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

NCT ID: NCT07056296

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2025-03-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Three-way iMini Hyrax group

For group (A) cases, a custom-made Three-way palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. Three mini-expansion screws with two break resistant retention legs, oriented as follows: a transverse screw and bilateral sagittal screws.

Group Type: EXPERIMENTAL

3D Maxillary Expansion with 3 expansion screws

Intervention Type: DEVICE

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.

Fan Expander group

For group (B) cases, a custom-made modified Fan palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. A fan expansion screw with break resistant retention legs with soldered finger springs just palatal to the premaxilla.

Group Type: ACTIVE_COMPARATOR

3D Maxillary Expansion using modified Fan expander with springs

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

3-way expander; Group (A); Fan expander; Group (B)

Eligibility Criteria

Inclusion Criteria

• Patients with age ranging from 8 to 15 years old.
• Patients with bilateral cleft lip and palate.
• Patients with repaired cleft lip and / or palate.
• Patients with fully erupted upper permanent 1st molars.
• Patients in the late mixed or early permanent dentition with tapered maxillary arch, requiring palatal expansion as part of their treatment.
• Patient's stage of cervical vertebral maturation before or at the growth spurt (CS1-CS4).

Exclusion Criteria

• Patients with syndromic cleft lip and palate.
• Patients with very bad oral hygiene and active periodontal disease.
• Vulnerable groups

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Orthodontics, Faculty of Dentistry, Ain Shams University

Cairo, Abbaseya, Egypt

Countries

Egypt

Other Identifiers

FDASU-Rec ID 052316

Identifier Type: -

Identifier Source: org_study_id