NCT01855113

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

March 13, 2013

Last Update Submit

September 27, 2021

Conditions

PAIN

Keywords

PAINORTHODONTIC TREATMENTINVISALIGN

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

INVISALIGN®

those with an Invisalign® Treatment for orthodontic correction

Device: Invisalign

braces

those with braces for orthodontic correction.

Interventions

InvisalignDEVICE
INVISALIGN®

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

clinique d'orthodontie de l'Université de Montréal

Montreal, Quebec, H3V1H9, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Orthodontic Appliances, Removable

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Hicham EL-Khatib, DMD,MSc

    Université de Montreal

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Doctor of Dental Medecine

Study Record Dates

First Submitted

March 13, 2013

First Posted

May 16, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

CA(1)