Mouth BreathingNCT01962766
Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
A study testing Myofunctionnal therapy and instructions in people with Mouth Breathing and Atypic Swallowing, run by Université de Montréal at 1 site in Canada.
Trial summary
The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Breathing, Atypic Swallowing, Low Resting Position of Tongue
- What is being tested?
- Myofunctionnal therapy and instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 6 and 14 years old
- Atypical or immature swallowing pattern and lower position of the tongue at rest
- Be an orthodontic patient treated at the Faculty of Dentistry, Université de Montreal
- Speak and understand French without assistance
- Be in good health (without neurological or psychiatric syndrome)
- Agree to participate and sign the consent form research
Who cannot join
- Non compliance to clinical visits (eg too many missed visits)
- Patients who had previous orthodontic treatments
- Syndrome or known systemic disease (chronic cardiopulmonary or neuromuscular disease, dysmorphia, major craniofacial abnormalities)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique d'orthodontie - Université de Montréal
Montreal, Quebec, H3V 1H9
About this study
The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes.
Read the detailed description
The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes, such as: 1) Is treating a low tongue position and lip closure at rest sufficient for orthodontic short and long-term outcomes? 2) Does treating atypical swallowing along with an incorrect tongue position help achieve and maintain higher outcomes of the myofucntional and orthodontic treatments?
- Being tested
- Myofunctionnal therapy, instructions
- Medical subject headings
- Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctionnal therapyBehavioural
instructionsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| complete myofunctionnal therapy | Active comparator | complete therapy (at least 5 sessions) to correct their swallowing pattern and tongue position Receives: Behavioral: Myofunctionnal therapy |
| instructions | Experimental | instructions to modify their tongue position (1 session) Receives: Behavioral: instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiration mode
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
Measured: 6 months following therapy
Secondary outcomes (1)
tongue resting position
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
Measured: 6 months following therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth BreathingStudies 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelly Huynh, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962766
- Sponsor's protocol ID
- NH-13-OP-DegluLang
- Other IDs
- 13-104-CERES-P
- Status last verified
- Mar 2024
- First submitted
- 10 Oct 2013
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
- ClinicalTrials.gov ID
- NCT01962766
- Acronym / sponsor ID
- NH-13-OP-DegluLang
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Oct 2013 (estimated)
- 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 current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes.
Detailed description
The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes, such as: 1) Is treating a low tongue position and lip closure at rest sufficient for orthodontic short and long-term outcomes? 2) Does treating atypical swallowing along with an incorrect tongue position help achieve and maintain higher outcomes of the myofucntional and orthodontic treatments?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete myofunctionnal therapy | Active comparator | Behavioral: Myofunctionnal therapycomplete therapy (at least 5 sessions) to correct their swallowing pattern and tongue position |
| instructions | Experimental | Behavioral: instructionsinstructions to modify their tongue position (1 session) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Between 6 and 14 years old
- Atypical or immature swallowing pattern and lower position of the tongue at rest
- Be an orthodontic patient treated at the Faculty of Dentistry, Université de Montreal
- Speak and understand French without assistance
- Be in good health (without neurological or psychiatric syndrome)
Key exclusion criteria (3 listed)
- Non compliance to clinical visits (eg too many missed visits)
- Patients who had previous orthodontic treatments
- Syndrome or known systemic disease (chronic cardiopulmonary or neuromuscular disease, dysmorphia, major craniofacial abnormalities)
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 |
|---|---|---|
| Myofunctionnal therapy | Behavioural | complete myofunctionnal therapy |
| instructions | Behavioural | instructions |
Primary outcome
respiration mode
Time frame: 6 months following therapy
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
1 secondary outcome
tongue resting position
Time frame: 6 months following therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofunctionnal therapy and instructions in people with Mouth Breathing and Atypic Swallowing, run by Université de Montréal at 1 site in Canada.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
respiration mode (time frame: 6 months following therapy). 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 29 Mar 2024.