Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane
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|ClinicalTrials.gov Identifier: NCT01900964|
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Clinical Efficacy||Procedure: PTFE membrane Procedure: Collagen membrane||Not Applicable|
Patient Selection 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 :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable vs. a Collagen Membrane With an Intrasocket Mineralized Cancellous Allograft Plus a Facial Overlay Bovine Xenograft.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Active Comparator: PTFE membrane
A non-resorbable PTFE (polytetrafluoroethylene) membrane will be used as a positive control treatment.
Procedure: PTFE membrane
The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.
Experimental: Collagen membrane
A resorbable collagen membrane will be used in the test group.
Procedure: Collagen membrane
A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.
- Crestal ridge width [ Time Frame: Time 4 months ]The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination.
- Percent vital bone [ Time Frame: Time 4 months ]A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site.
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): NCT01900964
|United States, Kentucky|
|Graduate Periodontics Clinic, University of Louisville|
|Louisvile, Kentucky, United States, 40202|
|Principal Investigator:||Henry Greenwell, DMD||University of Louisville|