ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

U1111-1130-1659

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

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]

Treatment: Surgery

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

at 6 months and 12 months after placement of Hall crown

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Dental Health Services Victoria

Address [1]

720 Swanston St
Carlton 3053
Victoria

Country [1]

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]

University

Name [1]

The University of Melbourne

Address [1]

720 Swanston Street
Parkville 3053
Victoria

Country [1]

Australia

Secondary sponsor category [2]

Other

Name [2]

North Richmond Community Health Centre

Address [2]

23 Lennox Street
Richmond 3121
Victoria

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Dental Health Services Victoria Human Research Ethics Committee

Ethics committee address [1]

720 Swanston Street
Carlton 3053
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/03/2012

Ethics approval number [1]

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

A/Prof Hanny Calache

Address

720 Swanston Street
Carlton
Victoria 3053

Country

Australia

Phone

+61 3 93411291

Fax

hanny.calache@dhsv.org.au

Contact person for public queries

Name

Rachel Martin

Address

Dental Health Services Victoria
720 Swanston Street
Carlton 3053
Victoria

Country

Australia

Phone

61 3 9341 1720

Fax

rachel.martin@dhsv.org.au

Contact person for scientific queries

Name

Hanny Calache

Address

Dental Health Services Victoria
720 Swanston Street
Carlton 3053
Victoria

Country

Australia

Phone

61 3 9341 1291

Fax

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.

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