Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-04-18 @ 4:41 AM
Study NCT ID:
NCT01962766
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009058', 'term': 'Mouth Breathing'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'swallowing pattern', 'timeFrame': '6 months following therapy', 'description': 'orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position'}], 'primaryOutcomes': [{'measure': 'respiration mode', 'timeFrame': '6 months following therapy', 'description': 'orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position'}], 'secondaryOutcomes': [{'measure': 'tongue resting position', 'timeFrame': '6 months following therapy', 'description': 'orthophonist speech assessment, including nasal or mouth respiration, swallowing pattern and tongue resting position'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mouth Breathing', 'Atypic Swallowing', 'Low Resting Position of Tongue']}, 'descriptionModule': {'briefSummary': 'The current research project aims to study the efficacy of myofunctional therapy and its orthodontic long-term outcomes.', 'detailedDescription': '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?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 6 and 14 years old\n* Atypical or immature swallowing pattern and lower position of the tongue at rest\n* Be an orthodontic patient treated at the Faculty of Dentistry, Université de Montreal\n* Speak and understand French without assistance\n* Be in good health (without neurological or psychiatric syndrome)\n* Agree to participate and sign the consent form research\n\nExclusion Criteria:\n\n* Non compliance to clinical visits (eg too many missed visits)\n* Patients who had previous orthodontic treatments\n* Syndrome or known systemic disease (chronic cardiopulmonary or neuromuscular disease, dysmorphia, major craniofacial abnormalities)'}, 'identificationModule': {'nctId': 'NCT01962766', 'briefTitle': 'Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Myofunctionnal Therapy on Nasal Breathing and Orthodontic Corrections Stability', 'orgStudyIdInfo': {'id': 'NH-13-OP-DegluLang'}, 'secondaryIdInfos': [{'id': '13-104-CERES-P', 'type': 'OTHER', 'domain': 'UMontreal - CERES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'complete myofunctionnal therapy', 'description': 'complete therapy (at least 5 sessions) to correct their swallowing pattern and tongue position', 'interventionNames': ['Behavioral: Myofunctionnal therapy']}, {'type': 'EXPERIMENTAL', 'label': 'instructions', 'description': 'instructions to modify their tongue position (1 session)', 'interventionNames': ['Behavioral: instructions']}], 'interventions': [{'name': 'Myofunctionnal therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['complete myofunctionnal therapy']}, {'name': 'instructions', 'type': 'BEHAVIORAL', 'armGroupLabels': ['instructions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3V 1H9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Clinique d'orthodontie - Université de Montréal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant research professor', 'investigatorFullName': 'Nelly Huynh', 'investigatorAffiliation': 'Université de Montréal'}}}}