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

PAIN Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855113
• Other study ID #: 13-031-CERES-D
• Status: Completed
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2021
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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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Related Conditions & MeSH terms

• PAIN

Intervention

Device:
• Invisalign

Locations

Country	Name	City	State
Canada	clinique d'orthodontie de l'Université de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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