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Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?

Primary Purpose

Impacted Third Molar Tooth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Geistlich Bio Oss
Sponsored by
The Baruch Padeh Medical Center, Poriya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Impacted Third Molar Tooth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Bilateral impacted 3rd molars.
  • Healthy individuals

Exclusion Criteria:

  • Smokers
  • Alcohol abusers
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    3rd molar

    Arm Description

    Drug: Geistlich Bio Oss

    Outcomes

    Primary Outcome Measures

    Mobility (Scale 0,1,2,3), change is being assessed.
    Mobility will be assessed in the intervals mentioned above, and compared over time.
    Pocket Depth (mm), change is being assessed.
    Pocket depth will be assessed in the intervals mentioned above, and compared over time.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2016
    Last Updated
    April 25, 2016
    Sponsor
    The Baruch Padeh Medical Center, Poriya
    Collaborators
    Geistlich Pharma AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02753439
    Brief Title
    Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?
    Official Title
    Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    February 2018 (Anticipated)
    Study Completion Date
    February 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Baruch Padeh Medical Center, Poriya
    Collaborators
    Geistlich Pharma AG

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.
    Detailed Description
    40 patients will undergo bilateral 3rd molar extractions, in each patient one side would be augmented by a "Bio-Oss" xenograft. Post operative, periodontal parameters such as pocket depth and mobility will be evaluated and compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impacted Third Molar Tooth

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    3rd molar
    Arm Type
    Experimental
    Arm Description
    Drug: Geistlich Bio Oss
    Intervention Type
    Drug
    Intervention Name(s)
    Geistlich Bio Oss
    Other Intervention Name(s)
    Bone Support
    Intervention Description
    Extraction of Impacted 3rd Molars,
    Primary Outcome Measure Information:
    Title
    Mobility (Scale 0,1,2,3), change is being assessed.
    Description
    Mobility will be assessed in the intervals mentioned above, and compared over time.
    Time Frame
    Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp
    Title
    Pocket Depth (mm), change is being assessed.
    Description
    Pocket depth will be assessed in the intervals mentioned above, and compared over time.
    Time Frame
    Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Bilateral impacted 3rd molars. Healthy individuals Exclusion Criteria: Smokers Alcohol abusers Pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Extraction of Impacted 3rd Molars, Can Bone Support of the Second Molar be Promoted by a Bio-Oss Graft?

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