Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000683336
Ethics application status
Approved
Date submitted
5/05/2017
Date registered
12/05/2017
Date last updated
29/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Do Australian orthodontists’ need a lateral cephalometric radiograph to diagnose malocclusions?
Scientific title
Australian orthodontists’ diagnosis of malocclusions with lateral cephalometric radiographs: double blind, clinical randomised equivalence trial.
Secondary ID [1] 291852 0
None
Universal Trial Number (UTN)
U1111-1193-2387
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Malocclusions 303106 0
Condition category
Condition code
Oral and Gastrointestinal 302566 302566 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised equivalence trial will assess the relevance of the lateral cephalometric radiograph for diagnosis and treatment planning in orthodontics. The orthodontists who are willing to join this study will be randomly allocated into two groups. One control group and one intervention group. Those in the control group will receive a questionnaire consisting of one random orthodontic case, with all diagnostic material including a lateral cephalometric radiograph. Whereas, those in the intervention group will receive a questionnaire consisting of a random orthodontic case, without the lateral cephalometric radiograph. Orthodontists will be required to give their diagnosis and treatment plan for the given case using the provided information, taking approximately 10 minutes of their time.
Intervention code [1] 297961 0
Diagnosis / Prognosis
Comparator / control treatment
The control group consists of orthodontists who receive a questionnaire with a lateral cephalometric radiograph included for their use in diagnosis and treatment planning.
Control group
Active

Outcomes
Primary outcome [1] 301984 0
To determine if there is any change in the diagnosis when orthodontists are presented with a typical orthodontic case, with or without a lateral cephalometric radiograph.
Timepoint [1] 301984 0
Questionnaires will be taken at a single timepoint.
Assessed using a questionnaire of a randomised typical orthodontic case, specifically designed for the study.
Secondary outcome [1] 334443 0
To determine if there is a difference in treatment planning decision-making when orthodontists are presented with a typical orthodontic case, with or without a lateral cephalometric radiograph.
Timepoint [1] 334443 0
Questionnaires will be taken at a single timepoint.
Assessed using a questionnaire of a randomised typical orthodontic case, specifically designed for the study.

Eligibility
Key inclusion criteria
Current AHPRA registered specialist Orthodontists
Minimum age
28 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NA, inclusion criteria is specific.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by means of a third person separate to the research assessors and analysts, who was responsible for the randomisation. The method applied was central randomisation of the list of AHRPRA registered specialist orthodontists by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Convenience sampling will be used to recruit participants. The parameters used to calculate sample size were as per an equivalence trial, as shown below. Interim analyses may be performed during the trial to test the levels of significance. Ideally, these will be performed when 50% and 75% of the data has been collected.

Sample size calculations as per an equivalence trial:
AHPRA Registered Orthodontists - 608 (n)
Type 1 Error - 0.5
Power - 0.8
Expected Proportion - 0.9
Equivalence Difference -0.05
Sample Size - 135 per group, 270 in total (n)

Statistical methods will be used to compare control and intervention groups for primary and secondary outcomes. Methods for additional analyses, such as subgroup analyses and adjusted analyses will also be carried out. The response rate of the surveys will be calculated depending upon the sample size calculation, the surveys received after one reminder and two reminders, and those who did not respond at all. A more detailed description of the statistical methods will be provided in the final report.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2017
Actual
26/05/2017
Date of last participant enrolment
Anticipated
31/07/2017
Actual
3/08/2017
Date of last data collection
Anticipated
31/07/2017
Actual
3/08/2017
Sample size
Target
270
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8872 0
New Zealand
State/province [1] 8872 0

