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Clinical Trials/NCT01905280
NCT01905280
Completed
Not Applicable

Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.

University of Louisville1 site in 1 country24 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Ridge Deficiency
Sponsor
University of Louisville
Enrollment
24
Locations
1
Primary Endpoint
Crestal ridge width
Status
Completed
Last Updated
9 years ago

Overview

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.

Detailed Description

30 patients will be selected that meet the following criteria: Inclusion Criteria 1. 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. 2. Healthy male or female who is at least 18 years old. 3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria 1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. 2. Presence or history of osteonecrosis of jaws. 3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. 4. Patients who have been treated with oral bisphosphonates for more than three years. 5. Patients with an allergy to any material or medication used in the study. 6. Patients who need prophylactic antibiotics. 7. Previous head and neck radiation therapy. 8. Chemotherapy in the previous 12 months. 9. Patients on long term NSAID or steroid therapy. 10. Pregnant patients.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
July 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Henry Greenwell

Professor

University of Louisville

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.

Outcomes

Primary Outcomes

Crestal ridge width

Time Frame: 4 months

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

Secondary Outcomes

  • Percent vital bone(4 months)

Study Sites (1)

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