Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

Clinical Efficacy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900964
• Other study ID #: 12.0455
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: December 6, 2016
• Start date: October 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Efficacy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Graduate Periodontics Clinic, University of Louisville	Louisvile	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crestal ridge width	The crestal ridge width will be measured with a digital caliper at the baseline exam and at the 4 month examination.	Time 4 months	No
Secondary	Percent vital bone	A trephine core will be taken at 4 months immediately prior to implant placement from the implant osteotomy site.	Time 4 months	No