Cleft Lip and Palate
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPSI
Fabrication of PSI implants using virtual surgical planning
DEVICEConventional miniplates
Ready made miniplates
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
single blinded clinical trial
Intervention model description
Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
1. Non growing cleft patients, age range (18-30 years) 2. Unilateral or bilateral cleft patients 3. Anteroposterior deficiency (1.5-2.5 cm) 4. No sex predilection
Exclusion criteria
1. Syndromic patients. 2. bone metabolism & systemic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distraction effectiveness | immediate postoperative, 4 months postoperatively, 10 months postoperatively | Amount of distraction using Lateral Cephalometry & FBCT measured in millimeters (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech | preoperative, 4 months postoperatively, and 10 months postoperatively | Nasometry Speech assessment; 1=absent, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe. |
| Operative time | Immediate postoperative | Measuring the time of the procedures in minutes |
| Wound dehiscence | immediate postoperative till 4 months postoperatively | Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No) |
| Velopharyngeal insufficiency | Preoperative , 4 months postoperatively, 10 months postoperatively | Scoring from 0 to 4; 0: Normal, 1: minimal, 2: mild, 3: moderate, 4: sever using endoscopy |
| Nerve affection | immediate postoperative till 4 months postoperatively | Clinical assessment of presence or absence of nerve affection (Binary: Yes or No) |
| Screw loosening | immediate postoperative till 4 months postoperatively | Clinical assessment of presence or absence of screw loosening (Binary: Yes or No) |
| Overall complications | immediate postoperative, 4 months postoperatively and 10 months postoperatively | Clinical assessment of presence or absence of complications (Binary: Yes or No) |
| Infection | immediate postoperative till 4 months postoperatively | Clinical assessment of presence or absence of infection (Binary: Yes or No) |
Outcome results
None listed