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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrée Montpetit, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01812850
First received: March 13, 2013
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
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
Bruxism

Study Type: Observational
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

Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: April 2013
Study Completion Date: May 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Invisalign®
All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: March 13, 2013
Last Updated: May 10, 2016
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Bruxism
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2016