Funding & Sponsors
Funding source category [1] 295664 0
Self funded/Unfunded
Name [1] 295664 0
NA
Country [1] 295664 0
Primary sponsor type
Individual
Name
Carmen Karadeniz
Address
James Cook University
Head of Orthodontics, Faculty of Dentistry
14-88 McGregor Road, Smithfield 4878 QLD
Country
Australia
Secondary sponsor category [1] 294511 0
Individual
Name [1] 294511 0
Neil Meredith
Address [1] 294511 0
James Cook University
Head of School, Faculty of Dentistry
14-88 McGregor Road, Smithfield 4878 QLD
Country [1] 294511 0
Australia
Secondary sponsor category [2] 295284 0
Individual
Name [2] 295284 0
Adrian Esterman
Address [2] 295284 0
James Cook University
Professor - Biostatistics and Population Health, Australian Institute of Tropical Health and Medicine, Cairns
14-88 McGregor Road, Smithfield 4878 QLD
Country [2] 295284 0
Australia
Other collaborator category [1] 279558 0
Individual
Name [1] 279558 0
Sophie Roberts
Address [1] 279558 0
James Cook University
Bachelor of Dental Surgery Student, Faculty of Dentistry
14-88 McGregor Road, Smithfield 4878 QLD
Country [1] 279558 0
Australia
Other collaborator category [2] 279559 0
Individual
Name [2] 279559 0
Scott Currell
Address [2] 279559 0
James Cook University
Bachelor of Dental Surgery Student, Faculty of Dentistry
14-88 McGregor Road, Smithfield 4878 QLD
Country [2] 279559 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296980 0
James Cook University Human Ethics Research Committee
Ethics committee address [1] 296980 0
Research Office, Room 128, Faculty Science & Engineering Building (DB17) , James Cook University, Townsville, Qld, 4811
Ethics committee country [1] 296980 0
Australia
Date submitted for ethics approval [1] 296980 0
14/12/2016
Approval date [1] 296980 0
04/04/2017
Ethics approval number [1] 296980 0
H6837

Summary
Brief summary
Lateral head radiographs are routinely prescribed to every patient who is willing to have braces to correct their abnormal teeth positions (malocclusion). However, the information gathered during a clinical examination of the patient is fundamental to determine the diagnosis of a given malocclusion. The aim of the present investigation is to test the null hypothesis that lateral head radiographs will not alter Australian Orthodontists’ diagnosis and treatment planning decisions.

If the results are consistent with our hypothesis and lateral head radiographs are not a ‘must have’ diagnostic record in orthodontics, we can suggest that lateral head radiographs should not be prescribed routinely to all patients. This would alter the conventional prescription of lateral head radiographs required for orthodontic diagnosis. The omission of the lateral head radiograph from a susceptible age group would limit the amount of ionising radiation exposure.
Trial website
Trial related presentations / publications
Public notes
Informed consent will be attained from each participant prior to commencing the project. Participants will give their consent by ticking the informed consent box on the questionnaire. The questionnaire will be sent out to AHPRA registered orthodontists, and their responses will only be considered in the project if this box has been selected.
The dental records of the patients to be sent to the participating orthodontists are to be de-identified and have had prior consent for use for academic/teaching purposes.
Attachments [1] 1694 1694 0 0
/AnzctrAttachments/372388-Application Summary H6837 Karadeniz.pdf (Ethics approval)
Attachments [2] 1695 1695 0 0
/AnzctrAttachments/372388-Approval Form H6837 Karadeniz.pdf (Ethics approval)
Attachments [3] 1696 1696 0 0
/AnzctrAttachments/372388-PROPOSAL_Project_Lateral Ceph Radiographs in Orthodontics.docx (Protocol)

Contacts
Principal investigator
Name 72610 0
Dr Carmen Karadeniz
Address 72610 0
James Cook University
Faculty of Dentistry
14-88 McGregor Road, Smithfield 4878, QLD
Country 72610 0
Australia
Phone 72610 0
+61 07 4232 1921
Fax 72610 0
Email 72610 0
[email protected]
Contact person for public queries
Name 72611 0
Dr Carmen Karadeniz
Address 72611 0
James Cook University
Faculty of Dentistry
14-88 McGregor Road, Smithfield 4878, QLD
Country 72611 0
Australia
Phone 72611 0
+61 07 4232 1921
Fax 72611 0
Email 72611 0
[email protected]
Contact person for scientific queries
Name 72612 0
Dr Carmen Karadeniz
Address 72612 0
James Cook University
Faculty of Dentistry
14-88 McGregor Road, Smithfield 4878, QLD
Country 72612 0
Australia
Phone 72612 0
+61 07 4232 1921
Fax 72612 0
Email 72612 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
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