GingivitisNCT05639608
EFFECT OF SCALING ON SERUM hsCRP LEVELS AND PERIODONTAL PARAMETERS IN SYSTEMICALLY HEALTHY YOUNG WOMEN WITH GINGIVITIS
A study testing SCALING in people with Gingivitis, run by Postgraduate Institute of Dental Sciences Rohtak at 2 sites in India.
Trial summary
Gingivitis is a highly prevalent chronic bacterial disease in susceptible children, adults and the elderly, persisting for decades in subjects, and is an essential precursor of periodontitis. Several studies have shown periodontitis and subgingival P. 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
- What is being tested?
- SCALING
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Dec 2022to 31 Jul 2023
- 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
- females of reproductive age group (18-40 yrs)
- BMI (18.5 - 24.9)
- presence of ≥20 natural teeth
- Healthy periodontium (for control group) defined as bleeding on probing at < 10% of sites, with pockets ≤3 mm, no probing attachment loss and no radiologic bone loss.
- Gingivitis (17) (for test group) Gingivitis (intact periodontium) is defined as bleeding on probing at ≥ 10% of sites, with pockets ≤3 mm, no probing attachment loss and no radiologic bone loss.
- Gingivitis (reduced periodontium) is defined as bleeding on probing at ≥ 10% of sites with pockets ≤3 mm with possible probing attachment loss and possible radiologic bone loss.
- Localized gingivitis is defined as 10-30% of bleeding sites. Generalized gingivitis is defined as more than 30% of bleeding sites.
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 years
- smokers and alcoholics
- history of systemic antibiotics or oral contraceptives usage within last 3 months
- periapical pathology or oral inflammatory conditions other than gingivitis.
- any periodontal treatment within 6 months prior to study Patients with pockets ≥ 3 mm and probing attachment loss shall be excluded, hence, radiographic examination will not be needed.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Shikha Tewari, MDS
Shikha Tewari
Rohtak, Haryana, 124001
About this study
Official title: EFFECT OF SCALING ON SERUM hsCRP LEVELS AND PERIODONTAL PARAMETERS IN SYSTEMICALLY HEALTHY WOMEN OF REPRODUCTIVE AGE GROUP WITH GINGIVITIS: AN INTERVENTIONAL STUDY
Gingivitis is a highly prevalent chronic bacterial disease in susceptible children, adults and the elderly, persisting for decades in subjects, and is an essential precursor of periodontitis. Several studies have shown periodontitis and subgingival P. gingivalis to be associated with increased C-reactive protein (CRP) levels and CRP has been implicated as a possible mediator of the association between periodontitis and several systemic diseases Limited data are available today addressing detrimental systemic effects of experimental or natural gingivitis as they have been rarely investigated. Results of various studies support the concept that gingivitis leads to systemic inflammation and that the level of systemic inflammatory markers increases proportionately with increase in gingival inflammation. It has also been seen that appropriate dental prophylaxis can also limit systemic markers of inflammation in subjects with natural gingivitis. Sex hormones have long been considered to play an influential role on periodontal tissues, bone turnover rate, wound healing and periodontal disease progression and can influence the cellular proliferation, differentiation and growth of keratinocytes and fibroblasts. Estrogen is mainly responsible for alterations in blood vessels and progesterone stimulates the production of inflammatory mediators. In addition, some micro-organisms found in the human mouth synthesize enzymes needed for steroid synthesis and catabolism. Sex hormones are neither necessary nor sufficient to produce gingival changes by themselves. However, they may alter periodontal tissue responses to microbial plaque and thus indirectly contribute to periodontal disease. (Markou). Till date, no study has been conducted assessing the serum hsCRP levels in females of reproductive age group with gingivitis. This study, thus, aims to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.
