Clinical trial NCT05639608: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gingivitis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

1. 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.
2. 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.
3. To assess the association and correlation of periodontal parameters, anthropometric parameters and hsCRP levels in all patients.

SECONDARY OBJECTIVES

1. Comparative evaluation of Probing Depth (PD), Clinical attachment level (CAL)(in patients with reduced periodontium), anthropometric parameters of patients in both groups.
2. 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.

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.

Primary outcomes:
measure: bleeding on probing
timeFrame: 6 months
measure: gingival index
timeFrame: 6 months
measure: plaque index
timeFrame: 6 months
measure: serum high sensitivity c reactive protein
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
city: Rohtak
country: India
facility: Shikha Tewari
state: Haryana
Study officials:
affiliation: Post Graduate Institute of Dental Sciences
name: Richa Verma, BDS
role: PRINCIPAL_INVESTIGATOR
References: