COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
Recruitment status was: Not yet recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS|
- PAIN DURING INVISALIGN TREATMENT [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]
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).
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
those with an Invisalign® Treatment for orthodontic correction
those with braces for orthodontic correction.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01855113
|clinique d'orthodontie de l'Université de Montréal|
|Montreal, Quebec, Canada, H3V1H9|
|Study Director:||Hicham EL-Khatib, DMD,MSc||Université de Montreal|