NCT01490385

Brief Summary

LED Phototherapy will increase the velocity of Orthodontic tooth movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

November 10, 2011

Last Update Submit

December 15, 2013

Conditions

The Rate or Orthodontic Tooth Movement

Outcome Measures

Primary Outcomes (1)

  • Extraction space size

    T0=the start of active extraction space closure T1=3-7 weeks after T0 T2=4-7 weeks after T1

    T0, T1, T2

Study Arms (2)

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).

Device: LED Phototherapy

Control: conventional orthodontic tooth movement

NO INTERVENTION

Interventions

LED PhototherapyDEVICE
Also known as: Device manufactured by Biolux Research Ltd
LED Phototherapy

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnant
  • non-extraction treatment
  • systemic illness
  • prior orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto, Faculty of Dentistry

Toronto, Ontario, M5G1G6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26216550DERIVED

Study Officials

  • Bryan D Tompson, DDS, DipPaedo, DipOrtho, FRCDC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head, Discipline of Orthodontics

Study Record Dates

First Submitted

November 10, 2011

First Posted

December 13, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

CA(1)