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NCT Number: NCT07828769

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

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.

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Key information

Conditions

Orofacial Myofunctional Disorders Behavior Health Behavior Treatment Adherence and Compliance

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a prospective longitudinal clinical interventional study conducted at the Department of Paediatric Dentistry, Stomatology Clinic, Tartu University Hospital, Estonia. The study will include up to 80 children and adolescents aged 7-14 years who have been referred for orofacial myofunctional therapy and meet the study eligibility criteria.

Participants will receive semi-standardized orofacial myofunctional therapy as part of their clinical treatment. The study period for each participant is approximately nine months, including an eight-month therapy intervention with eight therapy sessions conducted at intervals of approximately 4-6 weeks.

Standardized clinical assessments are performed at baseline (T0, visit 1), during therapy (T4, visit 5), and after completion of the intervention (T8, visit 9). The assessments include neuromuscular and orofacial functional measurements. Treatment adherence is assessed throughout the intervention period using standardized questionnaires completed from the perspectives of the child, parent or legal representative, and therapist.

The study also evaluates craniofacial and dentoalveolar characteristics as exploratory factors in relation to treatment response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in normalized sEMG Area of the mylohyoid region during swallowing

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  5. Change in lingual-palatal suction opening (LPS)

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

    Lingual-palatal suction opening (LPS) is measured in millimeters (mm) during lingual-palatal suction. Change in LPS is assessed across the study period.

  6. Change in overall orofacial function assessed using a modified Orofacial Myofunctional Evaluation with Scores (OMES)

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

    Orofacial function is assessed using a modified Orofacial Myofunctional Evaluation with Scores (OMES). The modified total score ranges from 34 to 98 points, with higher scores indicating better orofacial function. Change in the modified total OMES score is assessed across the study period.

  7. Change in sEMG mean frequency of the mylohyoid region during standardized solid-food swallowing

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

    Surface electromyographic (sEMG) mean frequency (MF) of the bilateral mylohyoid region is recorded during standardized swallowing of an approximately 5 g apple slice and expressed in hertz (Hz). One practice trial is performed before measurement, and the mean of two measurement trials is used for analysis. Change in MF is assessed across the study period.

  8. Change in sEMG mean frequency of the mylohyoid region during swallowing

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

    Surface electromyographic (sEMG) mean frequency (MF) of the bilateral mylohyoid region is recorded during swallowing and expressed in hertz (Hz). Change in MF is assessed across the study period.

  9. Change in sEMG mean power frequency of the mylohyoid region during swallowing

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

    Surface electromyographic (sEMG) mean power frequency (MPF) of the bilateral mylohyoid region is recorded during swallowing and expressed in hertz (Hz). Change in MPF is assessed across the study period.

  10. Change in sEMG Area of the mylohyoid region during swallowing

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

    Surface electromyographic (sEMG) Area of the bilateral mylohyoid region is recorded during swallowing and expressed in microvolt-seconds (µV·s). Change in sEMG Area is assessed across the study period.

  11. Change in sEMG mean frequency of the masseter region during swallowing

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

    Surface electromyographic (sEMG) mean frequency (MF) of the bilateral masseter region is recorded during swallowing and expressed in hertz (Hz). Change in MF is assessed across the study period.

  12. Change in sEMG mean power frequency of the masseter region during swallowing

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

    Surface electromyographic (sEMG) mean power frequency (MPF) of the bilateral masseter region is recorded during swallowing and expressed in hertz (Hz). Change in MPF is assessed across the study period.

  13. Change in sEMG Area of the masseter region during swallowing

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

    Surface electromyographic (sEMG) Area of the bilateral masseter region is recorded during swallowing and expressed in microvolt-seconds (µV·s). Change in sEMG Area is assessed across the study period.

  14. Change in sEMG mean power frequency of the mylohyoid region during standardized solid-food swallowing

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

    Surface electromyographic (sEMG) mean power frequency (MPF) of the bilateral mylohyoid region is recorded during standardized swallowing of an approximately 5 g apple slice and expressed in hertz (Hz). One practice trial is performed before measurement, and the mean of two measurement trials is used for analysis. Change in MPF is assessed across the study period.

  15. Change in sEMG Area of the mylohyoid region during standardized solid-food swallowing

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

    Surface electromyographic (sEMG) Area of the bilateral mylohyoid region is recorded during standardized swallowing of an approximately 5 g apple slice and expressed in microvolt-seconds (µV·s). One practice trial is performed before measurement, and the mean of two measurement trials is used for analysis. Change in sEMG Area is assessed across the study period.

  16. Change in sEMG mean frequency of the masseter region during standardized solid-food swallowing

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

    Surface electromyographic (sEMG) mean frequency (MF) of the bilateral masseter region is recorded during standardized swallowing of an approximately 5 g apple slice and expressed in hertz (Hz). One practice trial is performed before measurement, and the mean of two measurement trials is used for analysis. Change in MF is assessed across the study period.

  17. Change in sEMG mean power frequency of the masseter region during standardized solid-food swallowing

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

    Surface electromyographic (sEMG) mean power frequency (MPF) of the bilateral masseter region is recorded during standardized swallowing of an approximately 5 g apple slice and expressed in hertz (Hz). One practice trial is performed before measurement, and the mean of two measurement trials is used for analysis. Change in MPF is assessed across the study period.

  18. Change in sEMG Area of the masseter region during standardized solid-food swallowing

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

    Surface electromyographic (sEMG) Area of the bilateral masseter region is recorded during standardized swallowing of an approximately 5 g apple slice and expressed in microvolt-seconds (µV·s). One practice trial is performed before measurement, and the mean of two measurement trials is used for analysis. Change in sEMG Area is assessed across the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Pille Eikner, MSc

CONTACT

[email protected]

+3725056787

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Collaborators

  • University of Tartu

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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