High‐fluoride toothpaste: a multicenter randomized controlled trial in adults

Objective The aim of this single – blind, multicenter, parallel, randomized controlled trial was to evaluate the effectiveness of the application of a high‐fluoride toothpaste on root caries in adults. Methods Adult patients ( n  = 130, ♂ = 74, ♀ = 56; mean age ± SD : 56.9 ± 12.9) from three participating centers, diagnosed with root caries, were randomly allocated into two groups: Test ( n  = 64, ♂ = 37, ♀ = 27; lesions = 144; mean age: 59.0 ± 12.1; intervention: high‐fluoride toothpaste with 5000 ppm F ), and Control ( n  = 66, ♂ = 37, ♀ = 29; lesions = 160; mean age: 54.8 ± 13.5; intervention: regular‐fluoride toothpaste with 1350 ppm F ) groups. Clinical examinations and surface hardness scoring of the carious lesions were performed for each subject at specified time intervals ( T 0 – at baseline before intervention, T 1 – at 3 months and T 2 – at 6 months after intervention). Mean surface hardness scores ( HS ) were calculated for each patient. Statistical analyses comprised of two‐way analysis of variance and post hoc comparisons using the B onferroni– D unn correction. Results At T 0 , there was no statistical difference between the two groups with regard to gender ( P  =   0.0682, unpaired t ‐test), or age ( P  =   0.9786, chi‐squared test), and for the overall HS (Test group: HS  = 3.4 ± 0.61; Control group: HS  = 3.4 ± 0.66; P  =   0.8757, unpaired t ‐test). The anova revealed significantly better HS for the test group than for the control groups ( T 1 : Test group: HS  = 2.9 ± 0.67; Control group: HS  = 3.1 ± 0.75; T 2 : T est group: HS  = 2.4 ± 0.81; Control group: HS  = 2.8 ± 0.79; P  < 0.0001). However, the interaction term time‐point*group was not significant. Conclusions The application of a high‐fluoride containing dentifrice (5000 ppm F ) in adults, twice daily, significantly improves the surface hardness of otherwise untreated root caries lesions when compared with the use of regular fluoride containing (1350 ppm F ) toothpastes.