Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

Study Overview
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Brief Summary
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The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.

Official Title
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Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

Conditions
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Dental Implantation

Intervention / Treatment
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* Procedure: Alveolar ridge augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 21 and older 2-4 ADJACENT maxillary front teeth missing require ridge augmentation and dental implant nonsmoker for at least 6 months willing to follow oral hygiene instruction and other study instruction able to read, understand and sign informed consent Exclusion Criteria: Residual upper jaw bone equal to or narrower than 3mm. Insufficient gum tissue to obtain wound closure after surgery. Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult A history of head & neck radiation treatment due to certain medical conditions. Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for >7 days or any investigational drug Pregnancy or become pregnant during the length of the study Wearing removable partial dentures that may put pressure over the area where the bone graft will be placed.

Ages Eligible for Study
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Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healos<br> | Procedure: Alveolar ridge augmentation<br>* Under local anesthesia, full-thickness mucoperiosteal flaps will be elevated, followed by degranulation, and collection of all clinical measurements. Crestal and vertical releasing cuts will be performed using diamond-coated discs on the edentulous ridge in need of augmentation. A sequence of bone chisels and osteotomes will be used to split the alveolar ridge in half until a desirable width for implant placement is achieved. Healos® will then be inserted between both osseous plates. Fixation screws will be used as needed to stabilize the expanded alveolar ridge. Collagen barrier membranes (Ossix Plus) will be used to cover the osseous wound. Flaps will be approximated to achieve primary wound closure.<br>* Other names: Healos;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| horizontal (width) bone gain or loss in millimeters. |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic bone changes measured using computer tomography |  | 18 weeks | 
| percentage of new bone formation in the alveolar bone core biopsies. |  | 18 weeks |