Ridge Preservation Comparing 2 Membranes

Not Applicable

Completed

• Conditions: Alveolar Ridge Deficiency
• Interventions: Procedure: Acellular dermal matrix; Procedure: Non-resorbable membrane

• Registration Number: NCT01905280
• Lead Sponsor: University of Louisville

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Study Start: 2013-09
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acellular dermal matrix	Acellular dermal matrix	A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane.
Non-resorbable membrane	Non-resorbable membrane	A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane.

Primary Outcome Measures

Name	Time	Method
Crestal ridge width	4 months	The width of the ridge at the crest will be measured with a digital caliper.

Secondary Outcome Measures

Name	Time	Method
Percent vital bone	4 months	Percent vital bone at the graft site will be determined from a trephine core sample.

Trial Locations

Locations (1)

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