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Trial registered on ANZCTR


Registration number
ACTRN12611000827932
Ethics application status
Approved
Date submitted
4/08/2011
Date registered
5/08/2011
Date last updated
19/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevention of early decay in children’s teeth
Scientific title
Resin infiltration of proximal carious lesions in the primary dentition of Otago children for lesion progression reduction
Secondary ID [1] 262779 0
Nil
Universal Trial Number (UTN)
U1111-1123-4541
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral health 270487 0
Caries 270488 0
Condition category
Condition code
Oral and Gastrointestinal 270644 270644 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 270645 270645 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Caries infiltration using resin. Dose as described by ICON. This involves two administrations of approximately 7 mls each time to the lesion (the first for 3 minutes and the second for 1 minute). This will only occur once over the study and in total time will take 10 minutes.
Intervention code [1] 269119 0
Prevention
Intervention code [2] 269128 0
Treatment: Other
Intervention code [3] 269129 0
Early detection / Screening
Comparator / control treatment
Fluoride (Durahat) varnish standard treatment
Control group
Active

Outcomes
Primary outcome [1] 269369 0
30 % reduction in caries progression using digital radiography
Timepoint [1] 269369 0
6 months, 1 year, 18months, 2 years to tooth exfoliates
Secondary outcome [1] 279464 0
Reduced dental anxiety over time using the Modified Corah Dental Anxiety Scale
Timepoint [1] 279464 0
2 years
Secondary outcome [2] 279465 0
Patency of seal of caries lesion using Scanning Electron Microscopy and Micro-CT.
Timepoint [2] 279465 0
Once tooth exfoliated

Eligibility
Key inclusion criteria
Inclusion criteria for the children to take part in the study will be the presence of at least 2 proximal lesions in enamel or outer dentine in deciduous molar teeth, as detected radiographically. Lesions on the mesial of the first molars will not be included as the contact area to the canines is too narrow.
Minimum age
6 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be medically compromised children.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
1/06/2013
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
120
Accrual to date
Final
122
Recruitment outside Australia
Country [1] 3768 0
New Zealand
State/province [1] 3768 0
Otago

Funding & Sponsors
Funding source category [1] 269600 0
Commercial sector/Industry
Name [1] 269600 0
DMG
Country [1] 269600 0
Germany
Primary sponsor type
University
Name
University of Otago
Address
POBox 647
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 266634 0
Individual
Name [1] 266634 0
D Schwass
Address [1] 266634 0
POBox 647
Dunedin 9054
Country [1] 266634 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269552 0
Lowe South Ethics Committee
Ethics committee address [1] 269552 0
Ethics committee country [1] 269552 0
New Zealand
Date submitted for ethics approval [1] 269552 0
27/07/2011
Approval date [1] 269552 0
20/08/2011
Ethics approval number [1] 269552 0
URA/11/08/037

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32976 0
Dr Lyndie Foster Page
Address 32976 0
University of Otago
PO Box 647
Dunedin 9054
New Zealand
Country 32976 0
New Zealand
Phone 32976 0
+6434795853
Fax 32976 0
Email 32976 0
lyndie.fosterpage@otago.ac.nz
Contact person for public queries
Name 16223 0
Dr L A Foster Page
Address 16223 0
Department of Rehabilitation
University of Otago
PO Box 647
Dunedin 9054
Country 16223 0
New Zealand
Phone 16223 0
6434795853
Fax 16223 0
Email 16223 0
lyndie.fosterpage@otago.ac.nz
Contact person for scientific queries
Name 7151 0
Dr L A Foster Page
Address 7151 0
Department of Rehabilitation
University of Otago
PO Box 647
Dunedin 9054
Country 7151 0
New Zealand
Phone 7151 0
6434795853
Fax 7151 0
Email 7151 0
lyndie.fosterpage@otago.ac.nz

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.