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

Cairo University (CU)

Status: Completed

Conditions: Maxillary Expansion; Cleft Lip and Palate

Treatments: Device: Maxillary Expansion

Study type: Interventional

Funder types: Other

Identifiers

NCT04331977

121

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Quadhelix Group

Experimental group

Treatment:

Device: Maxillary Expansion

Hyrax Group

Active Comparator group

Treatment:

Device: Maxillary Expansion