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

NCT ID: NCT02930356

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NSPT

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Scaling and root planing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

OTHER

Sponsor Role: lead

Responsible Party

C.BHARGAVI

PG STUDENT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr.Veerendranath R Panthula, MDS

Role: STUDY_DIRECTOR

Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre

References

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.

Reference Type: BACKGROUND

PMID: 25389376 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21976839 (View on PubMed)

Other Identifiers

D149206028

Identifier Type: -

Identifier Source: org_study_id