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

Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01812850
• Other study ID #: 13-024-CERES-D
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2013
• Last updated: April 3, 2013
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2013
• Source: Université de Montréal
• Contact: Jennifer Brien, DMD
• Phone: 514-343-6056
• Email: jennifer.brien[@]umontreal.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bruxism

Locations

Country	Name	City	State
Canada	Department of Orthodontics of the University of Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex	RDC/TMD Research Diagnostic Criteria Method	6 months	No
Secondary	Effects of the continuous wear of Invisalign® trays on the number of bruxism/clenching events during sleep	Evaluation of bruxism and clenching at night with electromyogram (EMG) recordings	6 months	No
Secondary	Effects of the continuous wear of Invisalign® trays on the reported amount of bruxism/clenching during the day	Bruxism and clenching questionnaire developed by Dr Gilles Lavigne (1996)	6 months	No