Ridge Preservation Comparing 2 Membranes

Alveolar Ridge Deficiency Clinical Trial

Official title:

Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905280
• Other study ID #: 13.0330
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: December 6, 2016
• Start date: September 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2016
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.

Description:

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: 24
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• 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 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

• Alveolar Ridge Deficiency

Intervention

Procedure:
• Non-resorbable membrane
The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.
• Acellular dermal matrix
The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.

Locations

Country	Name	City	State
United States	Graduate Periodontics Clinic University of Louisville	Louisville	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 width of the ridge at the crest will be measured with a digital caliper.	4 months	No
Secondary	Percent vital bone	Percent vital bone at the graft site will be determined from a trephine core sample.	4 months	No