Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000742572
Ethics application status
Approved
Date submitted
2/05/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of orthodontic treatment of a small lower jaw in adolescents using an Invisible bite advancement device (IBAD) study
Scientific title
Evaluation of efficacy of an invisible bite advancement device (IBAD), a removable functional appliance, and a rigid fixed functional appliance for the treatment of Class II malocclusion in adolescents: A single-centre randomized controlled trial
Secondary ID [1] 312067 0
Protocol no. X24-0022 & 2024/ETH00103
Universal Trial Number (UTN)
Trial acronym
IBAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental health 333690 0
overjet correction 333691 0
overbite correction 333762 0
Small lower jaw correction 333763 0
Condition category
Condition code
Oral and Gastrointestinal 330369 330369 0 0
Normal oral and gastrointestinal development and function
Oral and Gastrointestinal 330371 330371 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 present investigation aims to evaluate the effects of clear appliance Class II corrector and compare it with the most used functional appliances such as the Herbst® appliance and twin block.
Group 1 : Invisible bite advancement device (IBAD) (Smartee ™ clear appliance)
Group 2 : Twin Block Appliance
Group 3 : Herbst appliance

Collection of records: the following records will be collected twice (at 2 weeks post-randomization), and at the end of the functional treatment phase (equal to or more than 9 months).
a) Intra- and extra-oral photographs
b) Dental impressions (moulds)
c) CBCT radiograph image
d) 3D image face scanning
Patient referrals will be accessed via the Patient Demand & Waitlist Unit at Sydney Dental Hospital (SDH). Further, the participants who satisfy the selection criteria will be contacted via letters to discuss potential participation. They will be provided with additional information and their interest in participation confirmed when they attend a research eligibility screening appointment. All the interventions which participants will undergo in the study are the standard of orthodontic treatment care in the Orthodontics Department of The Sydney Dental Hospital, Sydney Local Health District (SLHD), NSW. There are no additional procedures which will be carried out solely for research purposes.
Physical examination: All participants will be assessed for Edward H. Angle’s definition for permanent first molar inter-arch relationship, canine relationship, and overjet and overbite. This assessment is a part of routine orthodontic examination carried out for the orthodontic diagnosis, which also aids in treatment planning. 30 minutes is the duration of procedure and will be carried out by participating patient's treating clinician.
Clinical photographs: Both intra-oral photographs and extraoral photographs are taken at baseline (before treatment) and repeated at every appointment. This is also a routine record-keeping method that not only allows visualization of treatment planning but also, enables the clinician to monitor subsequent changes after orthodontic therapy. 30 minutes is the duration of procedure and will be carried out by participating patients treating clinician.
Dental impressions (moulds) and bite-registration: The procedure involves making upper and lower teeth moulds with alginate impression material and recording of bite with dental wax. This procedure is routinely done for functional appliance fabrication. 30 minutes is the duration of procedure and will be carried out by participating patients treating clinician.

3D image face scanning: A non-invasive three-dimensional image capturing modality (Bellus3D ARC7 system). This procedure is carried out in 3D for facial scanning in orthodontics for diagnosis and treatment planning. 30 minutes is the duration of procedure and will be carried out by participating patients treating clinician.

Cone-beam computed tomography (CBCT) radiograph image: A low-dose CBCT image will be taken twice – Image 1 will be captured at pre-treatment stage, and Image 2 will be captured at the end of post-functional phase of orthodontic treatment (at or more than 9 months from pre-treatment stage). A low dose CBCT image scans are performed for orthodontic purposes using a large FoV with reduced parameters (400 µm, 2 to 4 mA and low dose protocols). The parameters mentioned are not only acceptable for visualization of large anatomical structures. (Baumann, Bornstein et al. 2022) but also, are very low in dosage which is comparable to the combined imaging dosage of orthopantomography, lateral cephalogram, and two bite-wing radiographs. Values of 4 mA seem to be a sufficient exposure parameter to depict the most relevant anatomical structures of the jaws with acceptable image quality. (Baumann, Bornstein et al. 2022, Ihlis, Kadesjö et al. 2022, Lynds, Kadesjö et al. 2022). These recommendations are according (Ludlow, Timothy et al. 2015) to the ALARA (as low as reasonably achievable) principle and has been modified to the ALADA or ALADAIP principle, which means ‘as low as diagnostically acceptable being indication-orientated and patient-specific’. (Ludlow, Timothy et al. 2015, Oenning, Jacobs et al. 2018). 30 minutes is the duration of procedure and will be carried out by an Expert Radiographer at the Department of Oral Medicine and Radiology of Sydney Dental Hospital.

