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

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.

Study Overview

• Status: Completed
• Conditions: PAIN
• Intervention / Treatment: Device: Invisalign

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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
INVISALIGN®; those with an Invisalign® Treatment for orthodontic correction	Device: Invisalign
braces; those with braces for orthodontic correction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 MONTHS

Collaborators and Investigators

• Sponsor: Université de Montréal
• Investigators: Study Director: Hicham EL-Khatib, DMD,MSc, Université de Montréal

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: PAIN; ORTHODONTIC TREATMENT; INVISALIGN
• Other Study ID Numbers: 13-031-CERES-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No