Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2013-09-30
2014-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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With primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.
With primary closure
A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.
Without primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.
Without primary closure
A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will not be primarily closed over the membrane.
Interventions
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With primary closure
A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.
Without primary closure
A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will not be primarily closed over the membrane.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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University of Louisville
OTHER
Responsible Party
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Henry Greenwell
Professor
Principal Investigators
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Henry Greenwell, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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Graduate Periodontics Clinic University of Louisville
Louisville, Kentucky, United States
Countries
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Other Identifiers
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13.0331
Identifier Type: -
Identifier Source: org_study_id