NCT02930356

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 10, 2016

Last Update Submit

October 10, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • gingival index

    baseline and 3 months

  • periodontal index

    baseline and 3 months

Study Arms (2)

NSPT-Test group

EXPERIMENTAL

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

Scaling and root planing-Control group

EXPERIMENTAL

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

Interventions

NSPTOTHER

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.

NSPT-Test group

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.

Scaling and root planing-Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 25389376BACKGROUND
  • 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.

    PMID: 21976839BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Dr.Veerendranath R Panthula, MDS

    Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PG STUDENT

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

October 12, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share