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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
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To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants.
Forty-two patients with 42 severe horizontal bone atrophy sites in the maxilla or mandible will be randomly assigned to two groups: ABG or GBR.
In the ABG group, a combination of ABG with particulate xenograft, covered with collagen membrane, will be used, while only a combination of particulate xenograft and collagen membrane alone will be in the GBR group. After 6-9 months of healing, implants were inserted. All implants will be definitively restored 6 months after implant placement. Radiographic examination (cone beam computed tomograms, CBCT) will be performed to evaluate the amount of horizontal bone width (HBW) gain immediately after bone grafting procedure (T0), at 6 months (T6), and at 18 months (T18). Patient demographic information, amount of width augmentation, implant survival, complications, and contributing factors will be gathered and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alveolar ridge augmentation without ABG | Active Comparator | Horizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG) |
|
| Alveolar ridge augmentation with ABG | Experimental | Horizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Horizontal ridge augmentation | Procedure | Surgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading. | Horizontal alveolar ridge changes in being assessed in the regenerated area. This outcome will be evaluated from pre-operatively (baseline), to 12 months after implant loading by measuring the alveolar ridge width at various points on the cross-sectional images using data obtained from CBCT scans. | From pre-operatively (baseline) to 12 months after implant loading. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant failure | The presence of an implant that requires implant removal (e.g., implant mobility). | At 6 months (T6), and at 18 months (T18) after implant placement. |
| Complications | Assessments of complications related to study procedures will be recorded during the follow up period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerardo Mendoza-Azpur, DDS | CientÃfica del Sur University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Periodontal Postgraduate Clinic at the Faculty of Dentistry, CientÃfica del Sur University | Lima | Peru |
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| ID | Term |
|---|---|
| D000540 | Alveolar Ridge Augmentation |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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Single center, prospective, controlled, parallel-armed, randomized clinical trial.
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Outcome measurements will be recorded by an examiner, who will not participate in any study procedure, and will be blind to the allocated treatment. This blinded examiner will be trained and calibrated to perform measurements. A dentist who is blinded to the treatment protocol will performe all radiographic measurements.
|
| 6 months |
| Regrafting necessity | Number of implants that needed regrafting to allow for ideal prosthetically driven implant placement. | At 6 months (T6). |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D014180 | Transplantation |