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

15 de septiembre de 2026 actualizado por: Tartu University Hospital

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estonia
      • Tartu, Estonia, 50406
        • Tartu University Hospital, Clinic of Dentistry
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Orofacial Myofunctional Therapy
Participants receive semi-standardized orofacial myofunctional therapy for 8 months, with a total of 8 therapy sessions.
Conductual: Semi-standardized Orofacial Myofunctional Therapy
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in normalized sEMG Area of the mylohyoid region during swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in tongue strength measured using the Iowa Oral Performance Instrument (IOPI)
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in lingual swallowing pressure measured using the Iowa Oral Performance Instrument (IOPI)
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in lip strength measured using the Iowa Oral Performance Instrument (IOPI)
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in tongue-to-incisive papilla opening (TIP)
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in lingual-palatal suction opening (LPS)
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in overall orofacial function assessed using a modified Orofacial Myofunctional Evaluation with Scores (OMES)
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the mylohyoid region during standardized solid-food swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the mylohyoid region during swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the mylohyoid region during swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the mylohyoid region during swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the masseter region during swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the masseter region during swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the masseter region during swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the mylohyoid region during standardized solid-food swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the mylohyoid region during standardized solid-food swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the masseter region during standardized solid-food swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the masseter region during standardized solid-food swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the masseter region during standardized solid-food swallowing
Periodo de tiempo: 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.
Baseline (T0), 4 months (T4), and 8 months (T8)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Tartu University Hospital

Colaboradores

University of Tartu

Investigadores

  • Silla de estudio: Triin Jagomägi, PhD, University of Tartu

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

14 de septiembre de 2026

Finalización primaria (Estimado)

31 de marzo de 2028

Finalización del estudio (Estimado)

31 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TEET295

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared with other researchers. Study data are processed in pseudonymized form in accordance with the approved study protocol and applicable data protection requirements. Study results will be reported only in aggregated and anonymized form.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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