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The purpose of this study is to assess temporomandibular joint (TMJ) symptoms and night muscle activity in an objective manner, in addition to daytime bruxism and clenching, as reported by the patient, following the start of orthodontic treatment with Invisalign®. A baseline evaluation of all measures will be used as control data, while different time points will be used to evaluate the evolution of patients' symptoms over the course of six months (the duration of the study).
The aim of the study is to evaluate the effects of orthodontic treatment using Invisalign® on the temporomandibular joint (TMJ) and orofacial muscular complex, on the recorded number of bruxism/clenching events during sleep, and on the reported amount of bruxism/clenching events during the day.
Principal objective:
* Evaluation of the effect of continuous wear of Invisalign® trays on the TMJ and muscles of the orofacial complex.
Secondary objectives:
Appointment 1:
-Initial Exam (Initial complete orthodontic record)
Appointment 2 (T0):
Appointment 3:
Appointment 4 (T1: 2 weeks after appointment 3):
Appointment 5 (T2: 6 months after appointment 4):
All subjects in the study will be treated using the Invisalign® appliance. To obtain statistically and clinically significant results, it was calculated that at least 30 patients will need to complete the study. Our objective is to recruit about 40 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invisalign® | All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex | RDC/TMD Research Diagnostic Criteria Method | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of the continuous wear of Invisalign® trays on the number of bruxism/clenching events during sleep | Evaluation of bruxism and clenching at night with electromyogram (EMG) recordings | 6 months |
| Effects of the continuous wear of Invisalign® trays on the reported amount of bruxism/clenching during the day |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are recruited from the Department of Orthodontics of the University of Montreal
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Brien, DMD | Principal Investigator | |
| Andrée Montpetit, DMD, MSc | Study Director | |
| Nelly Huynh, PhD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthodontics of the University of Montreal | Montreal | Quebec | H3V1H9 | Canada |
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| ID | Term |
|---|---|
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
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Bruxism and clenching questionnaire developed by Dr Gilles Lavigne (1996) |
| 6 months |