Ridge Preservation Comparing a PTFE Nonresorbable Membrane to a Collagen Membrane

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.

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.

Study Overview

• Status: Completed
• Conditions: Clinical Efficacy
• Intervention / Treatment: Procedure: PTFE membrane; Procedure: Collagen membrane

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisvile, Kentucky, United States, 40202
      • Graduate Periodontics Clinic, University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Allograft; Grafting, Bone; Bone regeneration; Xenograft; Regeneration
• Other Study ID Numbers: 12.0455