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The clinical effects of the use of mechanical vibration device in conjunction with orthopaedic appliance in correction of mandibular retrusion

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000194460
Enrollment
50
Registered
2025-02-19
Start date
2018-02-05
Completion date
2024-02-13
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 experi

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.

Sponsors

Lam Cheng - University of Sydney
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years
Healthy volunteers
No

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

Exclusion criteria

1. Congenital syndromes 2. Obvious asymmetry 3. Temporomandibular joint disorder signs and symptoms

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026