Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex|
- Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex [ Time Frame: 6 months ] [ Designated as safety issue: No ]RDC/TMD Research Diagnostic Criteria Method
- Effects of the continuous wear of Invisalign® trays on the number of bruxism/clenching events during sleep [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evaluation of bruxism and clenching at night with electromyogram (EMG) recordings
- Effects of the continuous wear of Invisalign® trays on the reported amount of bruxism/clenching during the day [ Time Frame: 6 months ] [ Designated as safety issue: No ]Bruxism and clenching questionnaire developed by Dr Gilles Lavigne (1996)
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance.
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.
* Evaluation of the effect of continuous wear of Invisalign® trays on the TMJ and muscles of the orofacial complex.
- Objective evaluation of the effect of Invisalign® trays on bruxism/clenching events at night.
- Subjective evaluation of the effect of Invisalign® trays on bruxism/clenching during the day.
- Evaluation of the evolution of symptoms over the course of six months.
-Initial Exam (Initial complete orthodontic record)
Appointment 2 (T0):
- Presentation of the treatment plan
- Informed consent
- iTero Scan for Invisalign
- TMJ exam (baseline)
- Diagnostic bruxism/clenching questionnaire (baseline)
- Give Electromyogram (EMG) machine to patient for night study at home (baseline)
- Instructions on how to use the EMG machine
- NB: Patient returns EMG by courier
- Delivery of Invisalign® trays #1
- Instructions on wearing the Invisalign® trays
- Take mailing information to send EMG machine by courier (EMG recording the night before Appointment 4 / T1)
Appointment 4 (T1: 2 weeks after appointment 3):
- Patient brings back EMG machine
- TMJ exam
- Daytime bruxism/clenching questionnaire
- Bonding attachments onto teeth
- Give Invisalign® trays #2
- NB: Patient will be followed every 6-8 weeks
Appointment 5 (T2: 6 months after appointment 4):
- TMJ exam
- Daytime bruxism/clenching
- Give EMG machine for night study at home
- Patient returns EMG by courier
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01812850
|Contact: Jennifer Brien, DMDemail@example.com|
|Contact: Andrée Montpetit, DMD, MScfirstname.lastname@example.org|
|Department of Orthodontics of the University of Montreal||Not yet recruiting|
|Montreal, Quebec, Canada, H3V1H9|
|Contact: Jennifer Brien, DMD 514-343-6056 email@example.com|
|Contact: Andrée Montpetit, DMD, MSc 514-343-6056 firstname.lastname@example.org|
|Principal Investigator:||Jennifer Brien, DMD|
|Study Director:||Andrée Montpetit, DMD, MSc|
|Study Director:||Nelly Huynh, PhD|