Ridge Augmentation Without Primary Closure

Study Overview
=================
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 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. Healthy person that is at least 18 years old. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment. Previous head and neck radiation or chemotherapy within the previous 12 months. Patients with known allergy to any of the materials that will be used in the study. Smokers. Patients who need prophylactic antibiotics prior to dental procedures. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates. Patients who are pregnant.

Official Title
-----------------
Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure

Conditions
-----------------
Alveolar Ridge Augmentation

Intervention / Treatment
-----------------
* Procedure: With primary closure
* Procedure: Without primary closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Healthy person that is at least 18 years old. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria: Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment. Previous head and neck radiation or chemotherapy within the previous 12 months. Patients with known allergy to any of the materials that will be used in the study. Smokers. Patients who need prophylactic antibiotics prior to dental procedures. Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates. Patients who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With primary closure<br>The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed. | Procedure: With primary closure<br>* A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.<br>* Other names: Primary soft tissue closure over the membrane.;|
| Experimental: Without primary closure<br>The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed. | Procedure: Without primary closure<br>* A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will not be primarily closed over the membrane.<br>* Other names: No primary soft tissue closure over the membrane.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crestal ridge width | The ridge width at the crest will be compared between the two treatment groups. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent vital bone | The percent vital bone will be compared between the two treatment groups. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allograft, regeneration, alveolar ridge