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OpenTrials
Completed

NCT Number: NCT01855113

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

clinique d'orthodontie de l'Université de Montréal

Montreal, Quebec, H3V1H9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Invisalign

Device

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 16, 2013
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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