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Sealants for smooth surface caries prevention in children

Sealants for smooth surface caries prevention in children

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001240932
Enrollment
400
Registered
2011-12-05
Start date
2012-01-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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)

Sponsors

School of Dentistry, University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years
Healthy volunteers
Yes

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026