NCT02152215

Ridge Preservation Comparing a Polylactic Acid Membrane vs. an Acellular Dermal Matrix Membrane

Ridge Preservation Comparing the Clinical and Histologic Healing of a Bioabsorbable Membrane Made of Polylactic Acid and a Citric Acid Ester vs. an Acellular Dermal Matrix Allograft GBR

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and resorbable membranes to determine if either provides a significant therapeutic advantage.

Detailed description

The control subjects will receive a bone graft in the extraction socket, plus an additional bone graft on the outside socket wall covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester. The test subjects will receive same type and technique of bone graft with a the acellular dermal matrix membrane to cover the bone graft. The membrane the patients receive will be randomly assigned using a coin toss: heads will be assigned to the test group while tails will be assigned for controls. The objective is to determine if at 4 months the width and height of the jaw bone and also the soft tissue thickness where the tooth was extracted has increased, decreased or remained the same. Also the amount of patients own newly formed bone will be determined by microscopic examination of a core of jaw bone that will be obtained from the site of implant placement immediately before the implant is placed (the implant is not considered part of the study).

Conditions

• Ridge Preservation

Interventions

Type	Name	Description
PROCEDURE	Acellular dermal matrix membrane	The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive an intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft covered by an acellular dermal matrix, composed of human connective tissue matrix.
PROCEDURE	Polylactic acid membrane	The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft, covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-06-02
• Last updated: 2016-12-08

Locations

1 site across 1 country: United States