Open BiteMyofunctionalNCT06574490
Myofunctional Therapy in Open Bite - RCT
A study testing Myofunctional therapy (+) and Myofunctional therapy (-) in people with Open Bite, run by Piotr Fudalej.
Trial summary
The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective. Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Bite
- What is being tested?
- Myofunctional therapy (+) and Myofunctional therapy (-)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy children aged 6-10 years,
- infant swallowing type,
- open anterior occlusion (i.e. no contact between the maxillary and mandibular medial incisors),
- mixed dentition
Who cannot join
- finger sucking habit (or similar) occurring within the last 6 months,
- previous myofunctional therapy,
- upper airway obstruction,
- congenital craniofacial developmental disorder,
- connective tissue or muscle disease,
- macroglossia,
- ankyloglossia,
- mental retardation
About this study
Official title: Effectiveness of Myofunctional Therapy in Children With Open Bite - a Randomized Clinical Trial
The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective.
Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year.
Participants will exercise according to a pre-established regimen and schedule
- Conditions
- Open Bite
- Being tested
- Myofunctional therapy (+), Myofunctional therapy (-)
- Keywords
- open bite, child, myofunctional, myotherapy, exercises
- Medical subject headings
- Open Bite, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional therapy (+)Procedure or surgery
A series of myofunctional exercises performed in 10-20 sessions over 6 months
Myofunctional therapy (-)Procedure or surgery
NO exercises; A series of myofunctional exercises performed in 10-20 sessions over 6 months is delayed by 1 year
| Study group | Role | What they receive |
|---|---|---|
| Myofunctional + | Experimental | A series of myofunctional exercises Receives: Procedure: Myofunctional therapy (+) |
| Myofunctional - | Active comparator | No exercises Receives: Procedure: Myofunctional therapy (-) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overbite
presence positive vertical (i.e. the upper teeth overlap the lower teeth) and horizontal (i.e. the upper teeth are positioned in front of the lower teeth) occlusion
Measured: 12months
Secondary outcomes (2)
Swallowing pattern
swallowing pattern (infant, adult or mixed)
Measured: 12 months
Articulation
articulation of l,n,d,t,s sounds.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open BiteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piotr Fudalej
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piotr Fudalej, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574490
- Sponsor's protocol ID
- 1072.6120.39.2024
- Acronym
- Myofunctional
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Myofunctional Therapy in Children With Open Bite - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06574490
- Acronym / sponsor ID
- Myofunctional / 1072.6120.39.2024
- Conditions
- Open Bite
- Keywords
- open bite, child, myofunctional, myotherapy, exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Piotr FudalejUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 28 Aug 2024 (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 goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective.
Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year.
Participants will exercise according to a pre-established regimen and schedule
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofunctional + | Experimental | Procedure: Myofunctional therapy (+)A series of myofunctional exercises |
| Myofunctional - | Active comparator | Procedure: Myofunctional therapy (-)No exercises |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- generally healthy children aged 6-10 years,
- infant swallowing type,
- open anterior occlusion (i.e. no contact between the maxillary and mandibular medial incisors),
- mixed dentition
Key exclusion criteria (8 listed)
- finger sucking habit (or similar) occurring within the last 6 months,
- previous myofunctional therapy,
- upper airway obstruction,
- congenital craniofacial developmental disorder,
- connective tissue or muscle disease,
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 |
|---|---|---|
| Myofunctional therapy (+)A series of myofunctional exercises performed in 10-20 sessions over 6 months | Procedure or surgery | Myofunctional + |
| Myofunctional therapy (-)NO exercises; A series of myofunctional exercises performed in 10-20 sessions over 6 months is delayed by 1 year | Procedure or surgery | Myofunctional - |
Primary outcome
Overbite
Time frame: 12months
presence positive vertical (i.e. the upper teeth overlap the lower teeth) and horizontal (i.e. the upper teeth are positioned in front of the lower teeth) occlusion
2 secondary outcomes
Swallowing pattern
Time frame: 12 months
Articulation
Time frame: 12 months
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 28 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Myofunctional therapy (+) and Myofunctional therapy (-) in people with Open Bite, run by Piotr Fudalej.
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 4 inclusion and 8 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 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overbite (time frame: 12months). 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 28 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.