NCT01812850

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

March 13, 2013

Last Update Submit

May 10, 2016

Conditions

Bruxism

Keywords

Temporomandibular jointOrofacial muscular complexBruxismClenchingOrthodontic treatmentInvisalign®

Outcome Measures

Primary Outcomes (1)

  • Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex

    RDC/TMD Research Diagnostic Criteria Method

    6 months

Secondary Outcomes (2)

  • Effects of the continuous wear of Invisalign® trays on the number of bruxism/clenching events during sleep

    6 months

  • Effects of the continuous wear of Invisalign® trays on the reported amount of bruxism/clenching during the day

    6 months

Study Arms (1)

Invisalign®

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

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosed TMJ's dysfunction
  • Severe TMJ's dysfunction
  • Lack of attendance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics of the University of Montreal

Montreal, Quebec, H3V1H9, Canada

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Officials

  • Jennifer Brien, DMD

    PRINCIPAL INVESTIGATOR

  • Andrée Montpetit, DMD, MSc

    STUDY DIRECTOR

  • Nelly Huynh, PhD

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Doctor of Dental Medecine

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 18, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

May 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

CA(1)