Ridge Augmentation Without Primary Closure
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|