Trial Review

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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
720 Swanston Street
Carlton 3053
Victoria
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
There are a large number of disadvantaged pre-school children who suffer tooth decay. Unfortunately, many of them require extensive treatment necessitating general anaesthesia with its risks and high costs. Preformed stainless steel crowns are the best method of restoring decayed baby molar teeth and a simplified method of placing them, without using general anaesthesia, has been found to be successful with school age children. We wish to test whether this method would be successful with pre-school children at high risk to dental caries in a community dental clinic at a success rate comparable to conventionally placed stainless steel crowns.
Research Investigators include the Director of Clinical Leadership, Education and Research of Dental Health Services Victoria; senior academic staff of the Melbourne Dental School, University of Melbourne; the Manager Oral Health Program North Richmond Community Health, and a senior dentist from the North Richmond Community Dental Clinic. Participants will include North Richmond Community Health management and staff, preschool children patients (and their primary carers) of the North Richmond Community Dental Clinic. As part of the standard clinical care for patients at high risk to dental caries, the preschool children will have x-rays taken beforehand to diagnose decay and exclude from the study patients with extensive disease for which this treatment is not indicated. Multi-language brochures and dental examination with questionnaire will precede an interview to elicit verbal and written consent. Immediately after treatment, carers will be asked to fill in another questionnaire. At the 12 months review visit another x-ray will be taken, again according to standard clinical care for patients at high risk to dental caries, and a further questionnaire filled. The prime statistic will be the number of crowns deemed to be a success at six months, and 12 months (for Phase 1 of the study), using criteria established by previous research. Secondary findings will be the acceptance of this mode by patients, carers and staff.
A key aspect is that, in appropriately selected cases, this treatment does not drill out any of the decay; so, does not require any injection of local analgesia, is less uncomfortable, and so is faster and likely to be better tolerated by pre-school children than conventional stainless steel crowns. A key issue is ascertaining that there is no unexpected progression of decay with poor outcomes. Research has shown that the decay of deciduous molars that is isolated under the crowns ceases and causes no further destruction to the teeth.
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
hanny.calache@dhsv.org.au
Contact person for public queries
Name 17340 0
Dr 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
rachel.martin@dhsv.org.au
Contact person for scientific queries
Name 8268 0
A/Prof 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
Hanny.Calache@dhsv.org.au

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.