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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NSPT
Scaling and root planing
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    NSPT-Test group

    Scaling and root planing-Control group

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    October 10, 2016
    Last Updated
    October 10, 2016
    Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02930356
    Brief Title
    Effect of Tooth Cleaning in Smokers and Non Smokers With Gum Disease.
    Acronym
    ETCSNSGD
    Official Title
    Effects of Nonsurgical Periodontal Therapy on Plasma Hepatocyte Growth Factor Levels in Smokers and Non Smokers With Chronic Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NSPT-Test group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Scaling and root planing-Control group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    NSPT
    Intervention Description
    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
    Intervention Name(s)
    Scaling and root planing
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Primary outcome of the study was to measure plasma heaptocyte growth factor level
    Description
    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
    Time Frame
    baseline, 3 months
    Secondary Outcome Measure Information:
    Title
    gingival index
    Description
    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
    Time Frame
    baseline and 3 months
    Title
    periodontal index
    Description
    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
    Time Frame
    baseline and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr.Veerendranath R Panthula, MDS
    Organizational Affiliation
    Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25389376
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21976839
    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.
    Results Reference
    background

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

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