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

NCT05639608 | Unknown DMC

• 1 other identifier: richa perio 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (4)

• bleeding on probing

  bleeding on probing will be measured on 6 sites per tooth in all the teeth

  6 months

• gingival index

  gingival index will be measured on 4 sites per tooth in all the teeth

  6 months

• plaque index

  plaque index will be measured on 4 sites per tooth in all the teeth

  6 months

• serum high sensitivity c reactive protein

  serum high sensitivity C reactive protein will be measured at baseline and at 6 months

  6 months

Study Arms (2)

systemically healthy females with gingivitis

EXPERIMENTAL

scaling will be done at baseline

Procedure: SCALING

systemically and periodontally healthy females

NO INTERVENTION

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

Interventions

SCALING PROCEDURE

SCALING WILL BE DONE AT BASELINE IN TEST GROUP.

systemically healthy females with gingivitis

Eligibility Criteria

• Age: 15 Years - 40 Years
• Gender Eligibility Details: females of reproductive age group shall be recruited
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (2)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

Shikha Tewari

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Richa Verma, BDS

  Post Graduate Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shikha tewari, MDS

CONTACT

01262; drshikhatewari@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 6, 2022
• Study Start: December 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

IN (2)