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 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
|Contact: claire Damois, DMD||5149958165||Clairemasidamois@gmail.com|
|clinique d'orthodontie de l'Université de Montréal||Not yet recruiting|
|Montreal, Quebec, Canada, H3V1H9|
|Study Director:||Hicham EL-Khatib, DMD,MSc||Université de Montreal|