The Effect of Orofacial Myofunctional Therapy on Neuromuscular Outcomes and Orofacial Function in Children and Adolescents in Estonia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-14
SponsorTartu University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Structural craniofacial anomalies or syndromes (e.g., cleft lip and/or palate).

A medical condition that prevents safe participation in therapy or study assessments.

Trial design

Design model

Single group

Treatments tested in this trial

  • Semi-standardized Orofacial Myofunctional Therapy

    Behavioral

    Participants receive semi-standardized orofacial myofunctional therapy over an 8-month period, consisting of 8 therapy sessions at approximately 4-6-week intervals. Individually tailored exercises target tongue strength and mobility, lip strength and closure, swallowing pattern, tongue resting posture, nasal breathing and reduction of mouth breathing, and other orofacial functional patterns. Exercises are practiced under therapist supervision and performed at home once daily according to an individualized exercise program. Simple non-invasive aids, including a spatula and a button attached to a string, may be used during exercises. The intervention corresponds to routine clinical care and does not involve invasive or painful procedures.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Orofacial Myofunctional TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in normalized sEMG Area of the mylohyoid region during swallowing

Surface electromyographic (sEMG) activity of the bilateral mylohyoid region is recorded during swallowing. The sEMG Area during swallowing is normalized to the sEMG Area recorded during maximal tongue-palate pressure using the Iowa Oral Performance Instrument (IOPI) bulb. Normalized Area (%) is calculated as: sEMG Area during swallowing / sEMG Area during maximal tongue-palate pressure × 100. Change in normalized Area is assessed across the study period.

Time frame
Baseline (T0), 4 months (T4), and 8 months (T8)

Secondary outcomes

1

Change in tongue strength measured using the Iowa Oral Performance Instrument (IOPI)

Maximum tongue strength is measured using the Iowa Oral Performance Instrument (IOPI) and expressed in kilopascals (kPa). Change in maximum tongue strength is assessed across the study period.

Time frame
Baseline (T0), 4 months (T4), and 8 months (T8)
2

Change in lingual swallowing pressure measured using the Iowa Oral Performance Instrument (IOPI)

Lingual swallowing pressure (LSP) is measured using the Iowa Oral Performance Instrument (IOPI) and expressed in kilopascals (kPa). Change in lingual swallowing pressure is assessed across the study period.

Time frame
Baseline (T0), 4 months (T4), and 8 months (T8)
3

Change in lip strength measured using the Iowa Oral Performance Instrument (IOPI)

Lip strength is measured using the Iowa Oral Performance Instrument (IOPI) and expressed in kilopascals (kPa). Change in lip strength is assessed across the study period.

Time frame
Baseline (T0), 4 months (T4), and 8 months (T8)
4

Change in tongue-to-incisive papilla opening (TIP)

Tongue-to-incisive papilla opening (TIP) is measured in millimeters (mm) with the tongue tip in contact with the incisive papilla. Change in TIP is assessed across the study period.

Time frame
Baseline (T0), 4 months (T4), and 8 months (T8)

Other outcomes

Sponsors and contacts

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Tartu University Hospital

Lead sponsor

University of Tartu

Collaborator

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