ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02152215
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

May 21, 2014
June 2, 2014
December 8, 2016
July 2014
June 2015   (Final data collection date for primary outcome measure)
Change in crestal osseous width [ Time Frame: 4 month ]
Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.
Same as current
Complete list of historical versions of study NCT02152215 on ClinicalTrials.gov Archive Site
Percent osseous tissue [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
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
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.
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).
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Ridge Preservation
  • 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.
    Other Name: Alloderm GBR
  • 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
    Other Name: Guidor
  • Active Comparator: Acellular dermal matrix membrane
    An acellular dermal matrix membrane will be used as a barrier between the osseous graft and the soft tissue flap.
    Intervention: Procedure: Acellular dermal matrix membrane
  • Experimental: Polylactic acid membrane
    A polylactic acid membrane will be used as a barrier between the osseous graft and the soft tissue flap.
    Intervention: Procedure: Polylactic acid membrane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
30
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02152215
14.0430
No
Not Provided
Not Provided
Henry Greenwell, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Henry Greenwell, DMD, MSD University of Louisville School of Dentistry
University of Louisville
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP