The Rate or Orthodontic Tooth MovementNCT01490385
The Effect of Light Emitting Diode Phototherapy on the Rate of Orthodontic Tooth Movement - A Clinical Study
A study testing LED Phototherapy in people with The Rate or Orthodontic Tooth Movement, run by Bryan Tompson at 1 site in Canada.
Trial summary
LED Phototherapy will increase the velocity of Orthodontic tooth movement. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Rate or Orthodontic Tooth Movement
- What is being tested?
- LED Phototherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jul 2013
- Phase
- Interventional
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- bilaterally symmetric extraction of premolar teeth with residual extraction spaces large enough to ensure space closure is not complete prior to the subsequent orthodontic appointment
- no medicines or systemic illness
- full banding/bonding of teeth
Who cannot join
- pregnant
- non-extraction treatment
- systemic illness
- prior orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Faculty of Dentistry
Toronto, Ontario, M5G1G6
About this study
LED Phototherapy will increase the velocity of Orthodontic tooth movement.
- Conditions
- The Rate or Orthodontic Tooth Movement
- Being tested
- LED Phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED PhototherapyDevice
Also called Device manufactured by Biolux Research Ltd
| Study group | Role | What they receive |
|---|---|---|
| LED Phototherapy | Active comparator | LED phototherapy will be delivered transdermally via an extra-oral device and in a split mouth manner (half of the dental arch). Receives: Device: LED Phototherapy |
| Control: conventional orthodontic tooth movement | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extraction space size
T0=the start of active extraction space closure T1=3-7 weeks after T0 T2=4-7 weeks after T1
Measured: T0, T1, T2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Rate or Orthodontic Tooth MovementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryan Tompson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bryan Tompson, University of Toronto
- Investigators
- Bryan D Tompson, DDS, DipPaedo, DipOrtho, FRCDC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490385
- Sponsor's protocol ID
- 11-12-2
- Status last verified
- Dec 2013
- First submitted
- 10 Nov 2011
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung SE, Tompson B, Gong SG. The effect of light emitting diode phototherapy on rate of orthodontic tooth movement: a split mouth, controlled clinical trial. J Orthod. 2015;42(4):274-83. doi: 10.1179/1465313315Y.0000000013. Epub 2015 Jul 28.
PubMed 26216550
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Light Emitting Diode Phototherapy on the Rate of Orthodontic Tooth Movement - A Clinical Study
- ClinicalTrials.gov ID
- NCT01490385
- Acronym / sponsor ID
- 11-12-2
- Conditions
- The Rate or Orthodontic Tooth Movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Bryan TompsonUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Dec 2011 (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.
LED Phototherapy will increase the velocity of Orthodontic tooth movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LED Phototherapy | Active comparator | Device: LED PhototherapyLED phototherapy will be delivered transdermally via an extra-oral device and in a split mouth manner (half of the dental arch). |
| Control: conventional orthodontic tooth movement | No intervention | – |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- bilaterally symmetric extraction of premolar teeth with residual extraction spaces large enough to ensure space closure is not complete prior to the subsequent orthodontic appointment
- no medicines or systemic illness
- full banding/bonding of teeth
Key exclusion criteria (4 listed)
- pregnant
- non-extraction treatment
- systemic illness
- prior orthodontic treatment
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 |
|---|---|---|
| LED PhototherapyAlso: Device manufactured by Biolux Research Ltd | Device | LED Phototherapy |
Primary outcome
Extraction space size
Time frame: T0, T1, T2
T0=the start of active extraction space closure T1=3-7 weeks after T0 T2=4-7 weeks after T1
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 17 Dec 2013.
- Derived from this study: PubMed 26216550Chung SE, Tompson B, Gong SG. The effect of light emitting diode phototherapy on rate of orthodontic tooth movement: a split mouth, controlled clinical trial. J Orthod. 2015;42(4):274-83. doi: 10.1179/1465313315Y.0000000013. Epub 2015 Jul 28.
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.
Bryan D Tompson, DDS, DipPaedo, DipOrtho, FRCDC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED Phototherapy in people with The Rate or Orthodontic Tooth Movement, run by Bryan Tompson 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 3 inclusion and 4 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 17 Dec 2013. 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?
Extraction space size (time frame: T0, T1, T2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01490385, which also lists 1 linked publication.
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 17 Dec 2013.