Ridge Preservation Comparing 2 Membranes
|ClinicalTrials.gov Identifier: NCT01905280|
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alveolar Ridge Deficiency||Procedure: Non-resorbable membrane Procedure: Acellular dermal matrix||Not Applicable|
30 patients will be selected that meet the following criteria:
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy male or female who is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics.
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
- Pregnant patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Acellular dermal matrix
A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane.
Procedure: Acellular dermal matrix
The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.
Other Name: Acellular dermal matrix allograft, Alloderm
Active Comparator: Non-resorbable membrane
A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane.
Procedure: Non-resorbable membrane
The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.
Other Name: PTFE or Cytoplast
- Crestal ridge width [ Time Frame: 4 months ]The width of the ridge at the crest will be measured with a digital caliper.
- Percent vital bone [ Time Frame: 4 months ]Percent vital bone at the graft site will be determined from a trephine core sample.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905280
|United States, Kentucky|
|Graduate Periodontics Clinic University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Henry Greenwell, DMD||University of Louisville|