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Ridge Preservation Comparing a Flap Versus Flapless Technique

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 with a dental implant where at least one adjacent tooth is present
  2. Study subjects at least 18 years old
  3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.

Exclusion Criteria:

  1. Patients with debilitating systemic disease, or a disease affects the periodontium
  2. Have an allergy to any material or medication used in the study
  3. Require prophylactic antibiotics
  4. Previous head and neck radiation therapy
  5. Chemotherapy in the previous 12 months
  6. Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
  7. Smoked more than one pack of cigarettes per day

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Test

    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, no flap will be reflected.

    Outcomes

    Primary Outcome Measures

    Crestal Horizontal Ridge Width
    Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper.

    Secondary Outcome Measures

    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
    February 12, 2020
    Last Updated
    June 2, 2023
    Sponsor
    University of Louisville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04271423
    Brief Title
    Ridge Preservation Comparing a Flap Versus Flapless Technique
    Official Title
    Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (Actual)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.
    Detailed Description
    Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when 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
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    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
    Test
    Arm Type
    Experimental
    Arm Description
    The test will be a flapless technique, no flap will be reflected.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ridge Preservation
    Intervention Description
    Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.
    Primary Outcome Measure Information:
    Title
    Crestal Horizontal Ridge Width
    Description
    Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper.
    Time Frame
    4 months after surgery
    Secondary Outcome Measure Information:
    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 after surgery

    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 with a dental implant where at least one adjacent tooth is present Study subjects at least 18 years old Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board. Exclusion Criteria: Patients with debilitating systemic disease, or a disease affects the periodontium Have an allergy to any material or medication used in the study Require prophylactic antibiotics Previous head and neck radiation therapy Chemotherapy in the previous 12 months Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy Smoked more than one pack of cigarettes per day
    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

    Plan to Share IPD
    No

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    Ridge Preservation Comparing a Flap Versus Flapless Technique

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