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| Name | Class |
|---|---|
| Cairo University | OTHER |
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Comparative study to assess the ability of the patient specific PEEK sheets in ridge augmentation with using mixed Autogenous/Xenogenic bone graft vs the Bone Shell Technique regarding the time, accuracy and donor site morbidity .
A- Intervention Group (Patient specific PEEK sheets)
B- Control Group (Autogenous bone shell technique)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient specific PEEK sheets | Experimental | Patient specific PEEK sheets will be fixed with titanium screws and act as containment system for the mixed autogenous/xenogenic bone graft that will fill the gap between the sheets and the ridge . |
|
| Autogenous bone shell technique | Active Comparator | Bone shells will be fixed with titanium screws to the ridge and mixed autogenous/xenogenic bone graft will fill the gap between the shells and the ridge . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient specific PEEK sheets | Procedure | Computer aided sheet design |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Questionnaire will be used to evaluate the satisfaction , measuring unit Binary (YES/NO) | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone gain | Bone gain will be evaluated using the Computed tomography , measuring unit (mm) | 4-6 months post-operative |
| Bone quality | Histological analysis of bone core biopsy , measuring unit Osteon number |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Brakart, PhD | Cairo University | Study Director |
| Mohamed M Shaker, PhD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine - Cairo University | Giza | 12613 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33231752 | Derived | Mounir M, Morsy OAE, Amer H, Mounir S, Gibaly A. Assessment of bone quality using buccal and palatal autogenous cortical shells harvested from two different mandibular donor sites for maxillary alveolar ridge augmentation: a histomorphometric randomized clinical trial. Oral Maxillofac Surg. 2021 Jun;25(2):263-269. doi: 10.1007/s10006-020-00924-w. Epub 2020 Nov 24. |
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None because the two interventions requires different preoperative preparations , both the participants and the investigator can't be blinded .
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| Autogenous bone shell |
| Procedure |
autogenous retromolar/chin bone graft |
|
| 4-6 months post-operative |
| Soft tissue reaction | Clinical evaluation by caliber to measure thickness of keratinized mucosa ,measuring unit (mm) | 4-6 months postoperative |
| Intraoperative time | Using stop watch to measure the operative time | Intraoperative |