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Trial registered on ANZCTR


Registration number
ACTRN12610000220066
Ethics application status
Not yet submitted
Date submitted
9/03/2010
Date registered
17/03/2010
Date last updated
17/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of skeletal class III malocclusions with temporary anchorage devices and class III elastics
Scientific title
The effect of skeletal anchorage with temporary anchorage devices and class II elastics versus conventional extraoral headgear therapy on the degree and time to skeletal change in children with a skeletal class II malocclusion and a retrusive maxilla
Secondary ID [1] 1471 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skeletal class III malocclusions with retrusive maxillae 256929 0
Condition category
Condition code
Oral and Gastrointestinal 257072 257072 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
The participants will have miniscrews placed into their upper and lower jaws. These will then be loaded with class III elastic bands. The miniscrews will be placed under local anaesthetic.This procedure will take approximately 30 minutes. The treatment affects of this will be compared after 10 months of treatment to assess how much protraction of the maxilla has occured.
Intervention code [1] 256119 0
Treatment: Devices
Comparator / control treatment
This include standard care of the patient where the upper jaw is protracted to a position where it is in front of the lower jaw. This is ususally done with an extraoral protraction facemask, which takes 30 minutes to place, or sugery when their growth has ceased
Control group
Active

Outcomes
Primary outcome [1] 257969 0
A more pronounced skeletal change will be evident in less treatment time. This will be assessed via clinical measurements of overbite and overjet and also using radiology in the form of 3D Newtom scans used routinely as part of orthodontic treatment
Timepoint [1] 257969 0
Treatment time is 10 months. The baseline will be when the protraction is started. The endpoint will be when an overjet of 3mm is achieved which should be at 10 months of treatment
Secondary outcome [1] 263503 0
Nil
Timepoint [1] 263503 0
Nil

Eligibility
Key inclusion criteria
Children between the ages of 9 and 13 years
Skeletal class 3 malocclusions with retrusive maxillae with their lower canines erupted
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lower permanent canines have not erupted
Patient above 13 years old with fusion of their circummaxillary sutures

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)
The subjects will be enrolled from the University of Sydney, Orthodontic department waiting list. The subjects wiill be selected based on the clinical examination performed by 3 clinicians who independantly assess the patient and confirm their eligibility for the study. The patients who fulfill the selection criteria will be allocated to the intervention treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
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
1/05/2010
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] 256616 0
Charities/Societies/Foundations
Name [1] 256616 0
Australian Society of Orthodontists
Country [1] 256616 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Society of Orthodontists
Address
Australian Society of Orthodontists Inc
PO Box 576
Crows Nest NSW 1585
Australia
Country
Australia
Secondary sponsor category [1] 255906 0
Hospital
Name [1] 255906 0
Sydney Dental Hospital
Address [1] 255906 0
Sydney Dental Hospital
2 Chalmers street
Surry Hills
NSW 2010
Country [1] 255906 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258646 0
Ethics committee address [1] 258646 0
Ethics committee country [1] 258646 0
Date submitted for ethics approval [1] 258646 0
11/03/2010
Approval date [1] 258646 0
Ethics approval number [1] 258646 0

Summary
Brief summary
The primary purpose of the study is to develop an alternative to the conventional facemask protraction therapy in the treatment of skeletal class III malocclusion. The hypothesis is that the treatment of skeletal class III malocclusions with miniscrews and intraoral elastics will produce a more profound skeletal change in less time than the conventional therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30910 0
Address 30910 0
Country 30910 0
Phone 30910 0
Fax 30910 0
Email 30910 0
Contact person for public queries
Name 14157 0
SAAD AL-MOZANY
Address 14157 0
Orthodontic department
Level 2
Sydney Dental Hospital
2 Chalmers street
Surry Hills
NSW 2010
Country 14157 0
Australia
Phone 14157 0
+61450900575
Fax 14157 0
Email 14157 0
[email protected]
Contact person for scientific queries
Name 5085 0
SAAD AL-MOZANY
Address 5085 0
Orthodontic department
Level 2
Sydney Dental Hospital
2 Chalmers street
Surry Hills
NSW 2010
Country 5085 0
Australia
Phone 5085 0
+61450900575
Fax 5085 0
Email 5085 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
SourceTitleYear of PublicationDOI
EmbaseA novel method for treatment of Class III malocclusion in growing patients.2017https://dx.doi.org/10.1186/s40510-017-0192-y
Dimensions AIEffects of hybrid-Hyrax, Alt-RAMEC and miniscrew reinforced heavy Class III elastics in growing maxillary retrusive patients. A four-year follow-up pilot study2017https://doi.org/10.21307/aoj-2020-099
Embase3D effects of a bone-anchored intra-oral protraction in treating class III growing patient: a pilot study.2019https://dx.doi.org/10.1186/s40510-019-0290-0
N.B. These documents automatically identified may not have been verified by the study sponsor.