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

Not Applicable

Completed

• Conditions: Bilateral Cleft Lip and Palate; Maxillary Expansion

• Registration Number: NCT07056296
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05-30
• Primary Completion: 2025-02-26
• Study Completion: 2025-03-27
• Study First Submitted: 2025-06-15
• Study First Submitted QC: 2025-06-29
• Last Update Submitted: 2025-06-29
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maxillary arch development in Anteroposterior dimension	[Time Frame: 6 - 12 months]	Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms

Secondary Outcome Measures

Name	Time	Method
Inter-canine width expansion in the transverse plane	[Time Frame: 6- 12 months]	Inter-canine width expansion in the transverse plane measured on Digital dental models.
Dental changes with expansion	[Time Frame: 6- 12 months]	Amount of dental tipping occurring with expansion and amount of expansion and distal movement of maxillary molars

Trial Locations

Locations (1)

Department of Orthodontics, Faculty of Dentistry, Ain Shams University; 🇪🇬 Cairo, Abbaseya, Egypt