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

May 10, 2016 updated by: Andrée Montpetit, Université de Montréal
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).

Study Overview

Status

Completed

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

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H3V1H9
        • Department of Orthodontics of the University of Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are recruited from the Department of Orthodontics of the University of Montreal

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jennifer Brien, DMD
  • Study Director: Andrée Montpetit, DMD, MSc
  • Study Director: Nelly Huynh, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

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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