Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
|ClinicalTrials.gov Identifier: NCT01812850|
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : May 12, 2016
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||May 2015|
All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance.
- Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex [ Time Frame: 6 months ]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 ]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 ]Bruxism and clenching questionnaire developed by Dr Gilles Lavigne (1996)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812850
|Department of Orthodontics of the University of Montreal|
|Montreal, Quebec, Canada, H3V1H9|
|Principal Investigator:||Jennifer Brien, DMD|
|Study Director:||Andrée Montpetit, DMD, MSc|
|Study Director:||Nelly Huynh, PhD|