Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000652471p
Ethics application status
Not yet submitted
Date submitted
15/05/2016
Date registered
19/05/2016
Date last updated
19/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation into the effects of Light Emitting Diode (LED) mediated photobiomodulation on root resorption and the rate of orthodontic tooth movement
Scientific title
An investigation into the effects of Light Emitting Diode (LED) mediated photobiomodulation on root resorption and the rate of orthodontic tooth movement
Secondary ID [1] 289229 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Root resorption 298794 0
Condition category
Condition code
Oral and Gastrointestinal 298845 298845 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of a constant 150g orthodontic force will be applied to the first premolar teeth for a period of 4 weeks (using orthodontic fixed braces) which are, and are not also exposed to daily Light Emitting Diode light of 850nm wavelength using an FDA approved device for this purpose (OrthoPulse - Biolux Research [Vancouver Canada]).
This force will be applied to the first premolar on BOTH sides of the mouth, the only difference between the sides will be that one is exposed to daily 10minute exposures of light from the device in a single 10 minute application, which is self administered by the patient each day using the easy-to-use device (OrthoPulse). These devices are modified by the manufacturer to "sham" or "deactivate" one side of the light emitting diodes so as to only expose a single side to light. The patient and investigator will be unaware of which side is deactivated. An instructional video and personal 1 to 1 instruction on how to do use the device will be given to the patient at the commencement of the trial by the investigator who is a second year specialist orthodontic resident. Adherence will be monitored using a smartphone app which tracks device usage by downloading usage data from each participant's individual device.

After 4 weeks of constant 150g of orthodontic force and daily usage of the device throughout, the first premolar teeth will be extracted simultaneously by the same investigator, under Local Anaesthesia (these extractions are a necessary part of the patients treatment) and examined under a Micro-CT (computer tomography) scanner to investigate root resorption changes on the root surfaces and determine whether there are any differences between the left side extracted tooth, and the right side tooth.

After the above extractions are carried out, the space left behind will be closed orthodontically (using braces) by moving the adjacent teeth (canine and second premolar) toward each other until completely closed (approximately 8 weeks). During this orthodontic space closure phase, the patient will again use the device once per day, every day, for the entire 8 weeks. This is to investigate whether the application of light has any positive or negative effect on the rate of tooth movement. The rate of movement will be measured both clinically with digital calipers, and also by taking periodic impressions/moulds of the patients teeth (every 2 weeks - 5 impressions in total) and measuring the distance each tooth has moved throughout time. This data will be recorded for both the left and right sides, and compared.
Intervention code [1] 294763 0
Treatment: Devices
Comparator / control treatment
Split mouth study.
Patients undergoing intervention will be their own control. For example, Left side of mouth exposed to LED light, Right side not exposed.
Control group
Active

Outcomes
Primary outcome [1] 298316 0
Amount of root resorption present on roots of extracted first premolar teeth as measured by Micro-CT (Micro- Computed tomography) analysis of quantity and volume of resorption craters present on the root surfaces of the extracted teeth.
Timepoint [1] 298316 0
Teeth are extracted 4 weeks after the initiation of Force application with and without Light Emitting Diode light application
Secondary outcome [1] 323834 0
Rate of orthodontic space closure, as assessed by clinical observation using digital calipers to measure the size of the gap as it closes every 2 weeks, in addition to dental impressions taken at 2 weekly intervals for a period of 8 weeks in total. The dental impressions will be poured up in dental stone and measurements can be made off these models, and the rate of space closure can be calculated mathematically.
Timepoint [1] 323834 0
After extraction of first premolar teeth:
- Space closure achieved after 2 weeks of active space closure
- Space closure achieved after 4 weeks of active space closure
- Space closure achieved after 6 weeks of active space closure
- Space closure achieved after 8 weeks of active space closure (total space closure over 8 weeks)

Eligibility
Key inclusion criteria
* Need for bilateral maxillary first premolar extractions (necessitating moderate anchorage requirements) and fixed appliance treatment (braces).
* Permanent Dentition (adult teeth)
* Apexification (root formation) completed;
* Similar degree of minimal crowding on each side of the maxillary arch (upper jaw)
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* No previous orthodontic or orthopaedic treatment;
* No craniofacial anomaly present;
* No previous reported or observed dental treatment of the maxillary canines;
* No history of trauma, bruxism or parafunction;
* No past and present signs and symptoms of periodontal disease;
* No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All devices have one side deactivated LED lights, and one side active. There is no identification on the devices as to which sides are active or not.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
Date of last participant enrolment
Anticipated
1/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5799 0
Sydney Dental Hospital - Surry Hills

Funding & Sponsors
Funding source category [1] 293601 0
Hospital
Name [1] 293601 0
Sydney Dental Hospital
Country [1] 293601 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Level 2, Orthodontic Department
Sydney Dental Hospital, 2 Chalmers Street
Surry Hills, NSW 2010
Country
Australia
Secondary sponsor category [1] 292421 0
Charities/Societies/Foundations
Name [1] 292421 0
Australian Society of Orthodontists
Address [1] 292421 0
204 / 133 Alexander St Crows Nest NSW 2065
Country [1] 292421 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295040 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 295040 0
Research Ethics and Governance Office (REGO)
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 295040 0
Australia
Date submitted for ethics approval [1] 295040 0
01/06/2016
Approval date [1] 295040 0
Ethics approval number [1] 295040 0

Summary
Brief summary
The hypothesis of this research project is that LED (Light emitting diode) light (photobiomodulation) will minimise orthodontic root resorption while allowing an accelerated rate of orthodontic tooth movement (acceleration of tooth movement is claimed by the manufacturer).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65890 0
Prof M. Ali Darendeliler
Address 65890 0
University of Sydney/Sydney Dental Hospital
Orthodontics Department.
Level 2, 2 Chalmers St
Surry Hills
NSW
2010
Country 65890 0
Australia
Phone 65890 0
+61 2 9351 8314
Fax 65890 0
Email 65890 0
ali.darendeliler@sydney.edu.au
Contact person for public queries
Name 65891 0
Dr John Sambevski
Address 65891 0
University of Sydney/Sydney Dental Hospital
Orthodontics Department.
Level 2, 2 Chalmers St
Surry Hills
NSW
2010
Country 65891 0
Australia
Phone 65891 0
+61 2 9351 8314
Fax 65891 0
Email 65891 0
jsam9032@uni.sydney.edu.au
Contact person for scientific queries
Name 65892 0
Dr John Sambevski
Address 65892 0
University of Sydney/Sydney Dental Hospital
Orthodontics Department.
Level 2, 2 Chalmers St
Surry Hills
NSW
2010
Country 65892 0
Australia
Phone 65892 0
+61 2 9351 8314
Fax 65892 0
Email 65892 0
jsam9032@uni.sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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