Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001211550p
Ethics application status
Submitted, not yet approved
Date submitted
19/09/2024
Date registered
3/10/2024
Date last updated
3/10/2024
Date data sharing statement initially provided
3/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of LightForce vs conventional orthodontic brackets in initial lower arch alignment efficiency and discomfort: a randomised clinical trial
Scientific title
A comparison of LightForce vs conventional preadjusted brackets in initial mandibular alignment efficiency and discomfort: a randomised clinical trial in 11 to 21 year old patients
Secondary ID [1] 313005 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Crowding 335198 0
Condition category
Condition code
Oral and Gastrointestinal 331688 331688 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
The use of LightForce (LightForce Orthodontics, 022 Slot) brackets for the entire duration of fixed orthodontic treatment.
Duration of wear is 24 hours a day.
The brackets will be administered by one single orthodontist in a private practive setting in Queensland.
The brackets will be adjusted and checked every 8-12 weeks, and broken ones replaced, however patients may present earler as an emergnecy bracket reattachment appointment.
Assessing adherence to the intervention is not critical as the brackets are firmly attached to the teeth.
Intervention code [1] 329547 0
Treatment: Devices
Comparator / control treatment
The use of conventional preadjusted (3M Victory and Clarity MBT Prescription, 022 Slot) brackets for the entire duraction of fixed orthodontic treatment.
Duration of wear is 24 hours a day.
The brackets will be administered by one single orthodontist in a private practive setting in Queensland.
The brackets will be adjusted and checked every 8-12 weeks, and broken ones replaced, however patients may present earler as an emergnecy bracket reattachment appointment.
Assessing adherence to the intervention is not critical as the brackets are firmly attached to the teeth.
Control group
Active

Outcomes
Primary outcome [1] 339413 0
Rate of change in lower anterior teeth crowding
Timepoint [1] 339413 0
Baseline and 12 weeks after orthodontic treatment has commenced
Secondary outcome [1] 439827 0
Time taken to reach .016x.022 Nickel-Titanium archwire
Timepoint [1] 439827 0
When fixed orthodontic appliance is inserted and when .016x.022 Nickel-Titanium archwire is installed
Secondary outcome [2] 439828 0
Patient Discomfort
Timepoint [2] 439828 0
6-8 hours, 24 hours and 5 days after orthodontic treatment has commenced
Secondary outcome [3] 440115 0
Total time for fixed orthodontic treatment
Timepoint [3] 440115 0
When fixed orthodontic appliance is inserted and when fixed orthodontic appliance is removed
Secondary outcome [4] 440116 0
Change in dental malocclusion
Timepoint [4] 440116 0
Baseline and when fixed orthodontic appliance is removed
Secondary outcome [5] 440121 0
Total number of broken brackets
Timepoint [5] 440121 0
When fixed orthodontic appliance is removed

Eligibility
Key inclusion criteria
Fixed orthodontic treatment
Permanent dentition
Initial Little's Irregularity Index of 5mm or greater in the mandibular arch
Minimum age
11 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Orthognathic surgery, impacted canines or premolars
Taking medications or have conditions that may affect tooth movement
With cleft palate or other syndromes
With missing lower incisors (either missing or extracted)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2024
Actual
Date of last participant enrolment
Anticipated
13/10/2025
Actual
Date of last data collection
Anticipated
12/04/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317445 0
Charities/Societies/Foundations
Name [1] 317445 0
Australian Society of Orthodontists Foundation for Research and Education
Country [1] 317445 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319735 0
None
Name [1] 319735 0
Address [1] 319735 0
Country [1] 319735 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316161 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 316161 0
Ethics committee country [1] 316161 0
Australia
Date submitted for ethics approval [1] 316161 0
10/09/2024
Approval date [1] 316161 0
Ethics approval number [1] 316161 0

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

Contacts
Principal investigator
Name 136986 0
Dr William Aung
Address 136986 0
UQ School of Dentistry - Oral Health Centre, 288 Herston Road Corner Bramston Terrace and Herston Road Herston QLD 4006
Country 136986 0
Australia
Phone 136986 0
+61 0406941078
Fax 136986 0
Email 136986 0
[email protected]
Contact person for public queries
Name 136987 0
William Aung
Address 136987 0
UQ School of Dentistry - Oral Health Centre, 288 Herston Road Corner Bramston Terrace and Herston Road Herston QLD 4006
Country 136987 0
Australia
Phone 136987 0
+61 0406941078
Fax 136987 0
Email 136987 0
[email protected]
Contact person for scientific queries
Name 136988 0
William Aung
Address 136988 0
UQ School of Dentistry - Oral Health Centre, 288 Herston Road Corner Bramston Terrace and Herston Road Herston QLD 4006
Country 136988 0
Australia
Phone 136988 0
+61 0406941078
Fax 136988 0
Email 136988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Most patients will be minors under age 18


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.