Effect of Tooth Cleaning in Smokers and Non Smokers With Gum Disease.

Not Applicable

Completed

• Conditions: Chronic Periodontitis
• Interventions: Other: NSPT; Other: Scaling and root planing

• Registration Number: NCT02930356
• Lead Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief Summary

This study is intended to measure hepatocyte growth factor levels in smokers and non smokers with periodontitis before and after non surgical periodontal therapy.

Detailed Description

The study was randomised prospective,interventional clinical trial. The sample size for the study was 40 individuals aged between 20 to 60 years,equally divided into two groups.

Group l - smokers with chronic periodontitis (test) group. Group ll - non smokers with chronic periodontitis (controls)

At baseline both the groups were analysed for clinical and biochemical parameters and underwent non surgical periodontal therapy( scaling and root planning). All parameters were reassesed after 3 months.

A total of 40 patients( 20 somkers and 20 non smokers) from the outpatient wing of department of periodontics, Panineeya mahavidyalaya institute of dental sciences and research centre diagnosed with chronic periodontitis and willing to participate in the study.

Clicical parameters included gingival index and periodontal index. Biochmeical parameters included plasma hepatocyte growth factor.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-04
• Study Completion: 2016-06
• Status Verified: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-10
• Last Update Submitted: 2016-10-10
• Study First Posted: 2016-10-12
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• probing depth >4mm
• clinical attachment loss>2mm

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Exclusion Criteria

• patients younger than 20 years and greater than 60 years
• presence of any chronic conditions like diabetes,infections
• antibiotic therapy received preceeding 3 months
• former smokers who had quit the habit of smoking
• patients who already underwent periodontal therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSPT-Test group	NSPT	NSPT was done after administration of pre procedural mouth rinse in the test group (20 smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to asses the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.
Scaling and root planing-Control group	Scaling and root planing	Scaling and root planing was done after administration of pre procedural mouth rinse in the control group (20 non smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to asses the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.

Primary Outcome Measures

Name	Time	Method
Primary outcome of the study was to measure plasma heaptocyte growth factor level	baseline, 3 months	The change in plasma hepatocyte growth factor level was measured at baseline and at the end of 3 months after scaling and root planing.2 ml blood was drawn from the patient to assess the hepatocyte growth factor levels.biochemical analysis was done by ELISA test i.e., blood samples from both smokers and non smokers with chronic periodontitis were taken at baseline and at the end of 3 monthd

Secondary Outcome Measures

Name	Time	Method
gingival index	baseline and 3 months	The secondary outcome of the study is to measure gingival index at baseline and 3 months after scaling and root planing. gingival index was assesed using williams periodontal probe
periodontal index	baseline and 3 months	The secondary outcome of the study is to measure periodontal index at baseline and 3 months after scaling and root planing. periodontal index was assesed using williams periodontal probe