Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000205033
Ethics application status
Not yet submitted
Date submitted
8/03/2010
Date registered
10/03/2010
Date last updated
10/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of skeletal 2 malocclusions with temporary anchorage devices and elastics.
Scientific title
Treatment of skeletal 2 malocclusion in growing patients (assessed to be in cervical stage 3-4 of skeletal development from a lateral cephalograph x-ray) using an appliance joined to temporary anchorage devices and using class II elastics.
Secondary ID [1] 1474 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Class 2 malocclusion - dental and skeletal
with mandibular deficiency 256923 0
Condition category
Condition code
Oral and Gastrointestinal 257068 257068 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
2 orthodontic miniscrews are to be placed in the palate of the upper jaw which is joined to an expansion appliance cemented to the patient's upper posterior teeth.
4 orthodontic miniscrews - 2 on each side joined by a plate - will be placed in the lower jaw. The patient will be required to wear class II elastics from the upper appliance to the lower joined miniscrews. This procedure is expected to take approximately 1 hour.
The miniscrews and expansion appliance will be placed at the start of treatment and is expected to stay in the mouth for approximately 9 months. Miniscrews will only be replaced if they fail. Current research literature states a 80-85% success rate for orthodontic miniscrews.
At the end of 9 months of treatment, all miniscrews and the expansion appliance will be removed from the patient
Intervention code [1] 256116 0
Treatment: Devices
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257963 0
Millimetric measurement of the correction of class II malocclusion and treatment effects of the appliance with temporary anchorage devices and elastics.
Timepoint [1] 257963 0
Records will be taken at the start of treatment at T-0. The patient will be seen every 4-6 weeks for adjustments.
Treatment is estimated to take at least 9months until class I occlusion is achieved
Secondary outcome [1] 263496 0
Nil
Timepoint [1] 263496 0
Nil

Eligibility
Key inclusion criteria
1.Cervical stage 3-4 skeletal developement (Baccetti et al 1995)
2.Have a Class II dental and skeletal relationship with mandibular deficiency
3.Permanent dentition
4.No previous orthodontic treatment, trauma and no dental or congenital anomalies
5.Good oral hygiene and no periodontal disease.
Minimum age
5 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medically compromised patients.
2. patients with a history of poor compliance and will not wear elastics
3. Patients with active dental or gum disease
4. Patients with poor oral hygiene
5. Patients that do not wish to volunteer for the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be chosen by Prof Darendeliler, Dr Daniel Tan, Dr Gonzales, Dr Tarraf and Dr Dalci from those that have been referred to the Department of Orthodontics in Sydney Dental Hospital for the correction of their skeletal II malocclusion and which have been placed on the Department’s waiting list. Patients that fulfil the following criteria:
1.Cervical stage 3-4 (Baccetti et al 1995)
2.Have a Class II dental and skeletal relationship with mandibular deficiency
3.Permanent dentition
4.No previous orthodontic treatment, trauma and no dental or congenital anomalies
5.Good oral hygiene and no periodontal disease.

Will be chosen to voluntarily be included in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256612 0
Charities/Societies/Foundations
Name [1] 256612 0
Australian Society of Orthodontists
Country [1] 256612 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Society of Orthodontists
Address
PO Box 576
Crows Nest NSW 1585
Australia
Country
Australia
Secondary sponsor category [1] 255903 0
None
Name [1] 255903 0
Address [1] 255903 0
Country [1] 255903 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258652 0
Sydney South West Area Health Service - Human Research Ethics Committee (SSWAHS HREC)
Ethics committee address [1] 258652 0
Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 258652 0
Australia
Date submitted for ethics approval [1] 258652 0
31/03/2010
Approval date [1] 258652 0
Ethics approval number [1] 258652 0

Summary
Brief summary
This study will investigate the results of a new functional appliance which aims to correct skeletal 2 malocclusions. Currently, controversy exists on the efficacy of functional appliances at stimulating mandibular growth. This is because the tooth movements rather than changes in facial growth have found to be mostly responsible for the improvement seen in the dental arch relationships. This appliance will be attached to orthodontic miniscrew temporary anchorage devices aimed at achieving maximal skeletal correction of their malocclusion and minimising dentoalveolar effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30906 0
Address 30906 0
Country 30906 0
Phone 30906 0
Fax 30906 0
Email 30906 0
Contact person for public queries
Name 14153 0
Daniel Tan
Address 14153 0
Discipline of Orthodontics, Sydney Dental Hospital, 2 Chalmers Street
Surry Hills NSW 2010
Country 14153 0
Australia
Phone 14153 0
+61 2 92933388
Fax 14153 0
+61 2 9351 8336
Email 14153 0
[email protected]
Contact person for scientific queries
Name 5081 0
Daniel Tan
Address 5081 0
Discipline of Orthodontics, Sydney Dental Hospital, 2 Chalmers Street
Surry Hills NSW 2010
Country 5081 0
Australia
Phone 5081 0
+61 2 9293 3388
Fax 5081 0
+61 2 9351 8336
Email 5081 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.