NCT07056296

Efficiency of Two Maxillary Expanders for Maxillary Arch Expansion in Bilateral Cleft Lip and Palate Patients

Efficiency of a New Versatile Three-Way Maxillary Expander Versus Modified Fan Expander for Maxillary Arch Expansion in Cleft Lip and Palate Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial is designed to compare between Fan expander with palatal springs appliance vs three-way expander regarding the their effectiveness in maxillary expansion in patients with bilateral cleft

Detailed description

The study provides three-dimensional expansion for cleft lip and palate patients. Patients with repaired cleft lip and/or palate have maxillary deficiency and hypoplasia in the three planes of space. Most cases have a normal buccolingual occlusal relation in the molar region between upper and lower jaws, while they manifest arch constriction at the anterior inter-canine width area as well as premaxillary collapse and anterior crossbite. Conventional expansion appliances address only the transverse discrepancy requiring a further step to re-align the premaxilla. So, the aim of the study is to compare the efficiency and the effects of the new design of the three-way palatal expander and the modified fan expander in maxillary arch development in cleft lip and palate patients.

Conditions

• Bilateral Cleft Lip and Palate
• Maxillary Expansion

Interventions

Type	Name	Description
DEVICE	3D Maxillary Expansion with 3 expansion screws	In patients requiring maxillary expansion, after randomization and allocation for each to receive which expander, appliance will be cemented. In the 3-way group (A), 3 screw activations will be delivered by the care giver to expand the maxillary arch in 3D manner correcting the collapsed arch anteriorly.
DEVICE	3D Maxillary Expansion using modified Fan expander with springs	For the fan expander with palatal springs (B) , spring activation will be done by the operator after cemenation intraorally, then the care giver too will just activate one fan screw. Also 3D expansion evaluation was done.

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-02-26
• Completion: 2025-03-27
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: Egypt