Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000298011
Ethics application status
Not yet submitted
Date submitted
23/02/2010
Date registered
13/04/2010
Date last updated
13/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a newly designed stepwise functional appliance on growth and development in Class II mandibular deficient patients.
Scientific title
The effects on growth and development of a newly designed stepwise functional appliance in Class II mandibular deficient patients.
Secondary ID [1] 1476 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Class II mandibular deficiency. 256795 0
Condition category
Condition code
Oral and Gastrointestinal 256946 256946 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 257077 257077 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The device is a functional applicance made from a stainless steel casing and acrylic which houses a small magnet. The device is cemented onto the occlusal surfaces of the posterior teeth and with the use of magnetic forces moves the lower jaw forward. The amount of movment of the jaw is determined by another magnetic plate which is designed so that the magnet is placed at 3mm intervals which will act to move the lower jaw forward in 3mm incremental steps. The device is worn in the mouth for 9 months.
Intervention code [1] 256003 0
Treatment: Devices
Comparator / control treatment
No treatment control group and twin block control group as assessed by two other studies.

No other functional appliance is used in the study, only information from other studies previously done is used.

The source of the historical data is several published journal articles and they range in time from 1980 to 2010
Control group
Historical

Outcomes
Primary outcome [1] 257823 0
Reduced overjet and protrusion of the mandible within normal limits as assessed by cephalometric measurements, 3DMD photography and other radiographic evidence.
Timepoint [1] 257823 0
18 months following intervention commencement.
Secondary outcome [1] 263240 0
Nil
Timepoint [1] 263240 0
Nil

Eligibility
Key inclusion criteria
1. Aged between 12 and 14.
2. Have a Class II dental and skeletal relationship with mandibular deficiency
3. Decreased lower facial height
4. Permanent dentition
5. No severe posterior crowding
6. No previous orthodontic treatment, trauma and no dental or congenital anomalies
7. Good oral hygiene and no periodontal disease.
Minimum age
12 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe crowding

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)
Patients are selected randomly from the computerised waitlist at Sydney Dental Hospital. Patients have previously been screened and determined as requiring orthodontic treatment for Class II malocclusion.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
list generated randomly from computerised waiting list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256507 0
University
Name [1] 256507 0
The University of Sydney, Faculty of Dentistry
Country [1] 256507 0
Australia
Primary sponsor type
University
Name
The University of Sydney, Faculty of Dentistry
Address
Sydney Dental Hospital
Level 2, 2 Chalmers Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 255817 0
None
Name [1] 255817 0
Address [1] 255817 0
Country [1] 255817 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258554 0
Ethics committee address [1] 258554 0
Ethics committee country [1] 258554 0
Date submitted for ethics approval [1] 258554 0
19/01/2010
Approval date [1] 258554 0
Ethics approval number [1] 258554 0

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

Contacts
Principal investigator
Name 30828 0
Address 30828 0
Country 30828 0
Phone 30828 0
Fax 30828 0
Email 30828 0
Contact person for public queries
Name 14075 0
Shahrzad Khayami
Address 14075 0
Sydney Dental Hospital
Department of Orthodontics
Level 2, 2 Chalmers Street
Sydney NSW 2000
Country 14075 0
Australia
Phone 14075 0
+61 2 9293 3333
Fax 14075 0
Email 14075 0
[email protected]
Contact person for scientific queries
Name 5003 0
Shahrzad Khayami
Address 5003 0
Sydney Dental Hospital
Department of Orthodontics
Level 2, 2 Chalmers Street
Sydney NSW 2000
Country 5003 0
Australia
Phone 5003 0
+61 2 9293 3333
Fax 5003 0
Email 5003 0
[email protected]

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.