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Clinical Trials/NCT01901783
NCT01901783
Completed
Not Applicable

Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure

University of Louisville1 site in 1 country18 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Ridge Augmentation
Sponsor
University of Louisville
Enrollment
18
Locations
1
Primary Endpoint
Crestal ridge width
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

Detailed Description

A maximum of 30 patients will be selected that meet the following criteria: Inclusion Criteria 1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth. 2. Healthy person that is at least 18 years old. 3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria 1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment. 2. Previous head and neck radiation or chemotherapy within the previous 12 months. 3. Patients with known allergy to any of the materials that will be used in the study. 4. Smokers. 5. Patients who need prophylactic antibiotics prior to dental procedures. 6. Patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any IV biosphosphonates. 7. Patients who are pregnant.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
June 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

  • At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
  • Healthy person that is at least 18 years old.
  • Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

  • Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
  • Previous head and neck radiation or chemotherapy within the previous 12 months.
  • Patients with known allergy to any of the materials that will be used in the study.
  • Patients who need prophylactic antibiotics prior to dental procedures.
  • Patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any IV biosphosphonates.
  • Patients who are pregnant.

Outcomes

Primary Outcomes

Crestal ridge width

Time Frame: 4 months

The ridge width at the crest will be compared between the two treatment groups.

Secondary Outcomes

  • Percent vital bone(4 months)

Study Sites (1)

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