Clinical trial NCT06292234: Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla
Official title: External Distraction Using Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla in Non-growing Cleft Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled trial with 1:1 allocation ratio and superiority framework
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Distraction effectiveness
timeFrame: immediate postoperative, 4 months postoperatively, 10 months postoperatively
Secondary outcomes:
measure: Velopharyngeal insufficiency
timeFrame: Preoperative , 4 months postoperatively, 10 months postoperatively
measure: Speech
timeFrame: preoperative, 4 months postoperatively, and 10 months postoperatively
measure: Operative time
timeFrame: Immediate postoperative
measure: Wound dehiscence
timeFrame: immediate postoperative till 4 months postoperatively
measure: Infection
timeFrame: immediate postoperative till 4 months postoperatively
measure: Nerve affection
timeFrame: immediate postoperative till 4 months postoperatively
measure: Screw loosening
timeFrame: immediate postoperative till 4 months postoperatively
measure: Overall complications
timeFrame: immediate postoperative, 4 months postoperatively and 10 months postoperatively
Other outcomes:
Locations:
Study officials:
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