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

Phase 4

Completed

• Conditions: Ridge Preservation
• Interventions: Procedure: Acellular dermal matrix membrane; Procedure: Polylactic acid membrane

• Registration Number: NCT02152215
• Lead Sponsor: University of Louisville

Brief 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).

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Study Start: 2014-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acellular dermal matrix membrane	Acellular dermal matrix membrane	An acellular dermal matrix membrane will be used as a barrier between the osseous graft and the soft tissue flap.
Polylactic acid membrane	Polylactic acid membrane	A polylactic acid membrane will be used as a barrier between the osseous graft and the soft tissue flap.

Primary Outcome Measures

Name	Time	Method
Change in crestal osseous width	4 month	Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.

Secondary Outcome Measures

Name	Time	Method
Percent osseous tissue	4 months post-treatment	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.

Trial Locations

Locations (1)

Graduate Periodontics Clinic, School of Dentistry, University of Louisville; 🇺🇸 Louisville, Kentucky, United States