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Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ridge Preservation
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

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

Inclusion Criteria:

  1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
  2. Healthy male or female who is at least 18 years old.
  3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

  1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
  2. Presence or history of osteonecrosis of jaws.
  3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
  4. Patients who have been treated with oral bisphosphonates for more than three years.
  5. Patients with an allergy to any material or medication used in the study.
  6. Previous head and neck radiation therapy.
  7. Chemotherapy in the previous 12 months.
  8. Pregnant patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Ridge preservation Flap

    Ridge preservation Flapless

    Arm Description

    The flap procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal.

    The test will be a flapless technique with tunneling and an intramucosal vertical incision on the buccal.

    Outcomes

    Primary Outcome Measures

    Change in post-extraction site to 4 month change in crestal osseous width
    Changes in post-extraction to 4 month change in ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.

    Secondary Outcome Measures

    Change in Soft tissue thickness
    Soft tissue thickness measurements taken with a #40 endodontic reamer.
    Percent osseous tissue
    A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.

    Full Information

    First Posted
    June 19, 2015
    Last Updated
    December 6, 2016
    Sponsor
    University of Louisville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02487758
    Brief Title
    Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
    Official Title
    Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Louisville

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
    Detailed Description
    Thirty patients will be treated using the principles of guided bone regeneration and ridge preservation. Fifteen test patients will receive the flapless technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. The positive control group of fifteen patients will receive the flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Jaw, Edentulous, Partially

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ridge preservation Flap
    Arm Type
    Experimental
    Arm Description
    The flap procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal.
    Arm Title
    Ridge preservation Flapless
    Arm Type
    Experimental
    Arm Description
    The test will be a flapless technique with tunneling and an intramucosal vertical incision on the buccal.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ridge Preservation
    Intervention Description
    Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
    Primary Outcome Measure Information:
    Title
    Change in post-extraction site to 4 month change in crestal osseous width
    Description
    Changes in post-extraction to 4 month change in ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Change in Soft tissue thickness
    Description
    Soft tissue thickness measurements taken with a #40 endodontic reamer.
    Time Frame
    4 months
    Title
    Percent osseous tissue
    Description
    A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth. Healthy male or female who is at least 18 years old. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria: Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. Presence or history of osteonecrosis of jaws. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. Patients who have been treated with oral bisphosphonates for more than three years. Patients with an allergy to any material or medication used in the study. Previous head and neck radiation therapy. Chemotherapy in the previous 12 months. Pregnant patients.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Henry Greenwell, DMD
    Organizational Affiliation
    University of Louisville
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

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