NCT06292234

Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla

External Distraction Using Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla in Non-growing Cleft Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
DEVICE	PSI	Fabrication of PSI implants using virtual surgical planning
DEVICE	Conventional miniplates	Ready made miniplates

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-02-01
• Completion: 2025-03-01
• First posted: 2024-03-05
• Last updated: 2024-04-19