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
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially
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
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
NCT ID
NCT04271423
First Posted
February 12, 2020
Last Updated
June 2, 2023
Sponsor
University of Louisville
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
Learn more about this trial
Ridge Preservation Comparing a Flap Versus Flapless Technique
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