Ridge Preservation Comparing Simultaneous vs. Delayed Grafting

Study Overview
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Brief Summary
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Comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.

Detailed Description
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The primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by Buser (test group).

Official Title
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Ridge Preservation Comparing the Traditional Approach vs. Early Implant Placement With Simultaneous Contour Augmentation

Conditions
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Tooth Loss

Intervention / Treatment
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* Procedure: Delayed graft
* Procedure: Simultaneous graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by 2 teeth. Healthy persons at least 18 years old. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria: Patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium. Exclude any molar tooth. Presence of or history of osteonecrosis of jaws. Patients with current or previous history of IV bisphosphonates, irrespective of duration. Patients taking oral bisphosphonates for ≥ 3 years. Pregnant women. Allergy to any material or medication used in the study. Patients who need prophylactic antibiotics prior to dental procedures. Previous head and neck radiation therapy. Chemotherapy in the previous 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed Grafting<br>8 weeks after extraction implant placement and simultaneous osseous grafting. | Procedure: Delayed graft<br>* 8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.<br>|
| Active Comparator: Simultaneous Grafting<br>At the time of extraction the socket will be grafted and implant placed 4 months later. | Procedure: Simultaneous graft<br>* At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final ridge width for simultaneous and delayed grafting treatment. | Measure final ridge width to determine if adequate bone is available. | 16 to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue thickness | Facial and occlusal | 16 to 20 weeks | 
| Histology | Histologic composition for control group only | 16 weeks | 
| Implant dehiscence | Implant dehiscence | 20 weeks |