- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962766
Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
March 27, 2024 updated by: Nelly Huynh, Université de Montréal
The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3V 1H9
- Clinique d'orthodontie - Université de Montréal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: complete myofunctionnal therapy
complete therapy (at least 5 sessions) to correct their swallowing pattern and tongue position
|
|
Experimental: instructions
instructions to modify their tongue position (1 session)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
respiration mode
Time Frame: 6 months following therapy
|
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
|
6 months following therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tongue resting position
Time Frame: 6 months following therapy
|
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
|
6 months following therapy
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
swallowing pattern
Time Frame: 6 months following therapy
|
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
|
6 months following therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 10, 2013
First Submitted That Met QC Criteria
October 11, 2013
First Posted (Estimated)
October 14, 2013
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NH-13-OP-DegluLang
- 13-104-CERES-P (Other Identifier: UMontreal - CERES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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