Ridge Preservation Comparing 2 Membranes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01905280|
Recruitment Status : Completed
First Posted : July 23, 2013
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment|
|Alveolar Ridge Deficiency||Procedure: Non-resorbable membrane Procedure: Acellular dermal matrix|
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|
|Primary Completion Date :||July 2014|
|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.
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): NCT01905280
|United States, Kentucky|
|Graduate Periodontics Clinic University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Henry Greenwell, DMD||University of Louisville|