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

Chronic Periodontitis Clinical Trial

— ETCSNSGD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930356
• Other study ID #: D149206028
• Status: Completed
• Phase: N/A
• First received: October 10, 2016
• Last updated: October 10, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No