Read the detailed description
Gingivitis is a highly prevalent chronic bacterial disease in susceptible children, adults and the elderly, persisting for decades in subjects, and is an essential precursor of periodontitis. Several studies have shown periodontitis and subgingival P. gingivalis to be associated with increased C-reactive protein (CRP) levels and CRP has been implicated as a possible mediator of the association between periodontitis and several systemic diseases Limited data are available today addressing detrimental systemic effects of experimental or natural gingivitis as they have been rarely investigated. Results of various studies support the concept that gingivitis leads to systemic inflammation and that the level of systemic inflammatory markers increases proportionately with increase in gingival inflammation. It has also been seen that appropriate dental prophylaxis can also limit systemic markers of inflammation in subjects with natural gingivitis. Sex hormones have long been considered to play an influential role on periodontal tissues, bone turnover rate, wound healing and periodontal disease progression and can influence the cellular proliferation, differentiation and growth of keratinocytes and fibroblasts. Estrogen is mainly responsible for alterations in blood vessels and progesterone stimulates the production of inflammatory mediators. In addition, some micro-organisms found in the human mouth synthesize enzymes needed for steroid synthesis and catabolism. Sex hormones are neither necessary nor sufficient to produce gingival changes by themselves. However, they may alter periodontal tissue responses to microbial plaque and thus indirectly contribute to periodontal disease. (Markou). Till date, no study has been conducted assessing the serum hsCRP levels in females of reproductive age group with gingivitis. This study, thus, aims to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.RESEARCH QUESTION What is the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis?
- P -population-systemically healthy women,18-40 years of age having gingivitis.
- I-intervention- Scaling
- C -control/comparison- before and after scaling among systemically healthy women with gingivitis and also with systemically healthy women with healthy periodontium
- O -outcome- plaque index (PI), gingival index (GI), Bleeding on probing (BOP) and serum hsCRP levels
- T- time frame- 6 months
FINER
- F- feasibility- all the facilities required are present in the department.
- I-interesting-impact of scaling on systemic inflammation and periodontal status in women of reproductive age with gingivitis
- N-novelty- very little evidence available
- E-ethical-no ethical issues
- R-relevant-results of the study can help in further strengthening the link between local inflammatory burden and systemic inflammation by observing the effect of scaling on periodontium and systemic markers of inflammation and formulating recommendations for early periodontal care of the patients.
AIM - to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.
OBJECTIVES - PRIMARY OBJECTIVES
- Comparative evaluation of periodontal parameters [plaque index (PI),gingival index (GI), Bleeding on probing (BOP) ] and high sensitivity C reactive protein (hsCRP) levels in systemically healthy women having gingivitis before and after scaling.
- Comparative evaluation of periodontal parameters [plaque index (PI),gingival index (GI), Bleeding on probing (BOP) ] and high sensitivity C reactive protein (hsCRP) levels among systemically healthy women having gingivitis and systemically healthy women with healthy periodontium.
- To assess the association and correlation of periodontal parameters, anthropometric parameters and hsCRP levels in all patients.
SECONDARY OBJECTIVES
- Comparative evaluation of Probing Depth (PD), Clinical attachment level (CAL)(in patients with reduced periodontium), anthropometric parameters of patients in both groups.
- To compare and evaluate self-reported oral health quality of life questionnaire by the patients of both groups.
METHODOLOGY All the participants will be age and BMI matched. The present Randomized Controlled Trial will include 60 systemically healthy women in 2 groups.
Test group, n=30, systemically healthy women having gingivitis will receive oral hygiene instructions (OHI) and Scaling.
Control group, n=30, systemically healthy women having healthy periodontium will be assessed for hsCRP.
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 also at 6 months in test group.
INTERVENTION- Scaling will be done with mechanical instruments and ultrasonic scalers at baseline. Oral hygiene instructions will be given verbally and brushing method will be demonstrated using a cast and a toothbrush.
