Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12612000593831
Ethics application status
Approved
Date submitted
8/05/2012
Date registered
1/06/2012
Date last updated
3/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Hall technique in preschool children
Scientific title
Effectiveness of a simplified method of managing carious primary molar teeth in preschool children using preformed metal crowns- (Hall technique) Phase 1
Secondary ID [1] 280364 0
nil
Universal Trial Number (UTN)
U1111-1130-1659
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 286337 0
Condition category
Condition code
Oral and Gastrointestinal 286581 286581 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
Modified stainless steel crown technique on primary molars
to seal in caries
Review 6 and 12 months after placement
Duration : 15 minutes on one visit
Intervention code [1] 284730 0
Treatment: Surgery
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287002 0
Percentage of failure at 12 months

Failure classified into major and minor failure

Abscess or irreversible pulpitis in the tooth with the Hall's crown will be classified as a 'Major failure', whilst 'minor failures' would be: caries at the margin of the crown, crown worn through, crown lost, first permanent molar impacting and separator placed.
A 'Successful' outcome is a tooth with a Hall crown that has neither a 'Major' or 'Minor' failure.
The assessment will be through both clinical and radiographic assessment
Timepoint [1] 287002 0
at 6 months and 12 months after placement of Hall crown
Secondary outcome [1] 297179 0
Acceptability of Hall technique to public oral health practitioners, preschool children and their primary carers
Assessment via questionaires administered verbally to primary carers and structured interviews with public oral health practitioners
Timepoint [1] 297179 0
at placement of Hall crowns and at 12 months after placement

Eligibility
Key inclusion criteria
greater than 3 years of age and less than 6 years of age
high risk of decay
co-operative for radiographs and treatment in dental clinic
Minimum age
36 Months
Maximum age
71 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
immunocompromised
at risk of infective endocarditis

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)
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
Active, not recruiting
Date of first participant enrolment
Anticipated
19/06/2012
Actual
19/06/2012
Date of last participant enrolment
Anticipated
Actual
5/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285146 0
Charities/Societies/Foundations
Name [1] 285146 0
Dental Health Services Victoria
Country [1] 285146 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Dental Health Services Victoria
Address
720 Swanston St
Carlton 3053
Victoria
Country
Australia
Secondary sponsor category [1] 284003 0
University
Name [1] 284003 0
The University of Melbourne
Address [1] 284003 0
720 Swanston Street
Parkville 3053
Victoria
Country [1] 284003 0
Australia
Secondary sponsor category [2] 284004 0
Other
Name [2] 284004 0
North Richmond Community Health Centre
Address [2] 284004 0
23 Lennox Street
Richmond 3121
Victoria
Country [2] 284004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287155 0
Dental Health Services Victoria Human Research Ethics Committee
Ethics committee address [1] 287155 0
Ethics committee country [1] 287155 0
Australia
Date submitted for ethics approval [1] 287155 0
Approval date [1] 287155 0
02/03/2012
Ethics approval number [1] 287155 0
247

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

Contacts
Principal investigator
Name 34093 0
A/Prof Hanny Calache
Address 34093 0
720 Swanston Street
Carlton
Victoria 3053
Country 34093 0
Australia
Phone 34093 0
+61 3 93411291
Fax 34093 0
Email 34093 0
[email protected]
Contact person for public queries
Name 17340 0
Rachel Martin
Address 17340 0
Dental Health Services Victoria
720 Swanston Street
Carlton 3053
Victoria
Country 17340 0
Australia
Phone 17340 0
61 3 9341 1720
Fax 17340 0
Email 17340 0
[email protected]
Contact person for scientific queries
Name 8268 0
Hanny Calache
Address 8268 0
Dental Health Services Victoria
720 Swanston Street
Carlton 3053
Victoria
Country 8268 0
Australia
Phone 8268 0
61 3 9341 1291
Fax 8268 0
Email 8268 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.