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

15. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

80

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Estonsko
      • Tartu, Estonsko, 50406
        • Tartu University Hospital, Clinic of Dentistry
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Orofacial Myofunctional Therapy
Participants receive semi-standardized orofacial myofunctional therapy for 8 months, with a total of 8 therapy sessions.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in normalized sEMG Area of the mylohyoid region during swallowing
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in tongue strength measured using the Iowa Oral Performance Instrument (IOPI)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Tartu University Hospital

Spolupracovníci

University of Tartu

Vyšetřovatelé

  • Studijní židle: Triin Jagomägi, PhD, University of Tartu

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

14. září 2026

Primární dokončení (Odhadovaný)

31. března 2028

Dokončení studie (Odhadovaný)

31. března 2028

Termíny zápisu do studia

První předloženo

8. září 2026

První předloženo, které splnilo kritéria kontroly kvality

15. září 2026

První zveřejněno (Aktuální)

18. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TEET295

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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