Ridge Preservation Comparing 2 Membranes

NCT01905280 | Completed

• 1 other identifier: 13.0330
• Study Type: interventional
• Target: 24
• 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 a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.

Conditions

Alveolar Ridge Deficiency

Keywords

allograft; acellular dermal matrix; alveolar ridge

Outcome Measures

Primary Outcomes (1)

• Crestal ridge width

  The width of the ridge at the crest will be measured with a digital caliper.

  4 months

Secondary Outcomes (1)

• Percent vital bone

  4 months

Study Arms (2)

Acellular dermal matrix

EXPERIMENTAL

A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane.

Procedure: Acellular dermal matrix

Non-resorbable membrane

ACTIVE COMPARATOR

A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane.

Procedure: Non-resorbable membrane

Interventions

Non-resorbable membrane PROCEDURE

The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.

Also known as: PTFE or Cytoplast

Non-resorbable membrane

Acellular dermal matrix PROCEDURE

The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.

Also known as: Acellular dermal matrix allograft, Alloderm

Acellular dermal matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Polytetrafluoroethylene; Alloderm

Intervention Hierarchy (Ancestors)

Fluorocarbon Polymers; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Henry Greenwell, DMD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 23, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)