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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Fabrication of PSI implants using virtual surgical planning
Ready made miniplates
Distraction effectiveness
Amount of distraction using Lateral Cephalometry \& FBCT measured in millimeters (mm)
Time frame: immediate postoperative, 4 months postoperatively, 10 months postoperatively
Velopharyngeal insufficiency
Scoring from 0 to 4; 0: Normal, 1: minimal, 2: mild, 3: moderate, 4: sever using endoscopy
Time frame: Preoperative , 4 months postoperatively, 10 months postoperatively
Speech
Nasometry Speech assessment; 1=absent, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.
Time frame: preoperative, 4 months postoperatively, and 10 months postoperatively
Operative time
Measuring the time of the procedures in minutes
Time frame: Immediate postoperative
Wound dehiscence
Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No)
Time frame: immediate postoperative till 4 months postoperatively
Infection
Clinical assessment of presence or absence of infection (Binary: Yes or No)
Time frame: immediate postoperative till 4 months postoperatively
Nerve affection
Clinical assessment of presence or absence of nerve affection (Binary: Yes or No)
Time frame: immediate postoperative till 4 months postoperatively
Screw loosening
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Clinical assessment of presence or absence of screw loosening (Binary: Yes or No)
Time frame: immediate postoperative till 4 months postoperatively
Overall complications
Clinical assessment of presence or absence of complications (Binary: Yes or No)
Time frame: immediate postoperative, 4 months postoperatively and 10 months postoperatively