Efficacy of HAF toothpastes in primary and permanent dentitions. A 2-years triple-blind RCT.

Objectives: The aim of this RCT was to compare the caries preventive efficacy and the slowing down of previous caries lesions of toothpastes containing fluoride biomimetic hydroxyapatite (HA) complex compared to sodium monofluorophosphate fluoridated toothpastes in Italian schoolchildren. To validate this hypothesis a triple-blind randomized clinical trial was designed.

Methods: In total 610 children (4-5 and 6-7 years) were enrolled. Four toothpastes, two containing fluoride-substituted hydroxyapatite (HAF) (1000 and 1450 ppmF) and magnesium-, strontium-, carbonate-substituted hydroxyapatite, in a chitosan matrix and two Mono fluoridated toothpastes (1000 and 1450 ppmF) were randomly administered during 24 months to two groups with younger children (G) and to two groups with older children (G), those containing 1450 ppmF. ICDAS was used to score lesions as initial (up to score 2), moderate (scores 3-4) and severe (scores 5-6). The children were instructed to brush for two minutes three times/day. Caries examination was repeated at 12 and 24 months. The efficacy of the treatment was assessed by calculating the reduction in Risk Ratio (RR) and the number needed to treat (NNT). Results; Overall, 518 patients (G = 268; G = 250) concluded the trial. The drop-rate was 11.84% for G and 17.22% for G. The caries increment at 24-month evaluation was statistically lower in the primary dentition in the HAF arms compared to the traditional fluoridated arms (0.18 vs 0.27 p = 0.04 in G and 0.16 vs 0.30 p = 0.01 in G for severe lesions). In the permanent dentition (G), caries increase was also statistically lower in the HAF arm, both for initial and severe lesions (0.09 vs 0.17 p = 0.02 and 0.18 vs 0.28 p = 0.01, respectively). In primary dentition, children receiving HAF Toothpaste had a RR of 39% (G) and 38% (G), compared to children receiving traditional Toothpastes. The RR in the permanent dentition was 29% in children treated with HAF toothpaste. Conclusions; The use of toothpastes containing biomimetic hydroxyapatite and fluoride reduces caries increment in children over a period of 2 years more than traditional fluoridated toothpastes.