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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Université de Montréal
Sponsor:
Information provided by (Responsible Party):
Hicham El-Khatib, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01855113
First received: March 13, 2013
Last updated: May 13, 2013
Last verified: March 2013
  Purpose

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.


Condition
PAIN

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • 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).



Estimated Enrollment: 60
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)
Groups/Cohorts
INVISALIGN®
those with an Invisalign® Treatment for orthodontic correction
braces
those with braces for orthodontic correction.

Detailed 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.
  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are recruited from the Department of Orthodontics at the University of Montreal.

Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855113

Contacts
Contact: claire Damois, DMD 5149958165 Clairemasidamois@gmail.com

Locations
Canada, Quebec
clinique d'orthodontie de l'Université de Montréal Not yet recruiting
Montreal, Quebec, Canada, H3V1H9
Sponsors and Collaborators
Université de Montréal
Investigators
Study Director: Hicham EL-Khatib, DMD,MSc Université de Montreal
  More Information

No publications provided

Responsible Party: Hicham El-Khatib, Associate professor, Doctor of Dental Medecine, Université de Montréal
ClinicalTrials.gov Identifier: NCT01855113     History of Changes
Other Study ID Numbers: 13-031-CERES-D
Study First Received: March 13, 2013
Last Updated: May 13, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Montréal:
PAIN
ORTHODONTIC TREATMENT
INVISALIGN

ClinicalTrials.gov processed this record on July 28, 2014