ANZCTR - Registration

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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

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]

nil

Universal Trial Number (UTN)

U1111-1147-2505

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

dental caries

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Public Health

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]

Treatment: Surgery

Comparator / control treatment

no conrol group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

6, 12 and 24 months after placement of Hall Technique crowns

Secondary outcome [1]

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]

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]

3121 - Richmond

Recruitment postcode(s) [2]

3175 - Dandenong

Recruitment postcode(s) [3]

3220 - Geelong

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

William Buckland Foundation, ANZ Trustees

Address [1]

42/55 Collins St Melbourne GPO box 389 Melbourne VICTORIA 3001

Country [1]

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]

Government body

Name [1]

Dental Health Services Victoria

Address [1]

720 Swanston St Carlton VIC 3053

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Melbourne Dental School University of Melbourne

Address [1]

720 Swanston St Carlton VIC 3053

Country [1]

Australia

Other collaborator category [2]

Government body

Name [2]

Barwon Health Oral Health Services

Address [2]

104 – 108 Bellarine Highway, Newcomb, Vic, 3219

Country [2]

Australia

Other collaborator category [3]

Government body

Name [3]

Monash Health Oral Health Services

Address [3]

3/229 Thomas St Dandenong VICTORIA 3175

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Dental Health Services Human Research Ethics Committee

Ethics committee address [1]

720 Swanston St
Carlton 
VICTORIA 3053

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/08/2013

Ethics approval number [1]

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

A/Prof Hanny Calache

Address

Dental Health Services Victoria 720 Swanston St Carlton 3053

Country

Australia

Phone

+61 3 9341 1291

Fax

+61 3 9341 1234

[email protected]

Contact person for public queries

Name

Rachel Martin

Address

Dental Health Services Victoria 720 Swanston St Carlton 3053

Country

Australia

Phone

+61 3 9341 1720

Fax

[email protected]

Contact person for scientific queries

Name

Hanny Calache

Address

Dental Health Services Victoria 720 Swanston St Carlton 3053

Country

Australia

Phone

+61 3 9341 1291

Fax

[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.

Trial Review

Documents added manually

Documents added automatically