Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

Sponsor

University of Louisville (Other)

Overall Status

Completed

CT.gov ID

NCT01900964

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Efficacy	Procedure: PTFE membrane Procedure: Collagen membrane	N/A

Detailed Description

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

Inclusion 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.

Exclusion Criteria

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Oct 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Graduate Periodontics Clinic, University of Louisville	Louisvile	Kentucky	United States	40202

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator: Henry Greenwell, DMD, University of Louisville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Henry Greenwell, Professor, University of Louisville

ClinicalTrials.gov Identifier:

NCT01900964

Other Study ID Numbers:

12.0455

First Posted:

Jul 17, 2013

Last Update Posted:

Dec 8, 2016

Last Verified:

May 1, 2014

Keywords provided by Henry Greenwell, Professor, University of Louisville

Study Results

No Results Posted as of Dec 8, 2016