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

NCT ID: NCT01855113

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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

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PAIN

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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INVISALIGN®

those with an Invisalign® Treatment for orthodontic correction

Invisalign

Intervention Type DEVICE

braces

those with braces for orthodontic correction.

No interventions assigned to this group

Interventions

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Invisalign

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Hicham El-Khatib

Associate professor, Doctor of Dental Medecine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hicham EL-Khatib, DMD,MSc

Role: STUDY_DIRECTOR

Université de Montreal

Locations

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clinique d'orthodontie de l'Université de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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13-031-CERES-D

Identifier Type: -

Identifier Source: org_study_id

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