PAINNCT01855113
COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
An observational study of PAIN, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- PAIN
- What is being tested?
- Invisalign
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients are recruited from the Department of Orthodontics at the University of Montreal.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site
clinique d'orthodontie de l'Université de Montréal
Montreal, Quebec, H3V1H9
About this study
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.
Read the 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.
- Conditions
- PAIN
- Being tested
- Invisalign
- Keywords
- PAIN, ORTHODONTIC TREATMENT, INVISALIGN
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvisalignDevice
| Study group | Role | What they receive |
|---|---|---|
| INVISALIGN® | those with an Invisalign® Treatment for orthodontic correction Receives: Device: Invisalign | |
| braces | those with braces for orthodontic correction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAINStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hicham El-Khatib, Université de Montréal
- Investigators
- Hicham EL-Khatib, DMD,MSc, Study director, Université de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855113
- Sponsor's protocol ID
- 13-031-CERES-D
- Status last verified
- Sep 2021
- First submitted
- 13 Mar 2013
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
- ClinicalTrials.gov ID
- NCT01855113
- Acronym / sponsor ID
- 13-031-CERES-D
- Conditions
- PAIN
- Keywords
- PAIN, ORTHODONTIC TREATMENT, INVISALIGN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INVISALIGN® | – | Device: Invisalignthose with an Invisalign® Treatment for orthodontic correction |
| braces | – | –those with braces for orthodontic correction. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients are recruited from the Department of Orthodontics at the University of Montreal.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invisalign | Device | INVISALIGN® |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicham EL-Khatib, DMD,MSc study director
Université de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PAIN, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN DURING INVISALIGN TREATMENT (time frame: 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.