Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

Not Applicable

Not yet recruiting

• Conditions: Cleft Lip and Palate
• Interventions: Device: Conventional miniplates; Device: PSI

• Registration Number: NCT06292234
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-03-02
• Study First Posted: 2024-03-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Study Start: 2024-05-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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Exclusion Criteria

1. Syndromic patients.
2. bone metabolism & systemic diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
miniplates	Conventional miniplates	Over the counter miniplates
patient specific implants	PSI	Custom made designed implants

Primary Outcome Measures

Name	Time	Method
Distraction effectiveness	immediate postoperative, 4 months postoperatively, 10 months postoperatively	Amount of distraction using Lateral Cephalometry \& FBCT measured in millimeters (mm)

Secondary Outcome Measures

Name	Time	Method
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)
Operative time	Immediate postoperative	Measuring the time of the procedures in minutes
Overall complications	immediate postoperative, 4 months postoperatively and 10 months postoperatively	Clinical assessment of presence or absence of complications (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
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.
Wound dehiscence	immediate postoperative till 4 months postoperatively	Clinical assessment of presence or absence of wound dehiscence (Binary: Yes or No)
Infection	immediate postoperative till 4 months postoperatively	Clinical assessment of presence or absence of infection (Binary: Yes or No)