search
Back to results

Ridge Preservation Comparing the Healing With or Without a Barrier Membrane

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
United States
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 focused on measuring Regeneration, Bone regeneration, Grafting, Bone, Allograft, Xenograft

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. Patients who need prophylactic antibiotics
  7. Previous head and neck radiation therapy.
  8. Chemotherapy in the previous 12 months.
  9. Patients on long term NSAID or steroid therapy.
  10. Pregnant patients.

Sites / Locations

  • Graduate Periodontics Clinic University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ridge preservation membrane

Ridge preservation no membrane

Arm Description

Positive control Patients will receive ridge preservation intrasocket allograft and overlay xenograft resorbable with membrane

test patients will receive ridge preservation intrasocket allograft and overlay xenograft with no membrane

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 9, 2016
Last Updated
September 8, 2020
Sponsor
University of Louisville
search

1. Study Identification

Unique Protocol Identification Number
NCT02798887
Brief Title
Ridge Preservation Comparing the Healing With or Without a Barrier Membrane
Official Title
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 24, 2016 (Actual)
Primary Completion Date
May 18, 2017 (Actual)
Study Completion Date
May 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
Detailed Description
Thirty patients will be treated using the principles of bone grafting for ridge preservation. Fifteen test patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft without a membrane where only the exposed intrasocket allograft will be covered with a piece of Alloderm GBR. The positive control group of fifteen patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR membrane. 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
Keywords
Regeneration, Bone regeneration, Grafting, Bone, Allograft, Xenograft

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 membrane
Arm Type
Experimental
Arm Description
Positive control Patients will receive ridge preservation intrasocket allograft and overlay xenograft resorbable with membrane
Arm Title
Ridge preservation no membrane
Arm Type
Experimental
Arm Description
test patients will receive ridge preservation intrasocket allograft and overlay xenograft with no membrane
Intervention Type
Procedure
Intervention Name(s)
Ridge preservation
Intervention Description
Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane
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. Patients who need prophylactic antibiotics Previous head and neck radiation therapy. Chemotherapy in the previous 12 months. Patients on long term NSAID or steroid therapy. Pregnant patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Greenwell, DMD, MSD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Graduate Periodontics Clinic University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ridge Preservation Comparing the Healing With or Without a Barrier Membrane

We'll reach out to this number within 24 hrs