CompletedNCT01855113Updated Oct 4, 2021

COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS

An observational study in PAIN, sponsored by Université de Montréal. Completed at 1 site in Canada. Open to participants aged 12 Years to 30 Years. Per ClinicalTrials.gov, last updated 2021-10-04.

Sponsored by Université de Montréal · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 31
Ages: 12 Years to 30 Years
Sex: All

Study summary

This study aims to compare the pain experienced by patients undergoing orthodontic treatment with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment with conventional braces. Because the aligners are removable, nearly invisible and don't involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign Treatment and less affectation of the quality of life.

Read the detailed description

The aims of the study are to determine:

the presence of pain, the magnitude of pain, the duration of pain, and the location of pain.

The hypotheses of this study are:

Treatment with Invisalign ® aligners result in less pain than the braces
Treatment with Invisalign ® aligners result in less irritation to the soft tissues with braces
Pain should increase each time the aligners are put in the mouse and decrease until disappearing on the third day.
The quality of life will be most affected by treatment with braces than with Invisalign ®.
Null Hypothesis: There is no difference at all points between the two treatments.

Conditions studied

PAIN

Keywords

PAIN
ORTHODONTIC TREATMENT
INVISALIGN

In context

Lead sponsor

Université de Montréal is the lead sponsor of 97 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 30 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

In permanent dentition;
Age less than 30 years;
No medical contraindications or presence of systemic diseases (including nervous system disorders);
No missing teeth except the third molars;
Orthodontic treatment without extraction.
Relationship skeletal cl. I (or slightly cl. II or cl. III)
Speak and understand French without help.

Exclusion Criteria: lack of compliance with appointments.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 31 participants (actual)
Patient registry: No

Groups and cohorts

INVISALIGN®
those with an Invisalign® Treatment for orthodontic correction
Device: Invisalign
braces
those with braces for orthodontic correction.

Interventions

DeviceInvisalign

What researchers measure

Primary outcomes

PAIN DURING INVISALIGN TREATMENT
A questionnaire will be completed by the patient at different time points during treatment. This questionnaire includes questions on descriptive pain: location, duration, alteration in quality of life and a visual analog scale (VAS).
Time frame: 6 MONTHS

Study locations

1 site

clinique d'orthodontie de l'Université de Montréal
Montreal, Quebec H3V1H9, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01855113
Lead sponsor: Université de Montréal
Responsible party: Hicham El-Khatib (Associate professor, Doctor of Dental Medecine, Université de Montréal) — Principal investigator
First posted: May 16, 2013
Start date: Jun 2013
Primary completion: Jun 2015
Completion: Jun 2015
Last update: Oct 4, 2021

Study contacts

Hicham EL-Khatib, DMD,MSc

study director · Université de Montreal

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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