Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001240932
Ethics application status
Not yet submitted
Date submitted
9/03/2011
Date registered
5/12/2011
Date last updated
5/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Sealants for smooth surface caries prevention in children
Scientific title
Sealants for smooth surface caries prevention in children
Secondary ID [1] 259758 0
UQSPACE1 University of Queensland
Universal Trial Number (UTN)
U1111-1119-8464
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries on healthy children attending a governemnt dental clinic of Longan-Beaudesert Division of Metro South Queensland 261338 0
Condition category
Condition code
Oral and Gastrointestinal 259487 259487 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 smooth surface sealant on proximal and occlusal surface of first permanent and primary molars

The sealant to be used is a commercially available and TGA approved product named "G-Coat Plus" manufactured by GC, Tokyo, Japan

The sealant will be applied once at the start of the trial according to standard protocol for clinical application of sealant (eg: clean surface, apply G Coat Plus then set it with a light source)
Intervention code [1] 264183 0
Treatment: Other
Intervention code [2] 283848 0
Prevention
Comparator / control treatment
Routine treatment currently used in clinics, this include oral hygiene, diet counselling and topical fluoride treatment
Control group
Active

Outcomes
Primary outcome [1] 262296 0
prevention of lesion formation on treated surfaces this will be determined using radiographs which would be part of routine check up
Timepoint [1] 262296 0
Baseline, 6, 12, 24, 36 months
Secondary outcome [1] 273479 0
saliva profile ( the saliva profile will be measured using a Saliva Test Kit,manufactured by GC. Ask subject to spit a drop of saliva into a cup then measure its pH using a pH test strip, collect stimulated saliva by asking subject to chew on paraffin wax and spit in a cup, the volume is recorded and the buffering capacity is measured using a test trip manufactured by GC)
Timepoint [1] 273479 0
baseline, 12, 24, 36 ,months
Secondary outcome [2] 295115 0
oral hygiene to be assessed clincially, by obeservation and graded according to the amount of dental plaque found on tooth surfaces. this is performed by the reviewers.
Timepoint [2] 295115 0
baseline, 12, 24, 36 ,months

Eligibility
Key inclusion criteria
Group 1: intact and exposed caries-free and accessible surfaces in the primary second teeth
Group 2: Intact and exposed caries-free and accessible surfaces in the permanent teeth
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with
1/significant medical conditions that can affect dental treatment
2/Significant dental conditions associated with abnormalities of tooth structure and form
3/Preexisitng carious lesions on the test surfaces which have extended into dentino-enamel junctions as diagnosed from radiographs
4/congenitally absent adjacent permanent teeth to the surface to be sealed.

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)
Split mouth design with one side receiving intervention while the other side standard treatment. A toss of a coin will determine which side is control or test
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Toss of a coin.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264628 0
University
Name [1] 264628 0
School of Dentistry, University of Queensland
Country [1] 264628 0
Australia
Primary sponsor type
University
Name
School of Dentistry, University of Queensland
Address
University of Queensland
200 Turbot St
Brisbane QLD4000
Country
Australia
Secondary sponsor category [1] 263768 0
Commercial sector/Industry
Name [1] 263768 0
GC Australasia
Address [1] 263768 0
Level 4 Bayview Tower
1753 Botany Rd
Nalsmeadow NSW 2019
Country [1] 263768 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266632 0
Queensland Health Ethics Committee
Ethics committee address [1] 266632 0
Ethics committee country [1] 266632 0
Australia
Date submitted for ethics approval [1] 266632 0
15/04/2011
Approval date [1] 266632 0
14/10/2011
Ethics approval number [1] 266632 0
HREC/11/QPAH/364

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

Contacts
Principal investigator
Name 32322 0
Address 32322 0
Country 32322 0
Phone 32322 0
Fax 32322 0
Email 32322 0
Contact person for public queries
Name 15569 0
Professor Hien Ngo
Address 15569 0
School of Dentistry
Univ of Queensland
200 Turbot St, QLD 4000
Country 15569 0
Australia
Phone 15569 0
+61 451507145
Fax 15569 0
Email 15569 0
[email protected]; [email protected]
Contact person for scientific queries
Name 6497 0
Professor Hien Ngo
Address 6497 0
School of Dentistry
Univ of Queensland
200 Turbot St, QLD 4000
Country 6497 0
Australia
Phone 6497 0
+61 451507145
Fax 6497 0
Email 6497 0
[email protected]; [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.