Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000402741
Ethics application status
Approved
Date submitted
7/10/2021
Date registered
9/03/2022
Date last updated
9/03/2022
Date data sharing statement initially provided
9/03/2022
Date results information initially provided
9/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparative assessment of orthodontic treatment outcomes between clear aligners and fixed orthodontic appliances in moderate malocclusions: a prospective study
Scientific title
A comparative assessment of orthodontic treatment outcomes between clear aligners and fixed orthodontic appliances in moderate malocclusions: a prospective study
Secondary ID [1] 305482 0
Align Technology CSP-700011-00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental malocclusion 323865 0
Condition category
Condition code
Oral and Gastrointestinal 321381 321381 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
Participants are recruited from two private orthodontic practices in Melbourne, Australia. Each patient will be treated with clear aligners or fixed appliances.
All participants are treated by experienced specialist orthodontists. The clear aligner treatment (CAT) group will use Invisalign® aligners (Align® Technology Inc., San Jose, CA, USA). Invisalign® subjects’ treatment will include the most up-to-date features of the system including SmartTrackTM, SmartStagingTM and SmartForceTM including BiteRampsTM, PrecisionCutsTM and Power RidgesTM.
The Invisalign appliance is fitted by a specialist orthodontist at the start of treatment. Patients are advised to wear their aligners for approximately 22 hours daily. Aligners are to be removed for eating, drinking and brushing teeth. Each aligner will be worn for one week, and then replaced by the participant by the next in the series until the final one in the series was achieved. Participants are reviewed by the specialist orthodontist every 6-12 weeks with a minimum of 15 minute appointment, or as required. Compliance is measured by self-reporting.
Total duration of treatment is the time required to correct the dental malocclusion.
Intermaxillary elastics will be used as necessary.
Potential participants who met the eligibility criteria were invited to participate in the study with appliance selection decision was made by the participant in collaboration with their treating orthodontist.
Intervention code [1] 321884 0
Treatment: Devices
Comparator / control treatment
The control group will be treated with conventional fixed appliances (braces) by a specialist orthodontist. The fixed appliance (FA) group will use Empower® 0.022” brackets (American Orthodontics; Sheboygan, WI, USA) from the 2nd molar to 2nd molar, unless specifically contraindicated. The FA are placed in a single one-hour appointment. The archwire material and sequence will chosen by the clinical situation and clinician’s choice.
Participants are reviewed by the specialist orthodontist every 6-8 weeks with a minimum of 15 minute appointment, or as required.
The total duration of treatment is the time required to correct the dental malocclusion.
Intermaxillary elastics will be used as necessary. Compliance is measured by self-reporting.
Control group
Active

Outcomes
Primary outcome [1] 329155 0
The primary outcome is to assess the post-treatment outcome with the evaluation of 3D printed models for the American Board of Orthodontics Cast Radiographic evaluation (ABO CRE) outcome measure.
Timepoint [1] 329155 0
Specific timepoints measured are day of insertion, 8 weeks, 16 weeks, 6 months, every 6 months after the initial 6 months and at the end of treatment (primary timepoint).
Secondary outcome [1] 401665 0
The secondary outcome is to compare the total treatment duration from medical records data
Timepoint [1] 401665 0
Specific timepoint measured at the end of treatment.
Secondary outcome [2] 404638 0
Total number of appointments from medical records data
Timepoint [2] 404638 0
Specific timepoint measured at the end of treatment.
Secondary outcome [3] 404639 0
Total number of emergency appointments from medical records data
Timepoint [3] 404639 0
Specific timepoint measured at the end of treatment.
Secondary outcome [4] 404640 0
Total number of missed appointments from medical records data
Timepoint [4] 404640 0
Specific timepoint measured at the end of treatment.
Secondary outcome [5] 404641 0
Patient satisfaction was assessed for the two groups with a modified Child Perception Questionnaire (CPQ).
Timepoint [5] 404641 0
Specific timepoints measured are day of insertion, 8 weeks, 16 weeks, 6 months, every 6 months after the initial 6 months and at the end of treatment.

