Evaluating the Impact of Prefabricated Acrylic Splints on Premaxillary Stability in Alveolar Cleft Bone Graft Repairs: a Randomized Controlled Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 20, 2025

Primary Completion Date

May 30, 2025

Study Completion Date

December 30, 2026

Conditions
Bilateral Complete Cleft Lip And/or Alveolus and Acrylic Splint, andMaxillary DeficiencyStability
Interventions
DEVICE

Clinical Trial Intervention Description General Study Setup Objective: To compare the efficacy of using a custom-made prefabricated acrylic splint versus no splint in maintaining premaxillary stabilit

"Clinical Trial Intervention Description General Study Setup Objective: To compare the efficacy of using a custom-made prefabricated acrylic splint versus no splint in maintaining premaxillary stability post-alveolar cleft repair.~Primary Outcome: Premaxillary stability. Secondary Outcomes: Wound healing and complications. Intervention Details~1\. Common Procedures for Both Arms:~Surgical Procedure: All surgical procedures will be conducted under general anesthesia with nasotracheal intubation.~Antibiotic Prophylaxis: A first-generation cephalosporin will be administered prior to incision as per .~Bone Graft Harvesting: Autogenous bone grafts will be harvested from the anterior iliac crest using a pediatric minimally invasive technique with a 2 cm skin incision 1 cm lateral to the iliac crest.~Alveolar Cleft Repair:~Incision and Flap Design: A sulcular incision will be made to develop full thickness mucoperiosteal advancement flaps extending into the cleft with caref"

All Listed Sponsors
lead

Cairo University

OTHER

NCT06807645 - Evaluating the Impact of Prefabricated Acrylic Splints on Premaxillary Stability in Alveolar Cleft Bone Graft Repairs: a Randomized Controlled Trial | Biotech Hunter | Biotech Hunter