BruxismNCT01812850
Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
An observational study of Bruxism, run by Université de Montréal at 1 site in Canada.
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®. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients are recruited from the Department of Orthodontics of the University of Montreal
Who may be able to join
- 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
Show all 10Show fewer
- In good health
- Patient and parents accept and sign informed consent form.
- Periodontal health permits orthodontic treatment
- Adequate oral hygiene
Who cannot join
- Diagnosed TMJ's dysfunction
- Severe TMJ's dysfunction
- Lack of attendance
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Orthodontics of the University of Montreal
Montreal, Quebec, H3V1H9
About this study
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).
Read the 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.
- Conditions
- Bruxism
- Keywords
- Temporomandibular joint, Orofacial muscular complex, Bruxism, Clenching, Orthodontic treatment, Invisalign®
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Invisalign® | All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex
RDC/TMD Research Diagnostic Criteria Method
Measured: 6 months
Secondary outcomes (2)
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
Measured: 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrée Montpetit, Université de Montréal
- Investigators
- Jennifer Brien, DMD, Principal investigatorAndrée Montpetit, DMD, MSc, Study directorNelly Huynh, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812850
- Sponsor's protocol ID
- 13-024-CERES-D
- Status last verified
- May 2016
- First submitted
- 13 Mar 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
- ClinicalTrials.gov ID
- NCT01812850
- Acronym / sponsor ID
- 13-024-CERES-D
- Conditions
- Bruxism
- Keywords
- Temporomandibular joint, Orofacial muscular complex, Bruxism, Clenching, Orthodontic treatment, Invisalign®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invisalign® | – | –All subjects in the study (estimation of 40 subjects) will be treated using the Invisalign® appliance. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients are recruited from the Department of Orthodontics of the University of Montreal
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (3 listed)
- Diagnosed TMJ's dysfunction
- Severe TMJ's dysfunction
- Lack of attendance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Effects of the continuous wear of Invisalign® trays on the number of bruxism/clenching events during sleep
Time frame: 6 months
Effects of the continuous wear of Invisalign® trays on the reported amount of bruxism/clenching during the day
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Brien, DMD principal investigator
Andrée Montpetit, DMD, MSc study director
Nelly Huynh, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.