The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite

What this Trial Is About

Researchers are investigating oral myofunctional therapy (OMT) as a treatment for anterior open bite (AOB) in children aged 6 to 12 years who are in the early or intermediate mixed dentition phase. The study aims to assess how a structured OMT program affects orofacial myofunctional patterns, dental occlusion, and oral health-related quality of life in children with AOB. It also compares outcomes between traditional OMT, reduced OMT, and a sham treatment to address current gaps in evidence, such as small sample sizes and lack of standardized assessments. Participants will be randomly assigned to one of three groups: traditional OMT, reduced OMT, or a sham treatment. Traditional OMT includes exercises focusing on orofacial strength, differentiation, breathing, resting postures, and swallowing, delivered in weekly 45-minute sessions over 10 weeks plus daily home practice. Reduced OMT involves a similar schedule but excludes some exercises, focusing only on differentiation, breathing, and resting postures. The sham treatment consists of vocal warm-up exercises without tongue or lip involvement, body posture, relaxation, and voice onset exercises, provided by the same speech therapist with comparable motivation techniques. Throughout the study, participants will undergo baseline and follow-up assessments of dental occlusion, orofacial myofunctional status, oral health-related quality of life, and orofacial strength from enrollment until 12 months after treatment ends. These evaluations will help measure changes in dental and orofacial functions as well as quality of life impacts. The trial uses a randomized, double-blind design to ensure unbiased results and aims to provide long-term data on OMT effectiveness in children with AOB.

Oral Myofunctional Pattern in Children With Anterior Open Bite