Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane
NCT ID: NCT01900964
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-10-31
2013-11-30
Brief Summary
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Detailed Description
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Inclusion Criteria
1. 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.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria
1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics.
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID or steroid therapy.
10. Pregnant patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PTFE membrane
A non-resorbable PTFE (polytetrafluoroethylene) membrane will be used as a positive control treatment.
PTFE membrane
The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.
Collagen membrane
A resorbable collagen membrane will be used in the test group.
Collagen membrane
A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.
Interventions
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PTFE membrane
The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.
Collagen membrane
A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.
Eligibility Criteria
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Inclusion Criteria
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
\-
Exclusion Criteria
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics.
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID (nonsteroidal anti-inflammatory drug) or steroid therapy.
10. Pregnant patients. -
18 Years
ALL
Yes
Sponsors
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University of Louisville
OTHER
Responsible Party
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Henry Greenwell
Professor
Principal Investigators
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Henry Greenwell, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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Graduate Periodontics Clinic, University of Louisville
Louisvile, Kentucky, United States
Countries
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Other Identifiers
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12.0455
Identifier Type: -
Identifier Source: org_study_id