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

Effects of Nonsurgical Periodontal Therapy on Plasma Hepatocyte Growth Factor Levels in Smokers and Non Smokers With Chronic Periodontitis

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

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Other: NSPT; Other: Scaling and root planing

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NSPT-Test group; 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.	Other: NSPT; NSPT was done by ultrasonic scalers 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 assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.
Experimental: Scaling and root planing-Control group; 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.	Other: Scaling and root planing; Scaling and root planing was done by ultrasonic scalers 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 assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome of the study was to measure plasma heaptocyte growth factor level	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	baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival index	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	baseline and 3 months
periodontal index	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	baseline and 3 months

Collaborators and Investigators

• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Investigators: Study Director: Dr.Veerendranath R Panthula, MDS, Panineeya Mahavidyalaya institute of dental sciences and research centre

Publications and helpful links

General Publications

• Anil S, Vellappally S, Preethanath RS, Mokeem SA, AlMoharib HS, Patil S, Chalisserry EP, Al Kheraif AA. Hepatocyte growth factor levels in the saliva and gingival crevicular fluid in smokers with periodontitis. Dis Markers. 2014;2014:146974. doi: 10.1155/2014/146974. Epub 2014 Oct 15.
• Rudrakshi C, Srinivas N, Mehta DS. A comparative evaluation of hepatocyte growth factor levels in gingival crevicular fluid and saliva and its correlation with clinical parameters in patients with and without chronic periodontitis: A clinico-biochemical study. J Indian Soc Periodontol. 2011 Apr;15(2):147-51. doi: 10.4103/0972-124X.84384.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 12, 2016

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: D149206028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO