Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

Not Applicable

Completed

• Conditions: Clinical Efficacy
• Interventions: Procedure: PTFE membrane; Procedure: Collagen membrane

• Registration Number: NCT01900964
• Lead Sponsor: University of Louisville

Brief Summary

A non-resorbable PTFE (teflon) membrane will be compared to a resorbable collagen membrane when used for a post-extraction ridge preservation procedure to prevent the bone loss that typically occurs. The hypothesis is that there will be no difference in the clinical and histologic results between the two membranes.

Detailed Description

Patient Selection 30 patients will be selected that meet the following criteria:

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-17
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-05
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 (nonsteroidal anti-inflammatory drug) or steroid therapy.
10. Pregnant patients. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTFE membrane	PTFE membrane	A non-resorbable PTFE (polytetrafluoroethylene) membrane will be used as a positive control treatment.
Collagen membrane	Collagen membrane	A resorbable collagen membrane will be used in the test group.

Primary Outcome Measures

Name	Time	Method
Crestal ridge width	Time 4 months	The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination.

Secondary Outcome Measures

Name	Time	Method
Percent vital bone	Time 4 months	A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site.

Trial Locations

Locations (1)

Graduate Periodontics Clinic, University of Louisville; 🇺🇸 Louisvile, Kentucky, United States