Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000511336p
Ethics application status
Submitted, not yet approved
Date submitted
4/04/2017
Date registered
7/04/2017
Date last updated
8/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of a clear dental aligner system for orthodontic treatment
Scientific title
An open label investigation of a Clear Aligner System for orthodontic treatment of malocclusion.
Secondary ID [1] 291589 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
OKCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental malocclusion 302703 0
Condition category
Condition code
Oral and Gastrointestinal 302221 302221 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
Use of a Clear Aligner System to treat orthodontic malocclusion. The clear aligner system is an alternative to braces and allows for better oral hygiene as the aligner can be removed to allow for brushing of teeth and rinsing with mouthwash. After a 3D scan and x-rays of the teeth, a virtual model of the desired treatment outcome is created and a series of aligners is designed to achieve that outcome. Each aligner is reused on a daily basis, being removed for a maximum of 2 hours each day while consuming liquids other than water, while eating and to brush, floss and rinse to maintain good oral hygiene. The aligner is also worn at night. After use, the aligner should be cleaned by rinsing in accordance with the participant instructions for use and care of the aligner.
The participant is instructed by their orthodontist to change aligners every 1-2 weeks at home. These devices are custom-made for each participant and may be used in conjunction with accessories such as buttons and elastics. Modifications to the aligner design and treatment plan can be done as deemed necessary by the treating orthodontist. This information is captured in the CRFs and patient compliance is partly indicated by the reconciliation of the returned, used, aligners.
Treatment is projected to last approximately 12 months. Participants will visit their orthodontist quarterly while on treatment and each visit is expected to be approximately 30-45 mins in duration including 3D scans, and safety reporting. The initial and final treatment visits may take up to 30 minutes longer to accommodate x-rays, extra-oral photographs and questionnaire..
Intervention code [1] 297657 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301631 0
Determination/Objective proof for the safety of the device and documentation of case reports to fulfil FDA clinical evidence requirement.
Safety will be assessed at the completion of study by an analysis of the results presented in x-rays (performed at baseline and the final visit), photographs (taken throughout study at scheduled visits) and scans of the oral cavity (taken throughout study at scheduled visits). The occurrence of adverse events that are reported by the investigator, and information gathered in the participant questionnaire.
Timepoint [1] 301631 0
approx. 12 months
Secondary outcome [1] 333352 0
Determination of effectiveness of the device over a 52 aligner treatment period (approx. 12 months) compared to the predicted outcome. Overall accuracy will be measured by superimposition of 3d model of the predicted outcome for the patient against the actual outcome. This is a composite secondary outcome. The change to the secondary objective and endpoint was made prior to any participants being enrolled.
Timepoint [1] 333352 0
approx. 12 months

Eligibility
Key inclusion criteria
18 to 60 years of age
Meets predefined criteria for type and extent of dental malocclusion treatment
At least one of the following treatments:
*Intrusion, extrusion
*Rotation
*Expansion
*Posterior space closure (either due to tooth extraction or pre-existing spaces) through Mesial/distal translation
*Tip and torque correction
Provides written informed consent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active periodontal disease
*History of alcohol or drug abuse
*Allergy to any of the materials used in the device
*Diagnosed hereditary angioedema (HAE)
*Pregnant or intending to become pregnant during the trial period
*Inability to comply with device care instructions
*Inability to comply with device use instructions
*Inability to comply with treatment visit schedule
*Inability to comply with any other aspect of the protocol e.g. testing
*Determined by the investigator to be unsuitable for participation in the trial

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A minimum of 30 subjects is required to complete the trial for a power of 80% to detect a mean percent accuracy of 56% with a standard deviation of 33% (Kravitz et al), a two-sided test, alpha=0.05 for five types of movement with a minimum of five subjects within each type of movement. The anticipated drop-out rate is approximately twenty percent, based on all types of orthodontic treatment. Hence up to 50 subjects will be recruited and subjects will not be replaced.

The study aims to gather information on safety and effectiveness of the aligner when used to treat malocclusions. Efficacy will be measured by the amount of movement undertaken compared with that predicted.
Each tooth will be identified by subject, type of tooth (central incisor, lateral incisor, canine, first pre-molar, second pre-molar and first molar) and type of movement required. Teeth may require more than one type of movement.
The amount of movement predicted for rotation, tip, torque, mesio-distal movement, lingual buccal movement, intrusion and/or extrusion for each tooth that will be treated with the aligner for each subject at baseline and an updated prediction at 6 months. The amount of each type of movement achieved at 6 months will be compared with that predicted at baseline and the amount at 12 months compared with the updated prediction at 6 months using an estimate of accuracy determined as:
Percentage of accuracy = 100% - [(|predicted-achieved|/ |predicted|) x 100%]Percentage of accuracy for each type of movement will be summarized descriptively for each type of tooth and overall at each available time point. The percentage of accuracy for each type of tooth will also be summarized by each type of movement and overall. Summary statistics will include the number of observations, mean, standard deviation, minimum and maximum. All data will be listed by subject number. All formal data analysis will be undertaken after the 12 month timepoint. No interim analysis is planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
Date of last participant enrolment
Anticipated
31/08/2018
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 296077 0
Commercial sector/Industry
Name [1] 296077 0
Ormco Corporation
Country [1] 296077 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mobius Medical Pty Ltd
Address
Suite 1002, 23 Hunters Street Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 294972 0
None
Name [1] 294972 0
Address [1] 294972 0
Country [1] 294972 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297335 0
Bellberry Limited
Ethics committee address [1] 297335 0
Ethics committee country [1] 297335 0
Australia
Date submitted for ethics approval [1] 297335 0
31/03/2018
Approval date [1] 297335 0
Ethics approval number [1] 297335 0

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

Contacts
Principal investigator
Name 73742 0
Dr Ashley Smith
Address 73742 0
Toowoomba Orthodontists
301 Margaret Street
Toowoomba QLD 4350
Country 73742 0
Australia
Phone 73742 0
+61 401 963 403
Fax 73742 0
Email 73742 0
[email protected]
Contact person for public queries
Name 73743 0
Suzanne Williams
Address 73743 0
Mobius Medical Pty Ltd
Level 10, 23 Hunter Street
Sydney NSW 2000
Country 73743 0
Australia
Phone 73743 0
+61 2 83175460
Fax 73743 0
Email 73743 0
[email protected]
Contact person for scientific queries
Name 73744 0
Ashley Smith
Address 73744 0
Toowoomba Orthodontists
301 Margaret Street
Toowoomba QLD 4350
Country 73744 0
Australia
Phone 73744 0
+61 401 963 403
Fax 73744 0
Email 73744 0
ashley@twmbaortho

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.