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Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue & better long-term stability & less relapse rate.
Maxillary distraction using rigid external distraction device (RED) with skeletal anchorage in cleft lip and palate overcomes the disadvantages of tooth brone RED & showed reliable advancement & reasonable relapse rate in the short & long-term follow up & most importantly it solved somehow counterclockwise rotation of maxilla but still it can occur. Positioning of plates in relation to center of resistance of maxilla to adjust vector of distraction can be done now by using Virtual surgical planning (VSP) & fabrication of patient specific implants (PSI) to overcome problems encountered with use of conventional miniplates during distraction process. Limited data in literature with no randomized clinical trials were done to assess distraction effectiveness using PSI in RED with skeletal anchorage and its effect on velopharyngeal insufficiency (VPI) & speech. Based on that data, the research will compare distraction effectiveness, VPI & speech between using either PSI implants or miniplates for distraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient specific implants | Experimental | Custom made designed implants |
|
| miniplates | Active Comparator | Over the counter miniplates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSI | Device | Fabrication of PSI implants using virtual surgical planning |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Distraction effectiveness | Amount of distraction using Lateral Cephalometry & FBCT measured in millimeters (mm) | immediate postoperative, 4 months postoperatively, 10 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Velopharyngeal insufficiency | Scoring from 0 to 4; 0: Normal, 1: minimal, 2: mild, 3: moderate, 4: sever using endoscopy | Preoperative , 4 months postoperatively, 10 months postoperatively |
| Speech |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework
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single blinded clinical trial
| Conventional miniplates |
| Device |
Ready made miniplates |
|
Nasometry Speech assessment; 1=absent, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.
| preoperative, 4 months postoperatively, and 10 months postoperatively |
| Operative time | Measuring the time of the procedures in minutes | Immediate postoperative |
| Wound dehiscence | Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No) | immediate postoperative till 4 months postoperatively |
| Infection | Clinical assessment of presence or absence of infection (Binary: Yes or No) | immediate postoperative till 4 months postoperatively |
| Nerve affection | Clinical assessment of presence or absence of nerve affection (Binary: Yes or No) | immediate postoperative till 4 months postoperatively |
| Screw loosening | Clinical assessment of presence or absence of screw loosening (Binary: Yes or No) | immediate postoperative till 4 months postoperatively |
| Overall complications | Clinical assessment of presence or absence of complications (Binary: Yes or No) | immediate postoperative, 4 months postoperatively and 10 months postoperatively |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |