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Clinical Trials/CTRI/2021/08/035791
CTRI/2021/08/035791Not yet recruitingPhase 1

Evaluation Of C-Reactive Protein Levels And Blood Parameters in Chronic Periodontitis patients following non-surgical periodontal therapy: A Clinico-biochemical study

Fouzia Imran1 site in 1 country49 target enrollmentStarted: August 25, 2021Last updated:

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Sponsor
Enrollment
49
Locations
1
Primary Endpoint
To show the importance of C-Reactive protein in the maintenance of oral hygiene and to discuss the importance of maintenance of oral hygiene

Study Overview

Brief Summary

Chronic periodontitis is a disease characterized by an intense inflammatory infiltrate associated with irreversible loss of alveolar bone and connective tissue attachment in the periodontium which ultimately results in the loss of teeth. The mechanism underlying this destructive process involves both direct tissue damage resulting from plaque bacterial products and indirect damage through bacterial induction in the host cells by an activation of inflammatory mediators such as cytokines, prostaglandins and acute phase proteins. In response to bacteria or endotoxins derived from these periodontal pathogens, several acute phase proteins orchestrate the inflammatory cascade to bring about a balance between host and inflammatory stimuli. One consequence of these inflammatory reactions has been the elevated levels of various acute phase proteins in the serum, plasma, saliva and in gingival crevicular fluid. These acute phase response are initiated by activation of local macrophages and other cells such as fibroblast and endothelial cells, leading to the release of mediators such as Tumor necrosis factor (TNF-α), Interleukin-6 (IL-6) and Interleukin-1β (IL-1β) which in turn stimulate these proteins causing systemic changes.

C-reactive protein (CRP) is a very strong acute phase protein produced in the liver and circulates in the blood. It was discovered by Tillett and Francis laboratory in 1930. It is a systemic marker of inflammation induced by various inflammatory stimuli such as trauma, infection and hypoxia. CRP and other acute phase proteins are usually present at low levels in plasma, but may arise dramatically within 72 hours of injury or with infection. It receives much attention as their level guides decision for diagnosis, monitoring and therapy for inflammatory process and associated diseases. It was proved to be a significant predictor of future cardiovascular events.

The main purpose of this study is to compare and to evaluate the serum level of hs-CRP and CBC in moderate and advanced chronic periodontitis patients before and after nonsurgical periodontal treatment correlated with clinical findings.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
15.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • For control group, the participants with at least 20 natural teeth and probing pocket depth of 2–3 mm with no attachment loss and bleeding on probing with <20% sites.
  • For the study group, the participants had to have five qualifying sites in two quadrants with a minimum of two affected teeth in each quadrant with each site having probing depth ≥5 mm, clinical attachment loss (CAL) ≥3 mm, and bleeding on probing.
  • Patients who consented to willingly follow the endorsed plaque control and follow-up routine.

Exclusion Criteria

  • Medically compromised patients with presence of any systematic disease
  • Pregnant & Lactating women
  • Patients taking any medication for the past 3 months.
  • Patients who are not maintaining their oral hygiene
  • Current smokers.

Outcomes

Primary Outcomes

To show the importance of C-Reactive protein in the maintenance of oral hygiene and to discuss the importance of maintenance of oral hygiene

Time Frame: pre-op,7 days and 1month following therapy

Secondary Outcomes

  • To show and study on the importance on C-Reactive protein in chronic periodontitis patients(pre-op,7days and 1 month following therapy)

Investigators

Sponsor
Fouzia Imran
Sponsor Class
Other [Self Sponsoring]

Study Sites (1)

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