- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01812850
Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
Study Overview
Status
Conditions
Detailed Description
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:
- 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.
Appointment 1:
-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
Appointment 3:
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Quebec
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Montreal, Quebec, Canada, H3V1H9
- Department of Orthodontics of the University of Montreal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Permanent dentition
- No congenially permanent teeth missing (with the exception of 3rd molars)
- Patient requiring a non-extraction orthodontic treatment
- Patient followed by the University of Montreal port-graduate orthodontic clinic
- Cl.I skeletal relation (or mild cl.II / mild cl.III)
- Patient can speak and read french
- In good health
- Patient and parents accept and sign informed consent form.
- Periodontal health permits orthodontic treatment
- Adequate oral hygiene
Exclusion Criteria:
- Diagnosed TMJ's dysfunction
- Severe TMJ's dysfunction
- Lack of attendance
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Invisalign®
All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
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)
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Brien, DMD
- Study Director: Andrée Montpetit, DMD, MSc
- Study Director: Nelly Huynh, PhD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-024-CERES-D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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