Orofacial Myofunctional DisordersNCT07828769
The Effect of Orofacial Myofunctional Therapy on Neuromuscular Outcomes and Orofacial Function in Children and Adolescents in Estonia
A study testing Semi-standardized Orofacial Myofunctional Therapy in people with Orofacial Myofunctional Disorders, run by Tartu University Hospital at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Orofacial Myofunctional Disorders
- What is being tested?
- Semi-standardized Orofacial Myofunctional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEstonia
- Study dates
- 14 Sep 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia1 site
Tartu University Hospital, Clinic of Dentistry
Tartu, 50406
Pille Eikner, MSc, +3725056787, pille.eikner@kliinikum.ee
About this study
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.
Read the detailed description
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.
- Conditions
- Orofacial Myofunctional Disorders
- Being tested
- Semi-standardized Orofacial Myofunctional Therapy
- Keywords
- Orofacial myofunctional therapy, Children and adolescents, Surface electromyography, Treatment adherence, Orofacial function, Craniofacial phenotype, Iowa Oral Performance Instrument, Tongue Range of Motion Ratio, Orofacial Myofunctional Evaluation with Scores
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-standardized Orofacial Myofunctional TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Orofacial Myofunctional Therapy | Experimental | Participants receive semi-standardized orofacial myofunctional therapy for 8 months, with a total of 8 therapy sessions. Receives: Behavioral: Semi-standardized Orofacial Myofunctional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Secondary outcomes (18)
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in lingual-palatal suction opening (LPS)
Lingual-palatal suction opening (LPS) is measured in millimeters (mm) during lingual-palatal suction. Change in LPS is assessed across the study period.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in overall orofacial function assessed using a modified Orofacial Myofunctional Evaluation with Scores (OMES)
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the mylohyoid region during standardized solid-food swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the mylohyoid region during swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the mylohyoid region during swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the mylohyoid region during swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the masseter region during swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the masseter region during swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the masseter region during swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the mylohyoid region during standardized solid-food swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the mylohyoid region during standardized solid-food swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the masseter region during standardized solid-food swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the masseter region during standardized solid-food swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the masseter region during standardized solid-food swallowing
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.
Measured: Baseline (T0), 4 months (T4), and 8 months (T8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial Myofunctional DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group prospective longitudinal interventional study evaluating changes over time within the same participants receiving orofacial myofunctional therapy.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu
- Responsible party
- Sponsor
- Investigators
- Triin Jagomägi, PhD, Study chair, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828769
- Sponsor's protocol ID
- TEET295
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orofacial Myofunctional Therapy on Neuromuscular Outcomes and Orofacial Function in Children and Adolescents in Estonia
- ClinicalTrials.gov ID
- NCT07828769
- Acronym / sponsor ID
- TEET295
- Conditions
- Orofacial Myofunctional Disorders
- Keywords
- Orofacial myofunctional therapy, Children and adolescents, Surface electromyography, Treatment adherence, Orofacial function, Craniofacial phenotype, Iowa Oral Performance Instrument, Tongue Range of Motion Ratio
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- University of Tartu
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group prospective longitudinal interventional study evaluating changes over time within the same participants receiving orofacial myofunctional therapy.
| Arm | Type | Receives |
|---|---|---|
| Orofacial Myofunctional Therapy | Experimental | Behavioral: Semi-standardized Orofacial Myofunctional TherapyParticipants receive semi-standardized orofacial myofunctional therapy for 8 months, with a total of 8 therapy sessions. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- Structural craniofacial anomalies or syndromes (e.g., cleft lip and/or palate).
- A medical condition that prevents safe participation in therapy or study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-standardized Orofacial Myofunctional TherapyParticipants 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. | Behavioural | Orofacial Myofunctional Therapy |
Primary outcome
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.
18 secondary outcomes
Change in tongue strength measured using the Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in lingual swallowing pressure measured using the Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in lip strength measured using the Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in tongue-to-incisive papilla opening (TIP)
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in lingual-palatal suction opening (LPS)
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
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)
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)
Change in sEMG mean frequency of the mylohyoid region during swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the mylohyoid region during swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the mylohyoid region during swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean frequency of the masseter region during swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG mean power frequency of the masseter region during swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Change in sEMG Area of the masseter region during swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
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)
Change in sEMG Area of the mylohyoid region during standardized solid-food swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
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)
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)
Change in sEMG Area of the masseter region during standardized solid-food swallowing
Time frame: Baseline (T0), 4 months (T4), and 8 months (T8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Triin Jagomägi, PhD study chair
University of Tartu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-standardized Orofacial Myofunctional Therapy in people with Orofacial Myofunctional Disorders, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pille Eikner, MSc (+3725056787, pille.eikner@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in normalized sEMG Area of the mylohyoid region during swallowing (time frame: Baseline (T0), 4 months (T4), and 8 months (T8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.