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Clinical Trials/NCT01901783
NCT01901783CompletedNot 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 Louisville2 sites in 1 country18 target enrollmentStarted: September 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Crestal ridge width
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henry Greenwell

Professor

University of Louisville

Study Sites (2)

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