Glass-ionomer-based materials for preventing carious lesions in Chinese children

The study inclusion criteria consist of molar teeth in the mandible that are at high risk for developing carious lesions in pits and fissures of occlusal and buccal tooth surfaces of young children. The number of children included in the study have been determined through power calculations and randomly divided over 3 parallel groups: a resin, a high-viscosity glass-ionomer and a glass-carbomer sealant group. The different sealant materials have been applied using the manufacturers’ Direction for Use.

Sealants will be periodically (0.5, 1, 2, 3, 4 and 5 years) evaluated by independent and calibrated evaluators using the ART criteria.
The wear pattern over time will be assessed from replicas produced from impressions taken at each of the 6 evaluation times. The measurements will include loss of volume and height obtained through using 3-D laser images and relevant computer software. Survival analysis and parametric tests will be applied to assess the type of sealant that prevents carious lesion development in pits and fissures of these children best. Cost data have been collected using activity sampling procedure.

There is no difference in carious lesion development between sealants of glass-ionomer, glass-carbomer and composite resin and placed in first permanent molars after 5 years

Clinical evaluation after 6 months, 1, 2, 3, 4, and 5 years.

Each time of evaluation an impression of a sample of sealed teeth by group will be taken.

Four sealant groups.

1. Composite resin = positive control

2. Glass-ionomer, improved version = experimental

3. Glass-ionomer plus light-curing = experimental

4. Glass-carbomer, new material = experimental

First permanent molars will be sealed.