NCT01962766

Brief Summary

The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

October 10, 2013

Last Update Submit

March 27, 2024

Conditions

Mouth BreathingAtypic SwallowingLow Resting Position of Tongue

Outcome Measures

Primary Outcomes (1)

  • respiration mode

    orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position

    6 months following therapy

Secondary Outcomes (1)

  • tongue resting position

    6 months following therapy

Other Outcomes (1)

  • swallowing pattern

    6 months following therapy

Study Arms (2)

complete myofunctionnal therapy

ACTIVE COMPARATOR

complete therapy (at least 5 sessions) to correct their swallowing pattern and tongue position

Behavioral: Myofunctionnal therapy

instructions

EXPERIMENTAL

instructions to modify their tongue position (1 session)

Behavioral: instructions

Interventions

Myofunctionnal therapyBEHAVIORAL
complete myofunctionnal therapy
instructionsBEHAVIORAL
instructions

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique d'orthodontie - Université de Montréal

Montreal, Quebec, H3V 1H9, Canada

Location

MeSH Terms

Conditions

Mouth Breathing

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant research professor

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 14, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations

CA(1)