Eligibility
Key inclusion criteria
Inclusion criteria:
• Subjects with moderate malocclusion with 5mm of crowding in the mandibular or maxillary arch
• Participant and/or parent signed consent form
• Aged 12 years and older
• Permanent dentition (except second or third molars)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
• Active periodontal disease
• Active dental caries
• Known allergies to latex and / or plastic
• Antero-posterior correction of greater than 4 mm
• Subjects requiring molar and premolar extractions
• Subjects requiring orthognathic surgery, combination of FA and CAT, use of
accelerated tooth movement devices e.g., AcceleDent® (OrthoAccel® Technologies Inc., Houston, TX, USA) or the use of extra-oral anchorage e.g., headgear
• Any condition making the subject unsuitable for orthodontic treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power and sample size calculations were completed. For 90% power and 5% significance, and assuming that the standard deviation will be approximately 25% (with the acceptable difference of 15%), the overall sample size is 60 participants. This includes consideration for the matching of Peer Assessment Rating (PAR) scores and loss to follow up.
All analyses to be conducted using R for Windows (version 4.1; R Development Core Team; Vienna, Austria), with statistical significance set at the 5% level.
Descriptive statistics will be calculated for the subject’s demographic and pre-treatment variables including ICON and LII. The ABO CRE scores will be assessed for normally distributed, and compared with Welch’s two- sample t-test. A linear regression model will be used to assess the effect of pre-treatment weighted ICON scores on the post-treatment ABO CRE total score.
The data for the secondary outcomes regarding treatment efficiency and patient satisfaction will be assessed for normal distribution. Potentially, non-parametric tests (Mann-Whitney U test) will be used to assess patient satisfaction, treatment efficiency including treatment duration, number of emergency, missed and total number of appointments between the groups (CAT adult, CAT adolescent and FA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/10/2017
Date of last participant enrolment
Anticipated
Actual
31/12/2018
Date of last data collection
Anticipated
Actual
30/06/2021
Sample size
Target
60
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 35460 0
3000 - Melbourne
Recruitment postcode(s) [2] 35461 0
3106 - Templestowe
Recruitment postcode(s) [3] 35459 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 309839 0
Commercial sector/Industry
Name [1] 309839 0
Align® Technology Incorporated
Country [1] 309839 0
United States of America
Funding source category [2] 309840 0
University
Name [2] 309840 0
University of Melbourne
Country [2] 309840 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Foundation for Orthodontic Research and Education
Address
ASO Secretariat
P.O. Box 543
CROWS NEST NSW 1585
Country
Australia
Secondary sponsor category [1] 310875 0
None
Name [1] 310875 0
Address [1] 310875 0
Country [1] 310875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309580 0
Medicine and Dentistry Human Ethics Sub-Committee of the University of Melbourne
Ethics committee address [1] 309580 0
University of Melbourne
720 Swanston St
Carlton VIC 3053
Ethics committee country [1] 309580 0
Australia
Date submitted for ethics approval [1] 309580 0
03/04/2017
Approval date [1] 309580 0
04/10/2017
Ethics approval number [1] 309580 0
Ethics ID: 1749569.1

Summary
Brief summary
There are many types of orthodontic appliances with the most common fixed appliance consists of brackets bonded onto the enamel of the teeth and wires that provide the force for tooth movement. The more recent method is with a series of customized clear appliances, called "aligners". The purpose of the study is to compare the outcomes Invisalign® System to the fixed orthodontic appliance; and especially for subjects who have moderate malocclusion (greater than 5mm of crowding in either the maxilla or the mandible). The secondary outcome measures are treatment efficiency and patient satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114658 0
A/Prof Paul Schneider
Address 114658 0
University of Melbourne
School of Dentistry, Orthodontic Department
720 Swanston Street
Carlton
VIC 3053
Country 114658 0
Australia
Phone 114658 0
+61 3 9341 1500
Fax 114658 0
Email 114658 0
pmschn@unimelb.edu.au
Contact person for public queries
Name 114659 0
Dr Adam Wallace
Address 114659 0
University of Melbourne
School of Dentistry, Orthodontic Department
720 Swanston Street
Carlton
VIC 3053
Country 114659 0
Australia
Phone 114659 0
+61 3 9341 1500
Fax 114659 0
Email 114659 0
alwallace@student.unimelb.edu.au
Contact person for scientific queries
Name 114660 0
Dr Adam Wallace
Address 114660 0
University of Melbourne
School of Dentistry, Orthodontic Department
720 Swanston Street
Carlton
VIC 3053
Country 114660 0
Australia
Phone 114660 0
+61 3 9341 1500
Fax 114660 0
Email 114660 0
alwallace@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.