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NCT07828769
The Effect of Orofacial Myofunctional Therapy on Neuromuscular Outcomes and Orofacial Function in Children and Adolescents in Estonia
Conditions: Orofacial Myofunctional Disorders
Sex: All
Ages: 7 Years – 14 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Tartu University Hospital
Location: Tartu University Hospital, Clinic of Dentistry Tartu
Summary
The aim of the present study is to evaluate the effects of semi-standardized myofunctional therapy on the functional and neuromuscular characteristics of the orofacial system in children and adolescents aged 7-14 years using a longitudinal study design and a unified assessment protocol. Myofunctional therapy is a treatment method for functional disorders of the oral, lingual, and facial regions. The study approaches the orofacial system holistically by linking functional characteristics with anatomical structures, including palatal morphology and skeletal and dentoalveolar occlusal relationships, while also considering the impact of treatment adherence on outcomes.
Participants' orofacial functions and neuromuscular characteristics will be assessed before, during, and after therapy using standardized clinical measurements. The study will analyze the dynamics of changes, individual variability, and associations with craniofacial phenotype and treatment adherence.
Despite the widespread use of myofunctional therapy in Estonia, systematic evidence regarding therapy effectiveness, treatment dynamics, and factors influencing outcomes is limited, and unified assessment and intervention standards are lacking. The study aims to address this knowledge gap and support evidence-based implementation of myofunctional therapy, clinical decision-making, and healthcare resource planning.
Eligibility Criteria
Inclusion Criteria:
* Age 7-14 years at the time of enrollment.
* Referred for orofacial myofunctional therapy.
* Diagnosed with an orofacial myofunctional disorder.
* Willingness to participate in therapy and assessments according to the study protocol.
* Written informed consent from a parent or legal guardian for the child's participation in the study.
* Written informed assent from the child to participate in the study.
* Written consent from a parent or legal guardian to participate in the study by completing the questionnaire assessing their child's treatment adherence.
* Sufficient proficiency in Estonian to participate in the study and understand the study procedures.
Exclusion Criteria:
* Structural craniofacial anomalies or syndromes (e.g., cleft lip and/or palate).
* A medical condition that prevents safe participation in therapy or study assessments.
Source: ClinicalTrials.gov (NCT07828769). StuddyBuddy aggregates publicly available trial information.