP LEVELS
- PCOSQ (Polycystic ovary syndrome questionnaire)
- ORAL HEALTH RELATED QUALITY OF LIFE (OHRqol) questionnaire
- Phenotype of PCOS
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 and paired t test will be use for intragroup comparison and if non-normal distribution of data, inter group comparison will be done by Mann-Whitney U test and intragroup by signed rank 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
- Gingivitis, PCOS
- Being tested
- scaling and OHI, oral Hygiene instructions, Scaling and oral hygiene instruction
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and OHIProcedure or surgery
patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions
oral Hygiene instructionsProcedure or surgery
Also called Education and motivation
patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only
Scaling and oral hygiene instructionProcedure or surgery
Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and Scaling
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | Experimental | patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions (OHI) Receives: Procedure: scaling and OHI |
| Test group 2 | Experimental | patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only Receives: Procedure: oral Hygiene instructions |
| Control Group | Active comparator | Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and scaling. Receives: Procedure: Scaling and oral hygiene instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing (BOP)
BOP will 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
Serum high sensitivity C reactive protein (hsCRP) levels
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 the latex particles coated with monoclonal anti-CRP antibodies.
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 posted22 Nov 2021
- Study start1 Jan 2022
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RICHA VERMA, Principal investigator, Post Graduate Institute of Dental Sciences,ROHTAK,HARYANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129878
- Sponsor's protocol ID
- RICHA PERIO
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2021
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COCs Ethinylestradiol/Norethisterone Acetate Along With Scaling on Periodontal Health and hsCRP in Polycystic Ovary Syndrome Women Having Gingivitis : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05129878
- Acronym / sponsor ID
- RICHA PERIO
- Conditions
- Gingivitis, PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 22 Nov 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.
As gingivitis is known to add to the systemic inflammatory burden and may consequently contribute to progression of PCOS and vice-versa, So, controlling local and systemic inflammatory burden by scaling g and medical treatment may have an effect in the management of PCOS women having gingivitis.There is no data as yet, comparing the impact of COCs along with scaling and COCs along with just oral hygiene instructions on the periodontal health of PCOS patients. Therefore, there is need to study the effect of combined oral contraceptives (ethinylestradiol/norethisterone acetate) along with scaling on periodontal status and high sensitivity C-Reactive Protein in polycystic ovary syndrome women having gingivitis
Detailed description
Various studies have been conducted to assess the impact of oral contraceptives on periodontal status and mostly present conflicting results. However, none of these studies have been carried out on females diagnosed with PCOS. Such an assessment is significant keeping in mind the increasing prevalence of PCOS as well as introduction of low-dose oral contraceptives for the long-term management of these patients. Additionally, gingivitis is known to increase the systemic inflammatory burden and may possibly contribute to progression of PCOS and vice-versa. So, controlling both local and systemic inflammatory burden by scaling along with medical treatment may have a vital role in the management of PCOS women having gingivitis. There is no data as yet, evaluating the impact of COCs on the periodontal health of PCOS patients. Therefore, the effect of hormone based medical treatment on the periodontal status of these patients, whether protective or destructive, remains unclear till date. The present study, thus, aims to evaluate the effect of combined oral contraceptives (ethinylestradiol / norethisterone acetate) with and without scaling on the periodontal status and the levels of serological marker of inflammation {high sensitivity-C Reactive Protein (hsCRP)} among polycystic ovarian syndrome (PCOS) women having ginigvitis.
MATERIAL AND METHODOLOGY STUDY DESIGN AND SETTING- The present randomised controlled clinical trial will be conducted in the Department of Periodontology, Post Graduate Institute of Dental Sciences, Rohtak in collaboration with Department of Obstetrics and Gynecology, Post Graduate Institute of Medical Sciences, Rohtak.
STUDY PERIOD- 12-14 months STUDY SUBJECTS- PCOS patients having gingivitis,15-40 years of age and systemically healthy patients with gingivitis All the participants will be age and BMI matched. The present Randomized Controlled Trial will include 60 individuals of PCOS who will be divided into 2 groups using randomisation software. Generating randomization table.and allocation will be concealed in opaque envelops by another person not involved in the trial.30 systemically healthy females,age and BMI matched, will also be included.
Test group 1 , n=30, patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions (OHI) and Scaling.
Test group 2, n=30, patients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only Control Group , n=30, Systemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and scaling.
Periodontal and anthropometric parameters will be measured and sampling will be done at baseline, 3months and 6 months. serum hsCRP levels will be assessed at baseline and at 6 months.
TEST GROUP AND CONTROL GROUPS - Periodontal parameters: -
- PLAQUE INDEX
- GINGIVAL INDEX
- BLEEDING ON PROBING
- GINGIVAL BIOTYPE
- GINGIVAL RECESSION
- ANALYSES OF ANTHROPOMETRIC PARAMETERS- Waist circumference (WC) waist-to-hip ratio (WHR) BMI(Kg/m²)
- hsCRP LEVELS
- PCOSQ (Polycystic ovary syndrome questionnaire)
- ORAL HEALTH RELATED QUALITY OF LIFE (OHRqol) questionnaire
- Phenotype of PCOS
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 and paired t test will be use for intragroup comparison and if non-normal distribution of data, inter group comparison will be done by Mann-Whitney U test and intragroup by signed rank 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | Experimental | Procedure: scaling and OHIpatients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions (OHI) |
| Test group 2 | Experimental | Procedure: oral Hygiene instructionspatients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only |
| Control Group | Active comparator | Procedure: Scaling and oral hygiene instructionSystemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and scaling. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- For test groups
- females of reproductive age group (15-40 yrs)
- BMI (18.5 - 24.9)
- The diagnosis of PCOS according to Rotterdam criteria(37), 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) 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)
Key exclusion criteria (7 listed)
- • history of androgen-secreting tumors, congenital adrenal hyperplasia and thyroid dysfunction
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 |
|---|---|---|
| scaling and OHIpatients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive scaling and oral hygiene instructions | Procedure or surgery | Test group 1 |
| oral Hygiene instructionsAlso: Education and motivationpatients with PCOS on combined oral contraceptives (COCs) having gingivitis will receive oral hygiene instructions only | Procedure or surgery | Test group 2 |
| Scaling and oral hygiene instructionSystemically Healthy (age and BMI matched) females with gingivitis will receive with OHI and Scaling | Procedure or surgery | Control Group |
Primary outcome
Bleeding on probing (BOP)
Time frame: 6 months
BOP will 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.
Serum high sensitivity C reactive protein (hsCRP) levels
Time frame: 6 months
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 the latex particles coated with monoclonal anti-CRP antibodies.
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 24 Aug 2023.
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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.
RICHA VERMA principal investigator
Post Graduate Institute of Dental Sciences,ROHTAK,HARYANA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaling and OHI, oral Hygiene instructions and Scaling and oral hygiene instruction in people with Gingivitis and PCOS, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites 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 12 inclusion and 7 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 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 24 Aug 2023.