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This study will compare three methods to rebuild lost bone in the back part of the lower jaw (posterior mandible) before dental implant placement. Seventy-eight adults will be randomly assigned to receive one of three "cortical shell" techniques using either the patient's own bone (autogenous) or prefabricated bone plates from animal (xenogeneic) or human donors (allogeneic). In all groups, the space inside the shell will be filled with a mixture of small bone chips and bone substitute material. The main outcome is the increase in jawbone width measured on 3D cone-beam CT scans at 6 months after surgery. Additional scans and clinical assessments up to 12 months will evaluate healing, bone stability, and postoperative recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autogenous Cortical Shell Graft | Active Comparator | Thin cortical bone plates harvested from the mandibular ramus will be fixed to the recipient ridge with titanium microscrews to form a cortical shell. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft. This conventional technique represents the control group for comparison with xenogeneic and allogeneic materials. |
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| Xenogeneic Cortical Shell Graft | Experimental | Prefabricated bovine cortical laminae will be rehydrated, trimmed to contour, and fixed with titanium microscrews to the mandibular ridge. The enclosed space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft to promote bone regeneration. |
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| Allogenic Onlay bone graft | Experimental | A allogenic onlay cortical sheets will be adapted to the defect site, and fixed with titanium microscrews. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft, following the same standardized protocol as the other groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cortical Shell Bone Grafting | Procedure | Surgical reconstruction of atrophic posterior mandibular ridges using thin cortical plates fixed with titanium microscrews to form a biologic shell. The inner space is filled with a 1:1 mixture of autogenous bone chips and biomaterial. Depending on the study group, the cortical plates are autogenous (from the mandibular ramus), xenogeneic (bovine origin), or allogeneic (human donor). |
| Measure | Description | Time Frame |
|---|---|---|
| Horizontal Bone Gain (mm) Measured by CBCT | Linear horizontal bone gain at the grafted posterior mandibular ridge, measured on cone-beam computed tomography (CBCT) scans using standardized reference points. Measurements will be performed at 3, 6, and 12 months post-surgery by two calibrated, blinded examiners. Mean values per site will be compared among the three groups (autogenous, xenogeneic, allogeneic). | 3, 6, and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Duration (minutes) | Total surgical time for each bone augmentation procedure, measured from the first anesthetic injection to the final suture. Timing will be recorded using a standardized chronometer to compare operative efficiency across autogenous, xenogeneic, and allogeneic cortical shell techniques. | Day 0 (intraoperative measurement) |
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Inclusion Criteria:
Posterior mandibular edentulism requiring horizontal ridge augmentation (Cawood & Howell Classes IV-VI).
One or two eligible posterior mandibular sites suitable for cortical shell augmentation.
Adequate residual bone height to allow safe fixation above the mandibular canal.
Good general health (ASA I or II). Plaque index < 20% and absence of active periodontal infection. Ability and willingness to attend scheduled follow-up visits (up to 12 months). Written informed consent provided prior to any study-related procedure.
Exclusion Criteria:
Uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders).
Current heavy smoking (>5 cigarettes/day). Pregnancy or lactation. Current use of medications known to affect bone metabolism or healing (e.g., bisphosphonates, long-term corticosteroids, anticoagulants).
Active periodontal disease or untreated oral infection. History of chemotherapy or radiotherapy to the head and neck region.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio G Lanata-Flores | Contact | +593983820084 | alanataf@uees.edu.ec |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Espíritu Santo | Samborondón | Guayas | 092301 | Ecuador |
Yes, De-identified participant data and analysis code will be available upon reasonable request to the corresponding author after publication, following UEES data-sharing policies.
De-identified individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the main results and will remain accessible for 5 years thereafter through the institutional repository of Universidad de Especialidades Espíritu Santo (UEES).
Qualified researchers may request access to the anonymized dataset, protocol, statistical analysis plan, informed consent form, and analytic code by contacting the corresponding author at alanataf@uees.edu.ec. Requests will be reviewed by the study team and the UEES Ethics Committee to ensure compliance with ethical and privacy regulations. Approved users will receive controlled access to the data for non-commercial research purposes only.
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
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A randomized, statistician-blinded, parallel-group clinical trial will be conducted in 78 participants presenting with posterior mandibular bone atrophy. Participants will be allocated in a 1:1:1 ratio to receive autogenous, xenogeneic, or allogeneic cortical shell augmentation. Each participant will receive only one allocated intervention, and the unit of analysis for the primary endpoint will be the participant.
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This is an open-label surgical trial. Due to the nature of the interventions, participants, surgeons, and investigators cannot be blinded. The statistician responsible for the primary analysis will remain blinded to group allocation until completion of the primary analysis.
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| Bone Density (Hounsfield Units) on CBCT | Bone density within the grafted area will be measured using cone-beam computed tomography (CBCT) gray-scale analysis (Hounsfield unit equivalents). Segmentation and density quantification will be performed at standardized points within the augmented region by two blinded examiners. | 3, 6, and 12 months after surgery |
| Postoperative Inflammation (mm Facial Measurement) | Postoperative swelling will be assessed by measuring the linear distance from the lip commissure to the tragus with a flexible tape. Measurements will be taken bilaterally under standardized conditions by the same examiner to evaluate differences among groups. | Preoperative, immediate postoperative, days 3, 7, and 14 |
| Volumetric Bone Gain (mm³) | Three-dimensional volumetric changes of the augmented area will be calculated by superimposing pre- and postoperative CBCT-derived meshes using surface registration software. The difference in total reconstructed volume (ΔVolume) will quantify the amount of new bone formation across techniques. | 3, 6, and 12 months after surgery |
| Morphometric Surface Deviation (mm) | Surface deviation between pre- and postoperative 3D models will be analyzed using color-coded distance maps and point-to-surface metrics (mean absolute distance, RMS error, and 95th-percentile distance). This quantifies contour stability and remodeling patterns for each graft material. | 3, 6, and 12 months after surgery |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |