Ridge Augmentation Without Primary Closure

Not Applicable

Completed

• Conditions: Alveolar Ridge Augmentation
• Interventions: Procedure: With primary closure; Procedure: Without primary closure

• Registration Number: NCT01901783
• Lead Sponsor: University of Louisville

Brief Summary

This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

Detailed Description

A maximum of 30 patients will be selected that meet the following criteria:

Inclusion Criteria

1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.

2. Healthy person that is at least 18 years old.

3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.

2. Previous head and neck radiation or chemotherapy within the previous 12 months.

3. Patients with known allergy to any of the materials that will be used in the study.

4. Smokers.

5. Patients who need prophylactic antibiotics prior to dental procedures.

6. Patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any IV biosphosphonates.

7. Patients who are pregnant.

Study Timeline

• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-17
• Study Start: 2013-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
2. Healthy person that is at least 18 years old.
3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
2. Previous head and neck radiation or chemotherapy within the previous 12 months.
3. Patients with known allergy to any of the materials that will be used in the study.
4. Smokers.
5. Patients who need prophylactic antibiotics prior to dental procedures.
6. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
7. Patients who are pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With primary closure	With primary closure	The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.
Without primary closure	Without primary closure	The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.

Primary Outcome Measures

Name	Time	Method
Crestal ridge width	4 months	The ridge width at the crest will be compared between the two treatment groups.

Secondary Outcome Measures

Name	Time	Method
Percent vital bone	4 months	The percent vital bone will be compared between the two treatment groups.

Trial Locations

Locations (1)

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