Overview
Oral myofunctional disorders (OMD) are a key, internationally acknowledged environmental factor causing dental and skeletal malocclusion. For the past 15 years, research regarding the efficacy of orofacial myofunctional therapy (OMT) to reduce OMD and to contribute to the treatment of malocclusions has been significantly increased. Despite the growing interest, high-quality evidence is still lacking because studies show a lack of standardized assessment techniques, outcome measures, and inclusion criteria, important methodological limitations such as small sample sizes, a variety of content and service delivery models and a lack of long-term follow-up.
The goal of this clinical trial is to evaluate the effects of structured OMT on anterior open bite (AOB) in children in early or intermediate mixed dentition. The main questions it aims to answer are:
- Does a structured OMT program affect orofacial myofunctional patterns, dental occlusion, and oral health-related quality of life (OHRQoL) in children with AOB?
- Are there differences in treatment outcomes between children receiving a traditional OMT program, a reduced OMT program, and a sham treatment?
Participants will undergo baseline and follow-up assessments of dental occlusion, orofacial myofunctional patterns, and OHRQoL. They will follow a structured OMT protocol tailored to their assigned group and participate in weekly therapy sessions over a defined intervention period.
Eligibility
Inclusion Criteria:
- Presence of anterior open bite (AOB)
- Early or intermediate mixed dentition phase
Exclusion Criteria:
- History of or active engagement in orofacial myofunctional therapy (OMT)
- History of or active engagement in orthodontic therapy
- Congenital abnormalities, syndromes, or surgical needs affecting the oral and maxillofacial region
- Disorders affecting motor or cognitive development
- Current or recent (< 3 months) non-nutritive sucking habits