Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000682448
Ethics application status
Approved
Date submitted
19/05/2016
Date registered
25/05/2016
Date last updated
26/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect or LLLT (low level laser therapy) on repair of root resorption undergoing bilateral first pre-molar extraction.
Scientific title
The effect or LLLT (low level laser therapy) on repair of root resorption undergoing bilateral first pre-molar extraction.
Secondary ID [1] 289251 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Root resorption (related to orthodontic treatment) 298827 0
Tooth crowding 298880 0
Condition category
Condition code
Oral and Gastrointestinal 298888 298888 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
Method:
Phase 1: orthodontic tooth movement (Duration 4 weeks)
1) Orthodontic brackets bonded to the upper first permanent molar and first premolar teeth.
2) 150g buccally directed force, applied bilaterally to the first premolars to achieve buccal tipping. 4 weeks of force application:
*Using a 0.017” x 0.025” TMA (Ormco, CA) spring.
*Force magnitude measured to the nearest gram with a strain gauge (Dentaurum, Germany).

Phase 2: Removal of orthodontic force, Initiation of rest period, laser application (intervention) on experimental side, sham laser (no power) on control side. (Duration 6 weeks)

1) Orthodontic force is ceased
2) A fixed retainer constructed of 0.018” stainless steel will be bonded to the teeth to hold them passively in place.
3) During this period, laser will be applied to randomly assigned experimental side whilst the contralateral side serving as a control will receive the ‘sham’ laser.
4) Laser application - Experimental side. (660nm AlGaInP Laser Dental Probe, Thor Photomedicine Ltd, ARTG: 197699).

*6 exposures per session. This comprises 3 points along root of the tooth (crestal, mid root, apex) for each of the buccal and palatal aspects of the tooth.
* Each LLLT exposure is with a wavelength within the visible spectrum (660 nm). (Irradiance of 0.764W/cm-2 for 7 seconds which equals ~ 5.4J/cm-2 per exposure.).
*Laser sessions (once per week) for 6 weeks. This was determined based on convenience to the patient and attempting to be clinically applicable.
*Sham laser application on control side – no energy output (Sham setting on laser unit).

Each laser dose will be 7 seconds. 6 doses will be approximately 42 seconds in total. This compromises the total active time the laser will be used per session.

The approximate time of each laser appointment will be 15 minutes, however, the total active time regarding laser exposure is approximately 42 seconds as mentioned above.

An orthodontic registrar will be administering the laser dosages.

Strategies for compliance would be attendance at laser appointments.

Phase 3: Completion of rest period, extraction of first premolars for micro-ct study (1 visit for the patient).
4) Bilateral extraction of first premolars ~6 weeks after commencement of rest/healing phase.
*Analysis of teeth at Sydney Dental Hospital using a Micro-CT scanner.
*Amount of root resorption repair with and without laser to be compared
Intervention code [1] 294795 0
Treatment: Devices
Comparator / control treatment
Split mouth design.
Comparator will be the same tooth on the contralateral side which will receive no intervention (delivered via a sham setting on the laser which will deliver no dose to the tooth applied).
Control group
Placebo

Outcomes
Primary outcome [1] 298357 0
Level of root resorption assessed qualitatively and quantitatively using micro-CT evaluation of the extracted teeth
Timepoint [1] 298357 0
6 weeks post commencement of laser therapy
Secondary outcome [1] 323929 0
None
Timepoint [1] 323929 0
None

Eligibility
Key inclusion criteria
*Need for bilateral maxillary first premolar extractions (necessitating moderate anchorage requirements) and fixed appliance treatment;
*Permanent Dentition;
*Apexification (root formation) completed;
*Similar degree of minimal crowding on each side of the maxillary arch;
Minimum age
10 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Treatment plan that does not require extraction of upper first premolars
* previous orthodontic or orthopaedic treatment;
*craniofacial anomaly present;
*previous reported or observed dental treatment of the maxillary canines;
*history of trauma, bruxism or parafunction;
*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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2016
Actual
9/01/2017
Date of last participant enrolment
Anticipated
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] 5816 0
Sydney Dental Hospital - Surry Hills

Funding & Sponsors
Funding source category [1] 293629 0
University
Name [1] 293629 0
Sydney University
Country [1] 293629 0
Australia
Primary sponsor type
University
Name
Sydney University
Address
Orthodontic department,
Level 2, Sydney Dental Hospital,
2 Chalmers St,
Surry Hills,
NSW,
2010.
Country
Australia
Secondary sponsor category [1] 292462 0
Other
Name [1] 292462 0
Australian Orthodontic Society
Address [1] 292462 0
204 / 133 Alexander St Crows Nest NSW 2065
Country [1] 292462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295068 0
NSW Health Human Research Ethics Committees (HRECs)
Ethics committee address [1] 295068 0
Ethics committee country [1] 295068 0
Australia
Date submitted for ethics approval [1] 295068 0
23/05/2016
Approval date [1] 295068 0
22/06/2016
Ethics approval number [1] 295068 0

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

Contacts
Principal investigator
Name 65978 0
Dr Chun Min Ang-Khaw
Address 65978 0
University of Sydney,
Orthodontic Department,
Level 2,
2 Chalmers St,
Surry Hills,
NSW,
2010.
Country 65978 0
Australia
Phone 65978 0
+61 2 9351 8314
Fax 65978 0
Email 65978 0
[email protected]
Contact person for public queries
Name 65979 0
Chun Ang-Khaw
Address 65979 0
University of Sydney,
Orthodontic Department,
Level 2,
2 Chalmers St,
Surry Hills,
NSW,
2010.
Country 65979 0
Australia
Phone 65979 0
+61 2 9351 8314
Fax 65979 0
Email 65979 0
[email protected]
Contact person for scientific queries
Name 65980 0
Chun Ang-Khaw
Address 65980 0
University of Sydney,
Orthodontic Department,
Level 2,
2 Chalmers St,
Surry Hills,
NSW,
2010.
Country 65980 0
Australia
Phone 65980 0
+61 2 9351 8314
Fax 65980 0
Email 65980 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.