Patient compliance monitoring: A Microsensor TheraMon® (MC Technology GmbH, Hargelsberg, Austria) (Figure 5) will be used for objective verification of patients’ compliance. The microsensor is widely used; in orthodontics to monitor children’s adherence to orthodontic treatment, in sleep medicine to monitor special dental sleep appliances to treat patients suffering from obstructive sleep apnea, and in ophthalmology to record temperature values with sufficient precision ensuring reliable wear time recording. The microsensor will allow for a reliable assessment of the effectiveness of treatment with removable appliances used in this study, such as twin block and the invisible bite advancement device (IBAD). This procedure is not routinely done, however, literature suggests that a micorsensors, such as, Theramon®, can be used qualitatively assess patient’s compliance while wearing removable appliances and have shown to be reliable predictors of good patient cooperation. It consists of a (a) polyurethane-coated sensors measuring 12x 8x 4.2 mm that read and record temperature every 15 min to an accuracy of 0.1 C; (b) a docking station that reads the data stored in the sensors; and (c) a software that not only enables an analysis, visualization, and interpretation of data, but also, identifies attempts of tampering/cheating by patients.
Group 1: Invisible bite advancement device (IBAD) (Smartee ™ clear appliance)
The Invisible bite advancement device (IBAD) (Smartee ™ clear appliance) is a functional appliance that is used to push the bottom teeth and jaw forward to align it with the upper jaw. Also, the appliance will simultaneously correct the crowded teeth. The clear appliance will have a series of aligner-trays which the patient needs to change to a new tray every six-weeks. The expected wear duration of the appliance is 22-hours a day. The appliance will be worn after 6 weeks of enrolment for a period of a minimum of 9 months.
Intervention code [1] 328510 0
Treatment: Devices
Comparator / control treatment
Active control groups.
Group 2 : Twin Block Appliance
Group 3 : Herbst appliance
Twin-block appliance ; The twin block appliance is a functional appliance that is used to push the bottom teeth and jaw forward in order to align it with the upper jaw. It is called a “twin block” appliance because there are two parts to the appliance - the upper part and the lower part made of acrylic plates. The twin block appliance is custom made in the Sdyney Dental Hospital’s technical lab. The expected wear duration of this appliance is 22 hours a day
Herbst appliance: Herbst is an orthodontic appliance with attachments and bands to apply force to various parts of the mouth to enable the movement of teeth or the jaw for bite correction. The appliance uses a combination of two rigid springs connected to molar bands. The appliance is assembled and further refined (customised) in the Sydney Dental Hospital using the above-mentioned springs and molar bands. The appliance stays on the teeth 24 hours a day as it is fixed and cannot be removed by the patient.
In this study, Both twin block (removable) and Herbst appliance (fixed) will serve as reference comparators. All appliances will be worn after 6 weeks of enrolment for a period of a minimum of 9 months.

Control group
Active

Outcomes
Primary outcome [1] 338138 0
Dento-skeletal effects
Timepoint [1] 338138 0
Baseline: at 2 weeks post-randomization, and the end of the functional treatment phase ( equal to or more than 9 months)
Secondary outcome [1] 434658 0
User experience with the appliance using a patient questionnaire. The patient questionnaire is specifically designed for this study which will elicit patient experience with the appliance regarding appliance agreeability, and difficulty (appliance wearing, speech, pain, and so on).
Timepoint [1] 434658 0
At the end of the functional treatment phase ( equal to 9 months)

Eligibility
Key inclusion criteria
1. Sex: Male, female
2. Age range: Active pubertal growth evaluated by cervical vertebral maturation stages (CVMS). CVMS up to 3-4
3. Angle’s Class II division 1 malocclusion
4. ANB angle, equal to or more than 3.5° (The ANB angle measures the relative anteroposterior position between the maxilla and mandible. In normal individuals, the ANB angle is 2° ± 2°)
5. Overjet, equal to or more than 5 mm. The overjet is the extent of horizontal (anterioposterior) overlap of the maxillary central incisors over the mandibular central incisors (normal amount of overlap is between 2 and 4mm)
6. Mild-moderate dental crowding (1-4 mm, 4-7 mm respectively including the curve of Spee
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Syndromic individuals (including cleft lip and palate)
2. Crossbite, severe crowding, hypodontia.
3. Temporomandibular joint disorder signs and symptoms
4. Previous Orthodontic treatment

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 (i.e. computerised 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
The sample size is derived from literature considering a dropout rate of 30%, we may need to recruit up to 33 (23/0.7) patients for each group. A formal non-inferiority design in the statistical hypothesis section:

The null hypothesis is that the primary endpoint for the new treatment (Smartee ™ clear appliance) is worse than that of the current standard treatment (Twin-block and Herbst appliance) in skeletal class II growing patients.

The alternative hypothesis the new treatment (Smartee ™ clear appliance) is non-inferior to the standard treatments (Twin-block and Herbst appliance).

We aim to reject the null hypothesis and prove the alternative hypothesis. The major variables that will be compared are overjet and overbite reduction (numerical), ANB angle (numerical), amount of teeth correction (numerical).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
99
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26510 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 42549 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 316426 0
Commercial sector/Industry
Name [1] 316426 0
Zhejiang Yinchili Medical Technology Co., Ltd
Country [1] 316426 0
China
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318598 0
None
Name [1] 318598 0
Address [1] 318598 0
Country [1] 318598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315220 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315220 0
Ethics committee country [1] 315220 0
Australia
Date submitted for ethics approval [1] 315220 0
06/02/2024
Approval date [1] 315220 0
15/05/2024
Ethics approval number [1] 315220 0

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

Contacts
Principal investigator
Name 134026 0
Dr Narayan Gandedkar
Address 134026 0
Faculty of Dentistry / Orthodontic Department Sydney Dental Hospital Level 2, 2 Chalmers Street Surry Hills NSW 2010
Country 134026 0
Australia
Phone 134026 0
+61929318321
Fax 134026 0
Email 134026 0
[email protected]
Contact person for public queries
Name 134027 0
Narayan Gandedkar
Address 134027 0
Faculty of Dentistry / Orthodontic Department Sydney Dental Hospital Level 2, 2 Chalmers Street Surry Hills NSW 2010
Country 134027 0
Australia
Phone 134027 0
+61929318321
Fax 134027 0
Email 134027 0
[email protected]
Contact person for scientific queries
Name 134028 0
Narayan Gandedkar
Address 134028 0
Faculty of Dentistry / Orthodontic Department Sydney Dental Hospital Level 2, 2 Chalmers Street Surry Hills NSW 2010 T
Country 134028 0
Australia
Phone 134028 0
+61477100977
Fax 134028 0
Email 134028 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


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.