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Evaluation of Myobrace for Crossbite Correction in Mixed Dentition
Sponsor: Sana'a University
Summary
This randomized controlled clinical trial will evaluate the effectiveness of the Myobrace appliance in correcting anterior and posterior crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare the clinical effects of Myobrace with those of the Frankel III appliance. The study will assess changes in occlusion, skeletal and dentoalveolar relationships, and soft tissue characteristics before and after treatment. The study will also evaluate the effectiveness of the two treatment approaches in improving crossbite correction and related orthodontic outcomes.
Official title: Evaluation of the Myobrace Appliance in Correcting Crossbite During the Mixed Dentition Stage: A Randomized, Controlled Clinical Trial
Key Details
Gender
All
Age Range
6 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-04-23
Completion Date
2027-09
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Myobrace Interceptive Class III Appliance
Participants will receive the Myobrace® Interceptive Class III appliance during the mixed dentition stage. The appliance will be used according to the study treatment protocol, with instructions for approximately 1-2 hours of daytime wear and overnight wear, together with daily myofunctional exercises and instructions regarding nasal breathing, tongue posture, swallowing, and lip competence. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first.
Frankel III Functional Regulator
Participants will receive the Frankel III (FR-III) functional regulator during the mixed dentition stage. The appliance will be used according to the study treatment protocol. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. Clinical and cephalometric assessments will be performed before and after treatment to evaluate changes in skeletal, dentoalveolar, and occlusal relationships.
Locations (1)
Faculty of Dentistry, Sana'a University
Sanaa, Amanat Al Asimah, Yemen