Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000154000
Ethics application status
Not yet submitted
Date submitted
1/02/2010
Date registered
16/02/2010
Date last updated
16/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of the Sydney Intrusion Spring (SIS) on the maxillary posterior dental segments with the application of an intrusive force.
Scientific title
The effects of the Sydney Intrusion Spring (SIS) on the amount and rate of intrusion with closure of the anterior open bite after the application of an intrusive force in 12-14 yr old children with maxillary transverse deficiency and skeletal anterior open bite malocclusion.
Secondary ID [1] 1410 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skeletal open bite malocclusion 256706 0
Condition category
Condition code
Oral and Gastrointestinal 256861 256861 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
Sydney Intrusion Spring, Miniscrew skeletal anchorage, Bonded Hyrax rapid maxillary expander will be placed at the start of the intervention. These appliances are all well established and commonly used in clinical orthodontic practice. The SIS will provide a continous intrusive force to the maxillary posterior teeth from the start to the end of the intervention. Measurements for amount and rate of intrusion will be taken at 6 weekly intervals. Anticipated duration of the intervention is 6-9 months, depending on the severity of the initial open bite.
Intervention code [1] 255937 0
Treatment: Devices
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257730 0
Millimetric measurement of the maxillary posterior teeth intrusion.
Timepoint [1] 257730 0
Millimetric measurements of the open bite will be taken at T=0 and then at 6 weekly intervals until a 2 mm over bite is achevied
Secondary outcome [1] 263096 0
Reduction of the anterior over bite will be assesed making millimetric measurements across the upper and lower incisor teeth teeth using digital callipers.
Timepoint [1] 263096 0
Millimetric measurements of the open bite will be taken at T=0 and then at 6 weekly intervals until a 2 mm over bite is achevied

Eligibility
Key inclusion criteria
Skeletal and dental open bite malocclusion
Makillary transverse deficiency.
Increased lower face height.
Adequate or excessive incisor display on smiling.
Convex facial profile
No non-nutritive sucking habits.
No severe posterior crowding.
Permanent dentition
No previous orthodontic treatment, trauma and no dental or congenital anomalies.
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
Non-nutritive sucking habits.
Inadequate incisor display on smiling.
Straight to concave facial profile.
Mixed dentition.
Poor oral hygiene and periodontal disease

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)
Subjects will be chosen by the invesigators from those that have been referred to the Department of Orthodontics in Sydney Hospital for treatment of their Skeletal anterior open bite malocclusion and that have been placed on the Department's waiting list.If enough patients that fulfill the criteria cannot be found from the waiting list, new patients will be recruited.
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
Safety/efficacy
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
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256447 0
Charities/Societies/Foundations
Name [1] 256447 0
Australian Society of Orthodontists
Country [1] 256447 0
Australia
Funding source category [2] 256448 0
University
Name [2] 256448 0
Department of Orthodontics, University of Sydney
Country [2] 256448 0
Australia
Primary sponsor type
University
Name
Department of Orthodontics, University of Sydney
Address
Department of Orthodontics
Level 2
Sydney Dental Hospital
2 Chalmers St
Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 255747 0
Charities/Societies/Foundations
Name [1] 255747 0
Australian Society of Orthodontists
Address [1] 255747 0
PO Box 576
Crows Nest
NSW 1585
Country [1] 255747 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258502 0
Sydney South West Area Health Services (SSWAHS) [Royal Prince Alfred (RPA) zone] Ethics review committee
Ethics committee address [1] 258502 0
c/- Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Ethics committee country [1] 258502 0
Australia
Date submitted for ethics approval [1] 258502 0
10/03/2010
Approval date [1] 258502 0
Ethics approval number [1] 258502 0

Summary
Brief summary
Skeletal anterior open bite malocclusion is one of the most difficult malocclusions to treat orthodontically. Traditional treatment was aimed at correcting the malocclusion through a combination of orthodontics and orthognathic surgery, once growth was completed. Although good results were achieved, the treatment was complicated and severe invasive. With the advent of skeletal anchorage and miniscrews it has now become possible to treat Skeletal anterior open bite malocclusions non-surgically through intrusion of the maxillary posterior teeth, resulting in the closure of the anterior open bite. However, the appliances currently used for the intrusion are crude adaptions of existing auxillaries, not meant for this purpose. The have significant short comings including tissue irritaion, trauma and the need for frequent reactivation. The Sydney Intrusion Spring (SIS) is an appliance that has been specifically designed for the intrusion of maxillary posterior teeth. The aim of the study is to analyse the efficacy of this appliance on the intrusion of maxillary posterior teeth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30784 0
Address 30784 0
Country 30784 0
Phone 30784 0
Fax 30784 0
Email 30784 0
Contact person for public queries
Name 14031 0
Dr Riaan Foot
Address 14031 0
Department of Orthodontics
Level 2
Sydney Dental Hospital
2 Chalmers St
Surry Hills
NSW 2010
Country 14031 0
Australia
Phone 14031 0
+61 2 9351 8314
Fax 14031 0
+61 2 9351 8336
Email 14031 0
[email protected]
Contact person for scientific queries
Name 4959 0
Dr Riaan Foot
Address 4959 0
Department of Orthodontics
Level 2
Sydney Dental Hospital
2 Chalmers St
Surry Hills
NSW 2010
Country 4959 0
Australia
Phone 4959 0
+61 2 9351 8314
Fax 4959 0
+61 2 9351 8336
Email 4959 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.