Ridge Augmentation Without Primary Closure
|ClinicalTrials.gov Identifier: NCT01901783|
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alveolar Ridge Augmentation||Procedure: With primary closure Procedure: Without primary closure||Not Applicable|
A maximum of 30 patients will be selected that meet the following 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: With primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.
Procedure: 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.
Other Name: Primary soft tissue closure over the membrane.
Experimental: Without primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.
Procedure: 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 Name: No primary soft tissue closure over the membrane.
- Crestal ridge width [ Time Frame: 4 months ]The ridge width at the crest will be compared between the two treatment groups.
- Percent vital bone [ Time Frame: 4 months ]The percent vital bone will be compared between the two treatment groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901783
|United States, Kentucky|
|Graduate Periodontics Clinic University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Henry Greenwell, DMD||University of Louisville|