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
Traditional approaches for preventing proximal lesions such as flossing and rinsing with fluoride usually have limited success as they rely heavily on patients’ compliance (Alm et al. 2007). More recently, treatment of proximal caries has been focussed on arresting initial caries by sealing these lesions with low viscosity resins (Ekstrand et al. 2010). Although early success has been reported using this technique, there is a need to gain access to the proximal lesions which requires physical separation of the teeth. As this technique usually involves two appointments, it is not practical for young children.

A more conservative alternative would be to seal the teeth while it is possible to gain access to the proximal smooth surfaces before the contacts with adjacent teeth are established. There are a few stages in the development of the primary and permanent dentitions which provide windows of opportunity to gain such access to specific proximal surfaces of the posterior teeth.

HYPOTHESIS
We hypothesize that smooth surface sealants (SSS) placed prior to establishment of the proximal contacts can prevent proximal caries in teeth.

AIMS
Therefore the aims of the study are to:
(1) Determine the caries incidence in sealed surfaces of primary and secondary teeth compared to unsealed surfaces in the same teeth in other quadrants of the mouth.

(2) Evaluate the cost effectiveness of smooth surface sealants in preventing caries
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.