Effect of Periodontal Treatment on Salivary Biomarkers

June 9, 2014 updated by: Eran Front, The Baruch Padeh Medical Center, Poriya

Effect of Periodontal Treatment on Salivary Biomarkers.

The investigators plan to recruit 40 healthy patients referred to the unit of Periodontology, diagnosed with generalized moderate - severe chronic periodontitis.

treatment will include 4 - 6 sessions of scaling + root planning, oral hygiene instructions and motivation.

Whole saliva will be collected at intake and 8 - 14 weeks post periodontal treatment.

Saliva will be analyzed for trans locator protein. Study hypothesis: Periodontal treatment has an affect on saliva components.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy patients
  • moderate - sever chronic periodontitis

Exclusion Criteria:

  • systemic disease
  • pregnancy
  • subjects under the age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: periodontal treatmnent
Procedure: periodontal treatment - scaling and root planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole saliva & translocator protein (TSPO)
Time Frame: Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)
Change in whole saliva & translocator protein (TSPO) post periodontal treatment
Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level)
Time Frame: Intake 8 - 12 weeks post periodontal treatment (scaling & root planning)
periodontal probing depth, bleeding on probing and clinical attachment level.
Intake 8 - 12 weeks post periodontal treatment (scaling & root planning)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-1476.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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