- Conditions
- Gingivitis
- Being tested
- SCALING
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCALINGProcedure or surgery
SCALING WILL BE DONE AT BASELINE IN TEST GROUP.
| Study group | Role | What they receive |
|---|---|---|
| systemically healthy females with gingivitis | Experimental | scaling will be done at baseline Receives: Procedure: SCALING |
| systemically and periodontally healthy females | No intervention | data will be recorded at baseline and no intervention will be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding on probing
bleeding on probing will be measured on 6 sites per tooth in all the teeth
Measured: 6 months
gingival index
gingival index will be measured on 4 sites per tooth in all the teeth
Measured: 6 months
plaque index
plaque index will be measured on 4 sites per tooth in all the teeth
Measured: 6 months
serum high sensitivity c reactive protein
serum high sensitivity C reactive protein will be measured at baseline and at 6 months
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 posted6 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richa Verma, BDS, Principal investigator, Post Graduate Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639608
- Sponsor's protocol ID
- richa perio 2
- Status last verified
- Nov 2022
- First submitted
- 26 Nov 2022
- Last updated
- 6 Dec 2022
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF SCALING ON SERUM hsCRP LEVELS AND PERIODONTAL PARAMETERS IN SYSTEMICALLY HEALTHY WOMEN OF REPRODUCTIVE AGE GROUP WITH GINGIVITIS: AN INTERVENTIONAL STUDY
- ClinicalTrials.gov ID
- NCT05639608
- Acronym / sponsor ID
- richa perio 2
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 6 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.
Gingivitis is a highly prevalent chronic bacterial disease in susceptible children, adults and the elderly, persisting for decades in subjects, and is an essential precursor of periodontitis. Several studies have shown periodontitis and subgingival P. gingivalis to be associated with increased C-reactive protein (CRP) levels and CRP has been implicated as a possible mediator of the association between periodontitis and several systemic diseases Limited data are available today addressing detrimental systemic effects of experimental or natural gingivitis as they have been rarely investigated. Results of various studies support the concept that gingivitis leads to systemic inflammation and that the level of systemic inflammatory markers increases proportionately with increase in gingival inflammation. It has also been seen that appropriate dental prophylaxis can also limit systemic markers of inflammation in subjects with natural gingivitis. Sex hormones have long been considered to play an influential role on periodontal tissues, bone turnover rate, wound healing and periodontal disease progression and can influence the cellular proliferation, differentiation and growth of keratinocytes and fibroblasts. Estrogen is mainly responsible for alterations in blood vessels and progesterone stimulates the production of inflammatory mediators. In addition, some micro-organisms found in the human mouth synthesize enzymes needed for steroid synthesis and catabolism. Sex hormones are neither necessary nor sufficient to produce gingival changes by themselves. However, they may alter periodontal tissue responses to microbial plaque and thus indirectly contribute to periodontal disease. (Markou). Till date, no study has been conducted assessing the serum hsCRP levels in females of reproductive age group with gingivitis. This study, thus, aims to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.
Detailed description
Gingivitis is a highly prevalent chronic bacterial disease in susceptible children, adults and the elderly, persisting for decades in subjects, and is an essential precursor of periodontitis. Several studies have shown periodontitis and subgingival P. gingivalis to be associated with increased C-reactive protein (CRP) levels and CRP has been implicated as a possible mediator of the association between periodontitis and several systemic diseases Limited data are available today addressing detrimental systemic effects of experimental or natural gingivitis as they have been rarely investigated. Results of various studies support the concept that gingivitis leads to systemic inflammation and that the level of systemic inflammatory markers increases proportionately with increase in gingival inflammation. It has also been seen that appropriate dental prophylaxis can also limit systemic markers of inflammation in subjects with natural gingivitis. Sex hormones have long been considered to play an influential role on periodontal tissues, bone turnover rate, wound healing and periodontal disease progression and can influence the cellular proliferation, differentiation and growth of keratinocytes and fibroblasts. Estrogen is mainly responsible for alterations in blood vessels and progesterone stimulates the production of inflammatory mediators. In addition, some micro-organisms found in the human mouth synthesize enzymes needed for steroid synthesis and catabolism. Sex hormones are neither necessary nor sufficient to produce gingival changes by themselves. However, they may alter periodontal tissue responses to microbial plaque and thus indirectly contribute to periodontal disease. (Markou). Till date, no study has been conducted assessing the serum hsCRP levels in females of reproductive age group with gingivitis. This study, thus, aims to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.RESEARCH QUESTION What is the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis?
- P -population-systemically healthy women,18-40 years of age having gingivitis.
