An interventional study of PSI and Conventional miniplates in Cleft Lip and Palate, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Custom made designed implants
Device: PSI
Over the counter miniplates
Device: Conventional miniplates
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2024; primary completion for Feb 2025, 9 months later.
Of 64 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's planned 9 months is below that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 15 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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