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Effect of Periodontal Treatment on Salivary Biomarkers

Primary Purpose

Chronic Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
periodontal treatment - scaling and root planning
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy patients
  • moderate - sever chronic periodontitis

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    periodontal treatmnent

    Arm Description

    Outcomes

    Primary Outcome Measures

    Whole saliva & translocator protein (TSPO)
    Change in whole saliva & translocator protein (TSPO) post periodontal treatment

    Secondary Outcome Measures

    Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level)
    periodontal probing depth, bleeding on probing and clinical attachment level.

    Full Information

    First Posted
    May 28, 2014
    Last Updated
    June 9, 2014
    Sponsor
    The Baruch Padeh Medical Center, Poriya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02159781
    Brief Title
    Effect of Periodontal Treatment on Salivary Biomarkers
    Official Title
    Effect of Periodontal Treatment on Salivary Biomarkers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    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
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    periodontal treatmnent
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    periodontal treatment - scaling and root planning
    Primary Outcome Measure Information:
    Title
    Whole saliva & translocator protein (TSPO)
    Description
    Change in whole saliva & translocator protein (TSPO) post periodontal treatment
    Time Frame
    Intake of patients than 8 - 12 weeks after periodontal treatment (scaling & root planning)
    Secondary Outcome Measure Information:
    Title
    Periodontal measurements (periodontal pocket depth, bleeding on probing & clinical attachment level)
    Description
    periodontal probing depth, bleeding on probing and clinical attachment level.
    Time Frame
    Intake 8 - 12 weeks post periodontal treatment (scaling & root planning)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy patients moderate - sever chronic periodontitis Exclusion Criteria: systemic disease pregnancy subjects under the age of 18
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eran Front, DMD
    Phone
    +97246652254
    Email
    efront@poria.health.gov.il

    12. IPD Sharing Statement

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    Effect of Periodontal Treatment on Salivary Biomarkers

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