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Not Yet Recruiting NCT05639608

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

Conditions: Gingivitis

Sex: Female
Ages: 15 Years – 40 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Location: India

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.

Eligibility Criteria

Inclusion Criteria:females of reproductive age group (18-40 yrs)BMI (18.5 - 24.9)presence of ≥20 natural teethHealthy 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 dysfunctionnephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, active cancer within the last past 5 yearssmokers and alcoholicshistory of systemic antibiotics or oral contraceptives usage within last 3 monthsperiapical 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.

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Source: ClinicalTrials.gov (NCT05639608). StuddyBuddy aggregates publicly available trial information.