- I-intervention- Scaling
- C -control/comparison- before and after scaling among systemically healthy women with gingivitis and also with systemically healthy women with healthy periodontium
- O -outcome- plaque index (PI), gingival index (GI), Bleeding on probing (BOP) and serum hsCRP levels
- T- time frame- 6 months
FINER
- F- feasibility- all the facilities required are present in the department.
- I-interesting-impact of scaling on systemic inflammation and periodontal status in women of reproductive age with gingivitis
- N-novelty- very little evidence available
- E-ethical-no ethical issues
- R-relevant-results of the study can help in further strengthening the link between local inflammatory burden and systemic inflammation by observing the effect of scaling on periodontium and systemic markers of inflammation and formulating recommendations for early periodontal care of the patients.
AIM - to assess the effect of scaling on serum hsCRP levels and periodontal parameters in systemically healthy women of reproductive age group with gingivitis.
OBJECTIVES - PRIMARY OBJECTIVES
- Comparative evaluation of periodontal parameters [plaque index (PI),gingival index (GI), Bleeding on probing (BOP) ] and high sensitivity C reactive protein (hsCRP) levels in systemically healthy women having gingivitis before and after scaling.
- Comparative evaluation of periodontal parameters [plaque index (PI),gingival index (GI), Bleeding on probing (BOP) ] and high sensitivity C reactive protein (hsCRP) levels among systemically healthy women having gingivitis and systemically healthy women with healthy periodontium.
- To assess the association and correlation of periodontal parameters, anthropometric parameters and hsCRP levels in all patients.
SECONDARY OBJECTIVES
- Comparative evaluation of Probing Depth (PD), Clinical attachment level (CAL)(in patients with reduced periodontium), anthropometric parameters of patients in both groups.
- To compare and evaluate self-reported oral health quality of life questionnaire by the patients of both groups.
METHODOLOGY All the participants will be age and BMI matched. The present Randomized Controlled Trial will include 60 systemically healthy women in 2 groups.
Test group, n=30, systemically healthy women having gingivitis will receive oral hygiene instructions (OHI) and Scaling.
Control group, n=30, systemically healthy women having healthy periodontium will be assessed for hsCRP.
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 also at 6 months in test group.
INTERVENTION- Scaling will be done with mechanical instruments and ultrasonic scalers at baseline. Oral hygiene instructions will be given verbally and brushing method will be demonstrated using a cast and a toothbrush.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemically healthy females with gingivitis | Experimental | Procedure: SCALINGscaling will be done at baseline |
| systemically and periodontally healthy females | No intervention | –data will be recorded at baseline and no intervention will be done |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- females of reproductive age group (18-40 yrs)
- BMI (18.5 - 24.9)
- presence of ≥20 natural teeth
- Healthy periodontium (for control group) defined as bleeding on probing at < 10% of sites, with pockets ≤3 mm, no probing attachment loss and no radiologic bone loss.
- Gingivitis (17) (for test group) Gingivitis (intact periodontium) is defined as bleeding on probing at ≥ 10% of sites, with pockets ≤3 mm, no probing attachment loss and no radiologic bone loss.
Key exclusion criteria (6 listed)
- 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 years
- smokers and alcoholics
- history of systemic antibiotics or oral contraceptives usage within last 3 months
- periapical pathology or oral inflammatory conditions other than gingivitis.
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 |
|---|---|---|
| SCALINGSCALING WILL BE DONE AT BASELINE IN TEST GROUP. | Procedure or surgery | systemically healthy females with gingivitis |
Primary outcome
bleeding on probing
Time frame: 6 months
bleeding on probing will be measured on 6 sites per tooth in all the teeth
gingival index
Time frame: 6 months
gingival index will be measured on 4 sites per tooth in all the teeth
plaque index
Time frame: 6 months
plaque index will be measured on 4 sites per tooth in all the teeth
serum high sensitivity c reactive protein
Time frame: 6 months
serum high sensitivity C reactive protein will be measured at baseline and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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, BDS principal investigator
Post Graduate Institute of Dental Sciences
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 in people with Gingivitis, 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 7 inclusion and 6 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 6 Dec 2022. 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?
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 ext. 213876, drshikhatewari@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 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 6 Dec 2022.