Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000194460
Ethics application status
Approved
Date submitted
20/08/2024
Date registered
19/02/2025
Date last updated
19/02/2025
Date data sharing statement initially provided
19/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The clinical effects of the use of mechanical vibration device in conjunction with orthopaedic appliance in correction of mandibular retrusion
Scientific title
The skeletal, dental and soft tissue effects of mechanical vibration on Class II orthopaedic appliance therapy in children aged 10 to 18 years at different stages of skeletal maturity
Secondary ID [1] 312789 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Class II Malocclusion 334850 0
Condition category
Condition code
Oral and Gastrointestinal 331400 331400 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
60 subjects will be recruited for this study who will be randomly allocated, by an independent person, into 4 groups (two positive control groups and two experimental groups). The experimental groups are as follow:

Group Vib-FA-Y: Patients at Cervical Vertebral Maturation of CS 3 and 4 will be treated with functional appliance with vibration device.

Group Vib-FA-M: Patients at Cervical Vertebral Maturation of CS 5 will be treated with functional appliance with vibration device.

All experimental subjects will be treated with a fixed functional appliance to minimise compliance issues. The functional appliance, composed of metal capping on the upper and lower first molars, is cemented onto the teeth. The lower jaw is postured forward by the telescopic arms that are attached to the metal cappings. The upper component of fixed functional appliance also included a palatal expander which is designed to widen the upper jaw. The functional appliance will be used for 9-12 months.

The subjects in the experiment groups will also use the VPro5 C-shaped vibration device (Propel Orthodontics, Milpitas, USA) for 5 minutes a day. This vibration device operates at a frequency of 120 Hz and a magnitude of 50 grams. It is designed to use intra-orally by inserting the C-shape intra-oral attachment between the upper and lower teeth. Patients are instructed to bite on the attachment and the mechanical vibration will be delivered when the patients turn the devices on. The device will turn itself off after 5 minutes.

No other fixed appliance, e.g. braces, will be provided during the functional appliance therapy. All clinical procedures and data analyses will be carried out by principal researcher who has at least 15 years of clinical orthodontic experience.

The following outlines the face-to face appointment visits and clinical procedures of this research:
Visit 1. Standard orthodontic records i.e. photographs, radiographs (cone beam computer tomography) and moulds of the upper and lower teeth will be taken.
Visit 2. 4 to 8 small separating elastics will be placed between the back teeth to create spaces so to allow the metal capping be placed in the following visits.
Visit 3. One week later, the metal cappings will be trialled for the right size and moulds of the upper and lower teeth will be taken. A wax bite which records the ideal lower jaw position will be taken. The metal cappings are then removed and the separating elastics will be replaced.
Visit 4. Two weeks later, the metal cappings with the expander will be cemented to the teeth. The telescopic arms will be attached to the metal cappings using an allen key. This may vary with individual. The subject will be instructed on the use of the mechanical vibration device. This device needs to be used for 5 minutes a day throughout the whole treatment period.
Visit 5. Six weeks later, review appointment and adjustment of the appliance may be done accordingly. At the review appointment, overjet, canine and molar relationships and patient soft tissue profile will be assessed. The patients will be instructed to perform the expansion using an expansion key once a day for 2-3 weeks depending on the amount of expansion needed.
Visit 6-11. Review appointments 6 weekly. The appliance will be checked at each review appointment. At the review appointment, overjet, canine and molar relationships and patient soft tissue profile will be assessed.
Visit 12+. The duration of the functional appliance therapy is 9-12 months depending on the obtainment of ideal canine and molar relationships and soft tissue profile. At the end of this phase of treatment, the function al appliance will be removed and the standard records will be taken i.e. photographs, radiographs (cone beam computer tomography) and moulds of the upper and lower teeth. The research procedures will be finished at this point.
Intervention code [1] 329315 0
Treatment: Devices
Comparator / control treatment
60 subjects will be recruited for this study who will be randomly allocated, by an independent person, into 4 groups (two positive control groups and two experimental groups). The positive control groups are as follow:

Group FA-Y: Patients at Cervical Vertebral Maturation of CS 3 and 4 will be treated with functional appliance only.

Group FA-M: Patients at Cervical Vertebral Maturation of CS 5 will be treated with functional appliance only.

All experimental subjects will be treated with a fixed functional appliance to minimise compliance issues. The functional appliance, composed of metal capping on the upper and lower first molars, is cemented onto the teeth. The lower jaw is postured forward by the telescopic arms that are attached to the metal cappings. The upper component of fixed functional appliance also included a palatal expander which is designed to widen the upper jaw. The functional appliance will be used for 9-12 months.

No other fixed appliance, e.g. braces, will be provided during the functional appliance therapy. All clinical procedures and data analyses will be carried out by principal researcher who has at least 15 years of clinical orthodontic experience.

