Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate

Not Applicable

Completed

• Conditions: Cleft Lip and Palate; Maxillary Expansion

• Registration Number: NCT04331977
• Lead Sponsor: Cairo University

Brief Summary

This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax expander regrading the their effectiveness in maxillary expansion in patients with cleft.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-07-02
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-11
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Mixed dentition stage;
• Both males and females;
• Lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age;
• Presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft;
• Permanent first maxillary molars present;
• Good periodontal health;
• No previous orthodontic treatment; and

Exclusion Criteria

• Presence of a syndrome in companion with the present cleft defect.
• Previous secondary alveolar bone grafting.
• Taking medications affecting growth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maxillary Expansion	6 months	mount of Maxillary Expansion to be measured as angles (degrees) on CBCTs and dental models.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Giza, Egypt