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The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customized CAD/CAM Titanium Mesh | Experimental | A customized CAD/CAM Titanium Mesh will be used to cover the bone graft |
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| Reinforced Perforated PTFE Mesh (RPM) | Active Comparator | A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided bone regeneration (GBR) | Procedure | A composite graft composed of a 50:50 proportion of autogenous bone and a demineralized bone mineral will be positioned around the bony defect or placed in the membrane, depending on the group randomization. The selected membrane will then be secured with screws to ensure a complete and stable coverage of the grafted area. |
| Measure | Description | Time Frame |
|---|---|---|
| Ridge width changes in mm | Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements | 6 months |
| Ridge height changes in mm | Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mucosal thickness in mm | Change in the mucosal thickness due to the provided space from baseline to the surgical mesh removal using an ultrasound | 6 months |
| Histological outcomes of the augmented bone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hom-Lay Wang, DDS MSD PhD | Department of Periodontics and Oral Medicine, University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
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In terms of the amount of newly formed vital bone, residual graft particles, and connective tissue (CT)/other non-mineralized tissue components as a percentage
| 6 months |
| The volumetric bone gain of the grafted area in mm3 | Radiographic changes of bone volume based on cone-beam computed tomography (CBCT) scan measurements | 6 months |
| Rate of complications | Percentage that had complications associated with each technique | 6 months |
| Cost analysis | Difference in cost-effectiveness in dollars | 6 months |