The following outlines the face-to face appointment visits and clinical procedures of this research:
Visit 1. Standard orthodontic records i.e. photographs, radiographs (cone beam computer tomography) and moulds of the upper and lower teeth will be taken.
Visit 2. 4 to 8 small separating elastics will be placed between the back teeth to create spaces so to allow the metal capping be placed in the following visits.
Visit 3. One week later, the metal cappings will be trialled for the right size and moulds of the upper and lower teeth will be taken. A wax bite which records the ideal lower jaw position will be taken. The metal cappings are then removed and the separating elastics will be replaced.
Visit 4. Two weeks later, the metal cappings with the expander will be cemented to the teeth. The telescopic arms will be attached to the metal cappings using an allen key. This may vary with individual. The subject will be instructed on the use of the mechanical vibration device. This device needs to be used for 5 minutes a day throughout the whole treatment period.
Visit 5. Six weeks later, review appointment and adjustment of the appliance may be done accordingly. At the review appointment, overjet, canine and molar relationships and patient soft tissue profile will be assessed. The patients will be instructed to perform the expansion using an expansion key once a day for 2-3 weeks depending on the amount of expansion needed.
Visit 6-11. Review appointments 6 weekly. The appliance will be checked at each review appointment. At the review appointment, overjet, canine and molar relationships and patient soft tissue profile will be assessed.
Visit 12+. The duration of the functional appliance therapy is 9-12 months depending on the obtainment of ideal canine and molar relationships and soft tissue profile. At the end of this phase of treatment, the function al appliance will be removed and the standard records will be taken i.e. photographs, radiographs (cone beam computer tomography) and moulds of the upper and lower teeth. The research procedures will be finished at this point.
Control group
Active

Outcomes
Primary outcome [1] 339149 0
Dental effects of Class II orthopaedic appliance under influence of mechanical vibration
Timepoint [1] 339149 0
Baseline and end of orthopaedic treatment
Primary outcome [2] 339150 0
Soft tissue changes following Class II orthopaedic treatment under the influence of vibration device
Timepoint [2] 339150 0
Baseline and end of treatment.
Primary outcome [3] 339148 0
Skeletal Effects of Class II orthopaedic treatment under the influence of mechanical vibration.
Timepoint [3] 339148 0
Baseline and end of orthopaedic treatment
Secondary outcome [1] 438769 0
Airway dimension changes following Class II orthopaedic treatment under the influence of vibration device
Timepoint [1] 438769 0
Base line and end of orthopaedic treatment

Eligibility
Key inclusion criteria
1. Class II division 1 malocclusion;
2. Overjet of at least 6mm;
3. ANB angle of 3.5 degrees or greater;
4. Permanent dentition;
5. No previous orthopaedic and orthodontic treatment;
6. Active pubertal growth
Minimum age
10 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Congenital syndromes
2. Obvious asymmetry
3. Temporomandibular joint disorder signs and symptoms

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)
allocation involved contacting the holder of teh allocation schedule who was "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculated with G*Power using previous similar literature as a guide.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/02/2018
Date of last participant enrolment
Anticipated
Actual
13/02/2024
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
60
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26965 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 43039 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 317220 0
University
Name [1] 317220 0
University of Sydney
Country [1] 317220 0
Australia
Primary sponsor type
Individual
Name
Lam Cheng - University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319495 0
Individual
Name [1] 319495 0
Prof M Ali Darendeliler - University of Sydney
Address [1] 319495 0
Country [1] 319495 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315957 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315957 0
Ethics committee country [1] 315957 0
Australia
Date submitted for ethics approval [1] 315957 0
14/11/2016
Approval date [1] 315957 0
10/02/2017
Ethics approval number [1] 315957 0
HREC/16/RPAH/681

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

Contacts
Principal investigator
Name 136338 0
Dr Lam Cheng
Address 136338 0
Sydney Dental Hosptial, Department of Orthodontics, Level 2, 2 Chalmers Street, Surry Hills NSW 2010
Country 136338 0
Australia
Phone 136338 0
+61 435003123
Fax 136338 0
Email 136338 0
[email protected]
Contact person for public queries
Name 136339 0
Lam Cheng
Address 136339 0
Sydney Dental Hosptial, Department of Orthodontics, Level 2, 2 Chalmers Street, Surry Hills NSW 2010
Country 136339 0
Australia
Phone 136339 0
+61 435003123
Fax 136339 0
Email 136339 0
[email protected]
Contact person for scientific queries
Name 136340 0
Lam Cheng
Address 136340 0
Sydney Dental Hosptial, Department of Orthodontics, Level 2, 2 Chalmers Street, Surry Hills NSW 2010
Country 136340 0
Australia
Phone 136340 0
+61 435003123
Fax 136340 0
Email 136340 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by -case basis at the discretion of the Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the (de-identificated) individual participant data collected during the trial will be shared

What types of analyses could be done with individual participant data?
• Meta-analysis or Systematic Review

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication and for 5 years follwing.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.