Back to resultsMyofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
Primary Purpose
Mouth Breathing, Atypic Swallowing, Low Resting Position of Tongue
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Myofunctionnal therapy
instructions
Sponsored by
About this trial
This is an interventional treatment trial for Mouth Breathing
Eligibility Criteria
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)
Sites / Locations
- Clinique d'orthodontie - Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
complete myofunctionnal therapy
instructions
Arm Description
complete therapy (at least 5 sessions) to correct their swallowing pattern and tongue position
instructions to modify their tongue position (1 session)
Outcomes
Primary Outcome Measures
respiration mode
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
Secondary Outcome Measures
tongue resting position
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01962766
Brief Title
Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
Official Title
Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth Breathing, Atypic Swallowing, Low Resting Position of Tongue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
complete myofunctionnal therapy
Arm Type
Active Comparator
Arm Description
complete therapy (at least 5 sessions) to correct their swallowing pattern and tongue position
Arm Title
instructions
Arm Type
Experimental
Arm Description
instructions to modify their tongue position (1 session)
Intervention Type
Behavioral
Intervention Name(s)
Myofunctionnal therapy
Intervention Type
Behavioral
Intervention Name(s)
instructions
Primary Outcome Measure Information:
Title
respiration mode
Description
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
Time Frame
6 months following therapy
Secondary Outcome Measure Information:
Title
tongue resting position
Description
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
Time Frame
6 months following therapy
Other Pre-specified Outcome Measures:
Title
swallowing pattern
Description
orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position
Time Frame
6 months following therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Clinique d'orthodontie - Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3V 1H9
Country
Canada
12. IPD Sharing Statement
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Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
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