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EFFECT OF SCALING ON SERUM hsCRP LEVELS AND PERIODONTAL PARAMETERS IN SYSTEMICALLY HEALTHY YOUNG WOMEN WITH GINGIVITIS

Primary Purpose

Gingivitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
SCALING
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Post Graduate Institute of Dental Sciences
  • Shikha Tewari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

systemically healthy females with gingivitis

systemically and periodontally healthy females

Arm Description

scaling will be done at baseline

data will be recorded at baseline and no intervention will be done

Outcomes

Primary Outcome Measures

bleeding on probing
bleeding on probing will be measured on 6 sites per tooth in all the teeth
gingival index
gingival index will be measured on 4 sites per tooth in all the teeth
plaque index
plaque index will be measured on 4 sites per tooth in all the teeth
serum high sensitivity c reactive protein
serum high sensitivity C reactive protein will be measured at baseline and at 6 months

Secondary Outcome Measures

Full Information

First Posted
November 26, 2022
Last Updated
November 26, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05639608
Brief Title
EFFECT OF SCALING ON SERUM hsCRP LEVELS AND PERIODONTAL PARAMETERS IN SYSTEMICALLY HEALTHY YOUNG WOMEN WITH GINGIVITIS
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
systemically healthy females with gingivitis
Arm Type
Experimental
Arm Description
scaling will be done at baseline
Arm Title
systemically and periodontally healthy females
Arm Type
No Intervention
Arm Description
data will be recorded at baseline and no intervention will be done
Intervention Type
Procedure
Intervention Name(s)
SCALING
Intervention Description
SCALING WILL BE DONE AT BASELINE IN TEST GROUP.
Primary Outcome Measure Information:
Title
bleeding on probing
Description
bleeding on probing will be measured on 6 sites per tooth in all the teeth
Time Frame
6 months
Title
gingival index
Description
gingival index will be measured on 4 sites per tooth in all the teeth
Time Frame
6 months
Title
plaque index
Description
plaque index will be measured on 4 sites per tooth in all the teeth
Time Frame
6 months
Title
serum high sensitivity c reactive protein
Description
serum high sensitivity C reactive protein will be measured at baseline and at 6 months
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females of reproductive age group shall be recruited
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shikha tewari, MDS
Phone
01262
Ext
213876
Email
drshikhatewari@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richa Verma, BDS
Organizational Affiliation
Post Graduate Institute of Dental Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shikha Tewari, MDS
Facility Name
Shikha Tewari
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

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EFFECT OF SCALING ON SERUM hsCRP LEVELS AND PERIODONTAL PARAMETERS IN SYSTEMICALLY HEALTHY YOUNG WOMEN WITH GINGIVITIS

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