Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000473965
Ethics application status
Approved
Date submitted
5/05/2011
Date registered
6/05/2011
Date last updated
11/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is silver fluoride effective in managing deciduous caries?
Scientific title
Children in remote Aboriginal communities with silver fluoride applications compared with conventional atraumatic restorative technique in managing deciduous dental caries
Secondary ID [1] 262118 0
Nil
Universal Trial Number (UTN)
U1111-1121-1782
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 265796 0
Condition category
Condition code
Oral and Gastrointestinal 265950 265950 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
Application of silver fluoride on tooth surfaces affected by dental decay.
Silver fluoride (40% AgF and stannous fluoride 10%) in liquid form.
A small amount of silver fluoride is painted onto tooth surfaces with a small brush.
Applications are performed once every 8 months, ie, at the baseline , 8 months and 16 months.
Maximum three applications per child during the study period.
The follow-up examination is at 24 months.
Intervention code [1] 264534 0
Treatment: Other
Intervention code [2] 264543 0
Prevention
Comparator / control treatment
Standard treatment:
Conventional atraumatic restorative technique with Glass-Iono-Cement (GIC) dental materials.
GICs are common dental materials that attach to tooth surfaces by chemical bonding. It can release fluoride.
Control group
Active

Outcomes
Primary outcome [1] 266701 0
Failure of treatment: % with pain, abscess, extractions, mean number of tooth surfaces with failure of treatment.

Outcome will be assessed by clinical assessment and information collection from patients' case notes.
Timepoint [1] 266701 0
2 years
Secondary outcome [1] 276220 0
Number of new carious lesions.

Estimated by comparing the information collected in clinical assessments at baseline and follow-up.
Net caries increment will be estimated using the standard method in longitudinal dental caries research (Slade et al, Community Dent Oral Epidemiol 1999; 27: 236-48).
New carious events are defined as change from perviously sound tooth surface to decayed, filled or missing because of decay tooth surfaces.
Timepoint [1] 276220 0
2 years

Eligibility
Key inclusion criteria
Age 4 to 8 years.
Having at least one deciduous tooth with decay.
Minimum age
4 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe general health condition;
Suspected allergy to components of the intervention

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clustered randomised controlled trial:
Children will be randomly assigned by community to receive one of the two interventions.
Communities will be matched by size and randomly allocated at The University of Adelaide into the AgF and ART intervention communities.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
2/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
304
Accrual to date
271
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 265021 0
Government body
Name [1] 265021 0
National Health and Medical Research Council (NHMRC)
Country [1] 265021 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 264116 0
Other
Name [1] 264116 0
Nganampa Council
Address [1] 264116 0
3 Wilkinson Street,
PO Box 2232, Alice Springs, NT, 0871
Country [1] 264116 0
Australia
Secondary sponsor category [2] 264123 0
Other
Name [2] 264123 0
Maari Ma Council
Address [2] 264123 0
443 Argent Street Broken Hill NSW 2880.
Country [2] 264123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267002 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 267002 0
North Terrace
Adelaide, SA 5005
Ethics committee country [1] 267002 0
Australia
Date submitted for ethics approval [1] 267002 0
01/02/2011
Approval date [1] 267002 0
21/02/2011
Ethics approval number [1] 267002 0
H-018-2011

Summary
Brief summary
The study aims to address the lack of high level evidence to support the use of silver fluoride application as an accepted community treatment intervention for deciduous dental caries.
Hypotheses:
That silver fluoride and atraumatic restorative treatment (ART) are equally effectively in successfully managing untreated cavitated dental caries in the primary dentition.
That silver fluoride has an additional benefit of reducing future development of new dental caries relative to ART.
Aim:
1. To evaluate the effectiveness of silver fluoride applications in minimizing negative sequelae of dental caries in young children compared with ART.
2. To evaluate the preventive effect on the development of new carious lesions of silver fluoride compared with ART.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32575 0
Prof Kaye Roberts-Thomson
Address 32575 0
Australian Research Centre for Population Oral Health,
The University of Adelaide, SA 5005
Country 32575 0
Australia
Phone 32575 0
+61 8 8313 4454
Fax 32575 0
Email 32575 0
[email protected]
Contact person for public queries
Name 15822 0
Prof Professor Kaye Roberts-Thomson
Address 15822 0
Australian Research Centre for Population Oral Health,
The University of Adelaide, SA 5005
Country 15822 0
Australia
Phone 15822 0
+61 8 8313 4454
Fax 15822 0
+61 8 8313 3070
Email 15822 0
[email protected]
Contact person for scientific queries
Name 6750 0
Prof Professor Kaye Roberts-Thomson
Address 6750 0
Australian Research Centre for Population Oral Health,
The University of Adelaide, SA 5005
Country 6750 0
Australia
Phone 6750 0
+61 8 8313 4454
Fax 6750 0
+61 8 8313 3070
Email 6750 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.