Clinical trial NCT02152215: Ridge Preservation Comparing a Polylactic Acid Membrane vs. an Acellular Dermal Matrix Membrane
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ridge Preservation
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in crestal osseous width
timeFrame: 4 month
Secondary outcomes:
measure: Percent osseous tissue
timeFrame: 4 months post-treatment
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics Clinic, School of Dentistry, University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville School of Dentistry
name: Henry Greenwell, DMD, MSD
role: PRINCIPAL_INVESTIGATOR
References: