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The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients
Stereographic models were used for construction of bone-born custom-made intraoral distractor according to the inclusion and exclusion criteria, followed up to measure and determine the efficiency of the distractor
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone-Borne Intra-oral distractor | Experimental | Surgeries to fix the device were conducted under GA. Then latency period of seven days was applied. Activation was 0.5 mm twice a day. The transport segment touched the docking site then the Consolidation period is achieved. Follow up for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone-borne Intra oral distractor | Device | Evaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome) | The alveolar cleft defect area will be quantitatively measured using cone-beam computed tomography (CBCT). Preoperative and postoperative CBCT scans will be superimposed to calculate the change in defect area following distraction osteogenesis. | 6 months postoperative follow up |
| Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility) | Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment. | 6 months postoperative follow up |
| Vitality of the transported bone segment assessed by clinical vitality indicators after transport distraction osteogenesis (binary outcome: viable / non-viable; viable outcome indicates better result) | Vitality of the transported disk after transport distraction osteogenesis is measured through clinical indicators as No infection, No pain or inflammation, Stable transported segment, Successful consolidation phase. | 6 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanaa Elmorsy, Assis.Lec | Assistant lecturer of OMFs department Azhar University | Study Chair |
| Susan H Abdel Hakim, professor | Professor of OMFs department azhar university | Study Director |
| Wael Shawkat, Consultant | Head of the department at the Health Insurance Hospital | Study Director |
| Fatema khalifa, Assist.Prof | Assistant Professor of OMFs Azhar university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of oral and dental medicine for Girls AlAzhar University | Cairo | Cairo Governorate | 12345 | Egypt |
Detailed Protocol
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| ID | Term |
|---|---|
| D000070631 | Diastasis, Bone |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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stereographic models were used for construction of bone-borne custom-made intraoral distractor
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This wasn't applicable during surgery and follow-up
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