Evaluation of Myobrace for Crossbite Correction in Mixed Dentition

NCT07840053 | Active Not Recruiting

• 1 other identifier: PE:01/09/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cross Bite

Keywords

Crossbite; Anterior Crossbite; Posterior Crossbite; Myobrace; Frankel III; Mixed Dentition; Interceptive Orthodontics

Outcome Measures

Primary Outcomes (1)

• Change in Crossbite Correction Status

  Change in occlusal crossbite status from baseline to treatment completion, assessed clinically by the presence or absence of anterior and/or posterior crossbite. Complete correction is defined as establishment of a normal anterior and/or posterior buccolingual occlusal relationship according to the type of crossbite present at baseline. The change will be assessed for each participant by comparing the post-treatment crossbite status with the participant's baseline status. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.

  Baseline, and up to 18 months

Secondary Outcomes (32)

• Change in Overjet

  Baseline, and up to 18 months.

• Change in Overbite

  Baseline, and up to 18 months.

• Anterior Crossbite Correction

  Baseline, and up to 18 months.

• Posterior Crossbite Correction

  Baseline, and up to 18 months.

• Change in ANB

  Baseline, and up to 18 months.

Study Arms (2)

Myobrace Group

EXPERIMENTAL

Participants assigned to this arm will receive the Myobrace® Interceptive Class III appliance during the mixed dentition stage. Participants will be instructed to wear the appliance for approximately 1-2 hours during the day and overnight, 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.

Device: Myobrace Interceptive Class III Appliance

Frankel III Group

ACTIVE COMPARATOR

Participants assigned to this arm will receive the Frankel III (FR-III) functional regulator during the mixed dentition stage. The appliance will be used according to the clinical 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.

Device: Frankel III Functional Regulator

Interventions

Myobrace Interceptive Class III Appliance DEVICE

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.

Myobrace Group

Frankel III Functional Regulator DEVICE

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.

Also known as: FR-III

Frankel III Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of anterior crossbite, posterior crossbite, or both.
• Yemeni children aged 6 to 10 years.
• Children in the mixed dentition stage.
• No history of prior orthodontic treatment.

You may not qualify if:

• Children with craniofacial anomalies, such as cleft lip and palate.
• Children with severe jaw misalignment requiring complex therapy.
• Children with complete permanent dentition.
• Children currently undergoing orthodontic treatment
• Children or parents/guardians unwilling to provide informed consent or participate in the study.
• Children with predicted or observed poor compliance, including behavioral issues that may interfere with treatment or study procedures.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Faculty of Dentistry, Sana'a University

Sanaa, Amanat Al Asimah, Yemen

Location

Related Publications (8)

• Pham TT, Tran BC, Pham TTH. Effectiveness of Myobrace Therapy in Correcting Anterior Crossbite in Early Mixed Dentition: A Retrospective Study. Int J Clin Pediatr Dent. 2025 Oct;18(10):1243-1248. doi: 10.5005/jp-journals-10005-3281. Epub 2025 Oct 18.

  PMID: 41211360 BACKGROUND

• Mareddy AR, Reddy VN, Done V, Rehaman T, Vemula ADNK, Narahari S, Jukanti S. Early Intervention for Malocclusion: Role of Myobrace in Children Aged 6-10 Years. Int J Clin Pediatr Dent. 2025 Aug;18(8):956-963. doi: 10.5005/jp-journals-10005-3193. Epub 2025 Sep 4.

  PMID: 40989970 BACKGROUND

• Aytan S, Yukay F, Cigler S, Enacar A, Aksoy A, Telli AE. [Frankel III appliance]. Turk Ortodonti Derg. 1989 Nov;2(2):338-45. Turkish.

  PMID: 2489168 BACKGROUND

• Perillo L, Vitale M, Masucci C, D'Apuzzo F, Cozza P, Franchi L. Comparisons of two protocols for the early treatment of Class III dentoskeletal disharmony. Eur J Orthod. 2016 Feb;38(1):51-56. doi: 10.1093/ejo/cjv010. Epub 2015 Mar 13.

  PMID: 25770942 BACKGROUND

• Borrie F, Bearn D. Early correction of anterior crossbites: a systematic review. J Orthod. 2011 Sep;38(3):175-84. doi: 10.1179/14653121141443.

  PMID: 21875991 BACKGROUND

• Kecik D, Kocadereli I, Saatci I. Evaluation of the treatment changes of functional posterior crossbite in the mixed dentition. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):202-15. doi: 10.1016/j.ajodo.2005.03.030.

  PMID: 17276861 BACKGROUND

• Wiedel AP, Bondemark L. Stability of anterior crossbite correction: a randomized controlled trial with a 2-year follow-up. Angle Orthod. 2015 Mar;85(2):189-95. doi: 10.2319/041114-266.1. Epub 2014 Jul 8.

  PMID: 25004240 BACKGROUND

• Bahrun AN, Erwansyah E, Ranggang BM, Pawinru A, Nasir M. Myofunctional orthodontic therapy in Class III dentoskeletal malocclusion using Myobrace appliance and inclined bite plane: Case report. Indonesian Journal of Orthodontics Case Report. 2024;1(1):16-24.

  BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dr.Tharwa Alawadi, BDS, MSc

  Sana'a University, Faculty of Dentistry

  STUDY DIRECTOR

• Khaled AL-Haddad, Professor

  Sana'a University, Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher in Clinical Dentistry (Pediatric Dentistry)

Model Details: Group 1 will receive the Myobrace® Interceptive Class III appliance, and Group 2 will receive the Frankel III appliance. Treatment will be provided during the mixed dentition stage, with pre-treatment and post-treatment assessments performed using clinical examination, photographs, study models, and lateral cephalometric radiographs.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 24, 2026
• Study Start: April 23, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)