COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01855113|
Recruitment Status : Unknown
Verified March 2013 by Hicham El-Khatib, Université de Montréal.
Recruitment status was: Not yet recruiting
First Posted : May 16, 2013
Last Update Posted : May 16, 2013
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||June 2014|
those with an Invisalign® Treatment for orthodontic correction
those with braces for orthodontic correction.
- PAIN DURING INVISALIGN TREATMENT [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|