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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
Sponsor:
Information provided by (Responsible Party):
Andrée Montpetit, Université de Montréal

Tracking Information
First Submitted Date March 13, 2013
First Posted Date March 18, 2013
Last Update Posted Date May 12, 2016
Study Start Date April 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01812850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 13, 2013)
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
Official Title Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
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).
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients are recruited from the Department of Orthodontics of the University of Montreal
Condition Bruxism
Intervention Not Provided
Study Groups/Cohorts Invisalign®
All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: March 13, 2013)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01812850
Other Study ID Numbers 13-024-CERES-D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andrée Montpetit, Université de Montréal
Study Sponsor Université de Montréal
Collaborators Not Provided
Investigators
Principal Investigator: Jennifer Brien, DMD
Study Director: Andrée Montpetit, DMD, MSc
Study Director: Nelly Huynh, PhD
PRS Account Université de Montréal
Verification Date May 2016