Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|