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

NCT02152215 | Completed Phase 4

• 1 other identifier: 14.0430
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Ridge Preservation

Outcome Measures

Primary Outcomes (1)

• Change in crestal osseous width

  Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.

  4 month

Secondary Outcomes (1)

• Percent osseous tissue

  4 months post-treatment

Study Arms (2)

Acellular dermal matrix membrane

ACTIVE COMPARATOR

An acellular dermal matrix membrane will be used as a barrier between the osseous graft and the soft tissue flap.

Procedure: Acellular dermal matrix membrane

Polylactic acid membrane

EXPERIMENTAL

A polylactic acid membrane will be used as a barrier between the osseous graft and the soft tissue flap.

Procedure: Polylactic acid membrane

Interventions

Acellular dermal matrix membrane PROCEDURE

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.

Also known as: Alloderm GBR

Acellular dermal matrix membrane

Polylactic acid membrane PROCEDURE

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

Also known as: Guidor

Polylactic acid membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Graduate Periodontics Clinic, School of Dentistry, University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Guidor

Study Officials

• Henry Greenwell, DMD, MSD

  University of Louisville School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Graduate Periodontics

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: June 2, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)