Clinical trial evaluates enhanced fluoride varnish

Dental Tribune International

Mon. 18. May 2026

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HONG KONG, China: Functionalised tricalcium phosphate (fTCP) was developed to keep calcium and phosphate from reacting prematurely with fluoride in remineralising products during storage, allowing these ions to be released at the tooth surface after application. Previous research has suggested that fTCP-containing fluoride varnish can help arrest active caries, and a new randomised controlled clinical trial has examined whether the same approach could also help prevent caries. The findings suggest that fTCP-containing varnish can offer value for managing early childhood caries among high-risk children.

The researchers, from the University of Hong Kong, assessed whether a fluoride varnish containing fTCP could better prevent early childhood caries than conventional fluoride varnish in children with active caries. The double-blind trial recruited 3-year-olds with untreated active caries and followed them over a two-year period. The children were randomly assigned to receive either a standard 5% sodium fluoride varnish or a version containing fTCP. Before varnish application, all active carious lesions were treated with silver nitrate to promote caries arrest. This two-step protocol was applied every six months.

The researchers reported no significant differences between the two groups in overall caries outcomes at child level. Rates of new cavities and increases in decayed, missing or filled teeth were comparable between the treatments. Surface-level analysis showed that slightly fewer sound tooth surfaces developed caries in the fTCP group, particularly on mandibular posterior teeth. However, the difference was not statistically significant.

The authors thus concluded that the two varnishes offered equivalent preventive efficacy. However, they also suggested that the fTCP-containing varnish might not have outperformed the conventional one in this cohort because the children’s exposure to fluoridated water and fluoridated toothpaste may already have limited the scope for any additional remineralisation benefit.

The study also highlighted the persistence of disease risk in this population. More than four in five children developed at least one new cavitated lesion during follow-up despite twice-yearly fluoride applications, reinforcing the need to combine varnish application with broader caries-prevention measures for children with high caries risk.

The researchers said that the findings support the use of either varnish formulation in kindergarten-based prevention programmes. They emphasised, however, that the fTCP-containing product holds dual clinical value because previous work using the same treatment protocol showed improved arrest of cavitated lesions.

The study, titled “Use of fluoride varnish with functionalized tricalcium phosphate for prevention of early childhood caries: A randomised clinical trial”, was published in the April 2026 issue of Dental Research.