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

Completed

• Conditions: PAIN
• Interventions: Device: Invisalign

• Registration Number: NCT01855113
• Lead Sponsor: Université de Montréal

Brief 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.

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 Timeline

• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Study Start: 2013-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
INVISALIGN®	Invisalign	those with an Invisalign® Treatment for orthodontic correction

Primary Outcome Measures

Name	Time	Method
PAIN DURING INVISALIGN TREATMENT	6 MONTHS	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).

Trial Locations

Locations (1)

clinique d'orthodontie de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada