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Trial registered on ANZCTR


Registration number
ACTRN12619001237178
Ethics application status
Approved
Date submitted
26/08/2019
Date registered
6/09/2019
Date last updated
6/09/2019
Date data sharing statement initially provided
6/09/2019
Date results provided
6/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a clinically feasible application of low-level laser therapy on the rate of orthodontic tooth movement: A triple-blinded randomized controlled clinical trial.
Scientific title
The effects of a clinically feasible application of low-level laser therapy on the rate of orthodontic tooth movement: A triple-blinded randomized controlled clinical trial.
Secondary ID [1] 298928 0
Nil known
Universal Trial Number (UTN)
U1111-1239-2369
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rate of orthodontic tooth movement 314166 0
Condition category
Condition code
Alternative and Complementary Medicine 312535 312535 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 312611 312611 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maxillary first premolars were extracted. Patients were then bonded with self-ligating orthodontic SPEED brackets. A standardised wire sequence of 0.014-inch or 0.016-inch nickel titanium (NiTi) for 8 weeks, 0.018 x 0.018-inch 3t Tri-Tanium Memory wire for 8 weeks and 0.019 x 0.025-inch beta-titanium molybdenum for 8 weeks was used to achieve levelling and alignment. Anchorage was established using a transpalatal arch from the second molars and reinforced with consolidation of the second premolars, first and second molars using a 0.010-inch stainless steel ligature tie on either side. Canine retraction commenced on an 0.020-inch stainless steel wire using medium super-elastic NiTi closed coil springs attached to 5mm powerarms from the canine to the first molar. The NiTi coils were set to deliver 150g force, determined using a calibrated spring gauge and verified at each appointment. Occlusal stops were placed on the first molars to prevent any occlusal interference during retraction.
The primary investigator (DM) carried out the intervention. This investigator is a dentist and attended a training course to safely use the laser therapy unit.
An aluminium gallium arsenide laser 808±5nm nm diode, power: 0.20 W, irradiance: 1.97W/cm2 in continuous wave mode was used. LLLT was delivered by applying the laser probe over 8 points per canine tooth (4 buccal, 4 palatal). The laser output was set at 10 seconds per point, continuous mode. This gave 1.72 Joules (J) of energy per point, a total of 13.87J per visit.
Low level laser therapy was applied at commencement of canine retraction, day 0 (T0), day 28 (T1), and day 56 (T2) immediately after spring activation.
Protective goggles were worn, and patients were irradiated individually in an enclosed room as per laser specifications. This occured at an Urband Dental Hospital, Orthodontics Department in an enclosed treatment room.
The sham laser function did not deliver any energy output however would perform identically to the test laser function, therefore, and as the wavelength used was not in the visible spectrum, the operator and patient were blinded.
Any breakages were rectified within 24 hours else the patient was excluded from the study.

Materials:
SPEED brackets (Hanson prescription, Strite Industries, Cambridge, Ontario, Canada)
Nickel titanium (NiTi) (3M Unitek, Monrovia, California, USA)
3t Tri-Tanium Memory wire (American Orthodontics, Sheboygan, WI)
medium super-elastic NiTi closed coil springs (Orthomax, TOMY International Inc., Australia)
Powerarms (0.016 x 0.016-inch SS – Dentarum, Ispringen, Germany)
beta-titanium molybdenum (TMA, 3M Unitek)
Calibrated spring gauge (Dentarum)
Occlusal stops (Transbond Plus Light Cure Band Adhesive; 3M Unitek)
An aluminium gallium arsenide laser (Thor Photomedicine Ltd, Buckinghamshire, UK).
Intervention code [1] 315382 0
Treatment: Devices
Comparator / control treatment
Control group with a sham/placebo LLLT application using a split mouth study design
Control group
Placebo

Outcomes
Primary outcome [1] 321181 0
To investigate the effect of 4-weekly applications of LLLT on the amount (millimeters) of tooth movement when 150-gram distalization forces are applied to maxillary canines as measured on digital study casts using the Orthoanalyzer program
Timepoint [1] 321181 0
Primary timepoint was T3 (12 weeks).
The assessed timepoints were:
At start of intervention (T0),
at 4 weeks post commencement of trial (T1),
at 8 weeks post commencement of trial (T2)
and at 12 weeks post commencement of trial (T3) [primary timepoint].
Secondary outcome [1] 374204 0
Differences in anchorage loss (millimeters) between control and LLLT groups.
Anchorage loss is measured on digital study casts on the Orthoanalyzer program from an occlusal view from the distal of the second premolar to the most mesial point of the third palatal rugae via the mid saggital plane.
Timepoint [1] 374204 0
At start of intervention (T0),
and at 12 weeks post commencement of trial (T3)
Secondary outcome [2] 374205 0
Differences in canine rotation (degrees) between control and LLLT groups.
Canine rotation is measured on digital study casts on the Orthoanalyzer program with reference to the occlusal plane ( set from the most occlusal tip of the second molars to the most incisal tip of the central incisors). On this view, canine rotation was calculated by the angle formed from the line created from the mesial and distal contact points of the maxillary canine to the mid saggital plane.
Timepoint [2] 374205 0
At start of intervention (T0),
and at 12 weeks post commencement of trial (T3)

Eligibility
Key inclusion criteria
Patients requiring extraction of maxillary first premolars and canine retraction with moderate anchorage as part of their orthodontic treatment. These patients required a minimum of 3mm space after initial alignment for canine retraction.
Minimum age
13 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) patients with medical conditions or medications affecting the development or structure of teeth, alveolar bone or rate of tooth movement,
(2) patients with craniofacial anomalies,
(3) patients not in the permanent dentition, or with dental anomalies or missing teeth,
(4) patients with previous dental treatment of the maxillary canines,
(5) patients with previous orthodontic treatment,
(6) patients with a history of trauma, bruxism or parafunction and
(7) patients with a past or present history of periodontal disease.

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)
Allocation concealment took place through an enclosed internal laser switch where the laser and sham settings were set by a person (A.K.P.) with details unknown to the operator (D.M). The switch casing is enclosed so that the switch settings are concealed from the operator.
The internal switch settings of laser and sham were allocated to a letter A or B and details placed in a concealed envelope which was revealed after data analysis.
The laser wavelength (810nm) is not visible to the human eye, therefore the patient, operator and assessor were blinded throughout the study.
Statistical analysis was performed with the assessor blinded to whether sides A and B were either LLLT or control sides.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At the beginning of the retraction period, the right canine tooth from each patient was randomly allocated to a letter A or B using a randomisation software (randomization.com) with a 1:1 allocation ratio.
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
Other
Other design features
Split mouth design (one side received treatment, the other side received the sham treatment)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics would be calculated including means and Standard Deviations (SD) for continuous variables and absolute/relative frequencies for categorical variables. Since the right/left side of a patient’s mouth are correlated, linear regression modelling with robust standard errors will be used to account for clustering and results expressed as unstandardized regression coefficients (ß) and 95% Confidence Intervals (CI).
Initially, crude regression models with experimental group as independent variable and (a) change in space closure overall (T0-T3) or during each month (T0-T1, T1-T2, and T2-T3), (b) change in canine rotation (T0-T3), and (c) change in anchorage loss (T0-T3) would be constructed. Afterwards, patient age, patient sex, mouth side, and baseline (T0) spaces to be closed will be added one at a time as covariates and selected for addition in an adjusted model for a change-in-estimate of the experimental group on the outcome of at least 10%. All analyses will be run in Stata SE 14.0 (StataCorp, College Station, TX)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/06/2017
Date of last participant enrolment
Anticipated
Actual
27/04/2018
Date of last data collection
Anticipated
Actual
12/04/2019
Sample size
Target
22
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14622 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 27646 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 303472 0
Charities/Societies/Foundations
Name [1] 303472 0
Australian Society of Orthodontists Foundation for Research and Education
Country [1] 303472 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Disclipine of Orthodontics
Faculty of Medicine and Health
Sydney Dental Hospital, Level 2 Orthodontics Department
2 Chalmers Street, Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 303530 0
Government body
Name [1] 303530 0
Sydney Local Health District
Address [1] 303530 0
Department Of Orthodontics
Sydney Dental Hospital, Level 2
2 Chalmers Street, Surry Hills
NSW 2010
Country [1] 303530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304002 0
Sydney local area health district, RPAH zone
Ethics committee address [1] 304002 0
Ethics committee country [1] 304002 0
Australia
Date submitted for ethics approval [1] 304002 0
03/11/2015
Approval date [1] 304002 0
18/12/2015
Ethics approval number [1] 304002 0
X14-0200 & HREC/14/RPAH/263

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95518 0
Dr Dipika Mistry
Address 95518 0
The University of Sydney, School of Dentistry
Faculty of Medicine and Health
Sydney Dental Hospital, Level 2 Orthodontics Department
2 Chalmers Street, Surry Hills NSW 2010
Country 95518 0
Australia
Phone 95518 0
+61 2 9351 8314
Fax 95518 0
Email 95518 0
mistry.dipika@gmail.com
Contact person for public queries
Name 95519 0
Alexandra K Papadopoulou
Address 95519 0
The University of Sydney, School of Dentistry
Faculty of Medicine and Health
Sydney Dental Hospital, Level 2 Orthodontics Department
2 Chalmers Street, Surry Hills NSW 2010
Country 95519 0
Australia
Phone 95519 0
+61 2 9351 8314
Fax 95519 0
Email 95519 0
alexandra.papadopoulou@sydney.edu.au
Contact person for scientific queries
Name 95520 0
Alexandra K Papadopoulou
Address 95520 0
The University of Sydney, School of Dentistry
Faculty of Medicine and Health
Sydney Dental Hospital, Level 2 Orthodontics Department
2 Chalmers Street, Surry Hills NSW 2010
Country 95520 0
Australia
Phone 95520 0
+61 2 9351 8314
Fax 95520 0
Email 95520 0
alexandra.papadopoulou@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data of all the measurements performed
When will data be available (start and end dates)?
Currently available. No end date determined.
Available to whom?
Open Access - available on Zenodo
Available for what types of analyses?
Any type of analysis
How or where can data be obtained?
Open Access - on Zenodo website
http://doi.org/10.5281/zenodo.3376382


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4310Ethical approval    Amendment added 378115-(Uploaded-26-08-2019-18-43-58)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.