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Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex

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ClinicalTrials.gov Identifier: NCT01812850
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease
Bruxism

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 Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
Study Start Date : April 2013
Primary Completion Date : January 2015
Study Completion Date : May 2015
Groups and Cohorts

Group/Cohort
Invisalign®
All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients are recruited from the Department of Orthodontics of the University of Montreal
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Canada, Quebec
Department of Orthodontics of the University of Montreal
Montreal, Quebec, Canada, H3V1H9
Sponsors and Collaborators
Université de Montréal
Investigators
Principal Investigator: Jennifer Brien, DMD
Study Director: Andrée Montpetit, DMD, MSc
Study Director: Nelly Huynh, PhD
More Information

Responsible Party: Andrée Montpetit, Assistant professor, Doctor of Dental Medecine, Université de Montréal
ClinicalTrials.gov Identifier: NCT01812850     History of Changes
Other Study ID Numbers: 13-024-CERES-D
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Andrée Montpetit, Université de Montréal:
Temporomandibular joint
Orofacial muscular complex
Bruxism
Clenching
Orthodontic treatment
Invisalign®

Additional relevant MeSH terms:
Bruxism
Tooth Diseases
Stomatognathic Diseases