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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
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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
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Secondary ID [1]
312789
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Class II Malocclusion
334850
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Condition category
Condition code
Oral and Gastrointestinal
331400
331400
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329315
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
339149
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Dental effects of Class II orthopaedic appliance under influence of mechanical vibration
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Assessment method [1]
339149
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CBCT taken at beginning and end of treatment with cephalometric analysis measuring the following parameters: Overjet Overbite Upper incisor inclination to cranial base Lower incisor inclination to mandibular plane Pancherz analysis This will be assessed as a composite outcome
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Timepoint [1]
339149
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Baseline and end of orthopaedic treatment
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Primary outcome [2]
339150
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Soft tissue changes following Class II orthopaedic treatment under the influence of vibration device
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Assessment method [2]
339150
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CBCT and cephalometric analysis of the following parameters: Upper lip to S-line Lower lip to S-line Nasolabial angle This will be assessed as a composite outcome
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Timepoint [2]
339150
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Baseline and end of treatment.
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Primary outcome [3]
339148
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Skeletal Effects of Class II orthopaedic treatment under the influence of mechanical vibration.
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Assessment method [3]
339148
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Cone beam computed tomography (CBCT) will be taken before and after treatment with cephalometric analysis measuring the folllowing parameters: Maxilla position in relation to cranial base (SNA) Mandible position in relation to cranial base (SNB) Maxillomandibular relation (ANB) Wits appraisal Maxilla position to Nasion perpendicular Pogonion position to Nasion perpendicular Mandibular length (Co-Gn) Mandibular plane angle (SN-GoMe) Growth direction (Y-axis) This will be assessed as a composite outcome
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Timepoint [3]
339148
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Baseline and end of orthopaedic treatment
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Secondary outcome [1]
438769
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Airway dimension changes following Class II orthopaedic treatment under the influence of vibration device
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Assessment method [1]
438769
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CBCT and Dolphin software with 3D analysis of the following parameters: Volume of Nasopharynx Volume of Oropharynx Minimal cross-sectional area This will be assessed as a composite outcome
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Timepoint [1]
438769
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Base line and end of orthopaedic treatment
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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
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Minimum age
10
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Congenital syndromes
2. Obvious asymmetry
3. Temporomandibular joint disorder signs and symptoms
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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".
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Sample size calculated with G*Power using previous similar literature as a guide.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
5/02/2018
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Date of last participant enrolment
Anticipated
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Actual
13/02/2024
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Date of last data collection
Anticipated
28/02/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
26965
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Sydney Dental Hospital - Surry Hills
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Recruitment postcode(s) [1]
43039
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2010 - Surry Hills
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Funding & Sponsors
Funding source category [1]
317220
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University
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Name [1]
317220
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University of Sydney
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Address [1]
317220
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Country [1]
317220
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Australia
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Primary sponsor type
Individual
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Name
Lam Cheng - University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
319495
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Individual
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Name [1]
319495
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Prof M Ali Darendeliler - University of Sydney
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Address [1]
319495
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Country [1]
319495
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315957
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
315957
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https://www.slhd.nsw.gov.au/rpa/research/
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Ethics committee country [1]
315957
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Australia
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Date submitted for ethics approval [1]
315957
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14/11/2016
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Approval date [1]
315957
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10/02/2017
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Ethics approval number [1]
315957
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HREC/16/RPAH/681
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Summary
Brief summary
This study investigates the impact of mechanical vibration on the dental and skeletal effects of different orthopaedic appliance therapies at different skeletal maturities. Orthopaedic appliance therapies are best treated while there is still growth potential at the cartilage but some patients may have missed the ideal treatment period or they are towards the end of growth potential. As a result, these patients may face orthognathic surgery to achieve skeletal correction. The results of this study may shed light on whether these patients who are towards the end of their growth can still be treated orthopaedically which in turns may lead in the avoidance of orthognathic surgery in the future. The hypothesis is that there is no statistically significant difference in the dental and skeletal effects from Class II orthopaedic appliance therapy with mechanical vibration between two different skeletal maturity status.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
136338
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Dr Lam Cheng
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Address
136338
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Sydney Dental Hosptial, Department of Orthodontics, Level 2, 2 Chalmers Street, Surry Hills NSW 2010
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Country
136338
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Australia
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Phone
136338
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+61 435003123
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Fax
136338
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Email
136338
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[email protected]
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Contact person for public queries
Name
136339
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Lam Cheng
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Address
136339
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Sydney Dental Hosptial, Department of Orthodontics, Level 2, 2 Chalmers Street, Surry Hills NSW 2010
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Country
136339
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Australia
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Phone
136339
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+61 435003123
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Fax
136339
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Email
136339
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[email protected]
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Contact person for scientific queries
Name
136340
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Lam Cheng
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Address
136340
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Sydney Dental Hosptial, Department of Orthodontics, Level 2, 2 Chalmers Street, Surry Hills NSW 2010
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Country
136340
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Australia
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Phone
136340
0
+61 435003123
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Fax
136340
0
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Email
136340
0
[email protected]
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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.
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