NCT07828769

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 8, 2026

Last Update Submit

September 15, 2026

Conditions

Orofacial Myofunctional Disorders

Keywords

Orofacial myofunctional therapyChildren and adolescentsSurface electromyographyTreatment adherenceOrofacial functionCraniofacial phenotypeIowa Oral Performance InstrumentTongue Range of Motion RatioOrofacial Myofunctional Evaluation with Scores

Outcome Measures

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.

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

Secondary Outcomes (18)

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

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

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

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

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

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

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

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

  • Change in lingual-palatal suction opening (LPS)

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

  • +13 more secondary outcomes

Study Arms (1)

Orofacial Myofunctional Therapy

EXPERIMENTAL

Participants receive semi-standardized orofacial myofunctional therapy for 8 months, with a total of 8 therapy sessions.

Behavioral: Semi-standardized Orofacial Myofunctional Therapy

Interventions

Semi-standardized Orofacial Myofunctional TherapyBEHAVIORAL

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.

Orofacial Myofunctional Therapy

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Structural craniofacial anomalies or syndromes (e.g., cleft lip and/or palate).
  • A medical condition that prevents safe participation in therapy or study assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital, Clinic of Dentistry

Tartu, 50406, Estonia

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Triin Jagomägi, PhD

    University of Tartu

    STUDY CHAIR

Central Study Contacts

Pille Eikner, MSc

CONTACT

+3725056787pille.eikner@kliinikum.ee

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-group prospective longitudinal interventional study evaluating changes over time within the same participants receiving orofacial myofunctional therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 18, 2026

Study Start

September 14, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

ES(1)