Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000980730
Ethics application status
Approved
Date submitted
27/08/2013
Date registered
3/09/2013
Date last updated
3/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a simplified method of managing carious primary molar teeth in young children using preformed metal crowns- Phase 2
Scientific title
Effectiveness of a simplified method of managing carious primary molar teeth in young children using preformed metal crowns-The Hall Technique - Phase 2
Secondary ID [1] 283092 0
nil
Universal Trial Number (UTN)
U1111-1147-2505
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 289925 0
Condition category
Condition code
Oral and Gastrointestinal 290300 290300 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 290352 290352 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
modified stainless steel crown technique on primary molars to seal caries, ie the Hall Technique. Placed on one tooth on one occasion per child
review at 6, 12 and 24 months
technique takes approximately 15 minutes
Intervention code [1] 287805 0
Treatment: Surgery
Comparator / control treatment
no conrol group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290333 0
The success rate will be measured in terms of numbers of years per tooth free of re-treatment over 24 months. Re-treatment consists of any subsequent treatment on the tooth after baseline treatment.
Timepoint [1] 290333 0
6, 12 and 24 months after placement of Hall Technique crowns
Secondary outcome [1] 304315 0
Acceptability of Hall Technique to public oral health practitioners, their patients and the parents and primary carers of the patients. This will be measured via questionnaires at baseline (Hall Technique Crown placement), 6, 12 and 24 months
Timepoint [1] 304315 0
questionnaires at baseline (Hall Technique Crown placement), 6, 12 and 24 months

Eligibility
Key inclusion criteria
greater than 3 years of age
less than 8 years of age
high risk to dental decay
co-operative for dental treatment in the chair
Minimum age
36 Months
Maximum age
95 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
immuno-compromised
cardiac conditions

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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7290 0
3121 - Richmond
Recruitment postcode(s) [2] 7291 0
3175 - Dandenong
Recruitment postcode(s) [3] 7292 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 287846 0
Charities/Societies/Foundations
Name [1] 287846 0
William Buckland Foundation, ANZ Trustees
Country [1] 287846 0
Australia
Primary sponsor type
Other
Name
North Richmond Community Health Centre Inc
Address
23 Lennox St
Richmond
VIC 3121
Country
Australia
Secondary sponsor category [1] 286576 0
Government body
Name [1] 286576 0
Dental Health Services Victoria
Address [1] 286576 0
720 Swanston St
Carlton
VIC 3053
Country [1] 286576 0
Australia
Other collaborator category [1] 277586 0
University
Name [1] 277586 0
Melbourne Dental School
University of Melbourne
Address [1] 277586 0
720 Swanston St
Carlton
VIC 3053
Country [1] 277586 0
Australia
Other collaborator category [2] 277587 0
Government body
Name [2] 277587 0
Barwon Health
Oral Health Services
Address [2] 277587 0
104 – 108 Bellarine Highway, Newcomb, Vic, 3219
Country [2] 277587 0
Australia
Other collaborator category [3] 277588 0
Government body
Name [3] 277588 0
Monash Health
Oral Health Services
Address [3] 277588 0
3/229 Thomas St
Dandenong
VICTORIA 3175
Country [3] 277588 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289788 0
Dental Health Services Human Research Ethics Committee
Ethics committee address [1] 289788 0
720 Swanston St
Carlton
VICTORIA 3053
Ethics committee country [1] 289788 0
Australia
Date submitted for ethics approval [1] 289788 0
Approval date [1] 289788 0
07/08/2013
Ethics approval number [1] 289788 0
270

Summary
Brief summary
Dental decay (caries) is a highly prevalent disease in Australia and Early Childhood Caries (ECC) is one of the most common chronic diseases of childhood. ECC is the presence of any decayed, missing (due to decay) or filled surface in primary (deciduous) teeth in children 6 years or less. ECC has wide-ranging health and developmental consequences and is often associated with pain, infection and abscesses which can lead to delayed growth, reduced general health, sleep problems and disrupted social and academic development due to school absences. In Australia the epidemiological and service data on prevalence and morbidity for child oral health is patchy; with only 2002 national data available. In 2002 Australian children 0-4 years in the National Child Oral Health survey had a mean of 1.55 decayed, missing or filled teeth (dmft) and 80% of this was active, untreated decay. Of those children with decay (44%), the mean dmft per child was 4.23.
In 2006, the Victorian Child Health and Wellbeing Survey found that 21% of 0-3 year olds had experienced toothache and Victorian data available from DHSV shows that of children aged 0-6 years attending public dental clinics in 2009 (n=14,911), 47% had tooth decay (n=7,072), with an average dmft of 2.2.
Dental treatment was the 3rd most common cause of hospitalisation for 0-14 year olds in Australia in 2009-10 and the average cost per admission for extractions and restorations was AUD$2508 per child. Importantly the severity of the disease in young children may be increasing as there was a 53% increase in dental Ambulatory Care Sensitive Conditions (ACSC) admissions from 1997/8 to 2004/5 for 0–9 year-olds, with an average annual increase of 7.6%. However, caries rates are higher among the more socially disadvantaged, particularly in childhood, and amongst those living in rural and regional areas. This is also reflected in the ACSC data and rural children have dental related hospital admission rates that are 4 times higher than metropolitan children.
After tooth extraction, the potential impacts on child social, emotional, nutritional and developmental experiences are considerable.
The significance of this project is to test the effectiveness of a simplified method, reported in the literature, for managing carious primary molar teeth in preschool children without any tooth preparation or local analgesia and therefore making treatment more acceptable to preschool children in a primary care setting. If the approach were shown to be effective, the expected long term outcome would be a reduction in hospital admissions for the management of dental caries in this age group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42418 0
A/Prof Hanny Calache
Address 42418 0
Dental Health Services Victoria

720 Swanston St Carlton 3053
Country 42418 0
Australia
Phone 42418 0
+61 3 9341 1291
Fax 42418 0
+61 3 9341 1234
Email 42418 0
[email protected]
Contact person for public queries
Name 42419 0
Dr Rachel Martin
Address 42419 0
Dental Health Services Victoria

720 Swanston St Carlton 3053
Country 42419 0
Australia
Phone 42419 0
+61 3 9341 1720
Fax 42419 0
Email 42419 0
[email protected]
Contact person for scientific queries
Name 42420 0
A/Prof Hanny Calache
Address 42420 0
Dental Health Services Victoria

720 Swanston St Carlton 3053
Country 42420 0
Australia
Phone 42420 0
+61 3 9341 1291
Fax 42420 0
Email 42420 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

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