Impact of a toothpaste with microcrystalline hydroxyapatite on the occurrence of early childhood caries: a 1-year randomized clinical trial

Abstract

The aim of this trial was to determine whether a toothpaste with microcrystalline hydroxyapatite is not inferior to a fluoride toothpaste in prevention of caries in children. This double-blinded randomized control trial compared two toothpastes regarding the occurrence of caries lesions using International Caries Detection and Assessment System (ICDAS) ≥ code 1 on the primary dentition within 336 days. The test group used a fluoride-free hydroxyapatite toothpaste three times daily while control group used a toothpaste with fluoride. 207 children were included in the intention-to-treat analysis; 177 of them finished the study per protocol. An increase in caries ICDAS ≥ code 1 per tooth was observed in 72.7% of the hydroxyapatite-group (n = 88), compared with 74.2% of the fluoride-group (n = 89). The exact one-sided upper 95% confidence limit for the difference in proportion of participants with ICDAS increase ≥ 1 (-1.4%) was 9.8%, which is below the non-inferiority margin of 20% demonstrating non-inferiority of hydroxyapatite compared to the fluoride control toothpaste. This RCT showed for the first time, that in children, the impact of the daily use of a toothpaste with microcrystalline hydroxyapatite on enamel caries progression in the primary dentition is not inferior to a fluoride control toothpaste (Clinical Trials NCT03553966).

Signaling Pathway and Transcriptional Regulation in Osteoblasts during Bone Healing: Direct Involvement of Hydroxyapatite as a Biomaterial

“…However, Chandran et al (2016) showed that the administration of microHA in osteoporotic rats did not provide a higher regeneration efficiency than the sham group [48]. This is also in line with clinical findings [49][50][51]. RCT by Schlagenhauf et al (2019) showed that daily use of microHA dentifrice on caries progression was not significantly different from 1400 ppm fluoride toothpaste [49].…”

The Potential of Hydroxyapatite Toothpaste to Prevent Root Caries: A pH-Cycling Study

“…Previous clinical, in situ and in vitro studies have established hydroxyapatite crystals in toothpaste and mouthrinse to be as effective as fluoride in reducing tooth demineralization as well as promoting caries remineralization. 28,31,33,39,40 For this reason, the present study investigated and compared the effectiveness of a HAP-based toothpaste with that of a standard non-prescription toothpaste containing 1450 ppm fluoride (NaF) in preventing root dentin demineralization (root caries). The daily use of the toothpaste was simulated using a netdemineralization pH-cycling caries model (caries prevention or anticaries model).…”

“…This observation confirmed the reports of previous studies in which the non-inferiority of HAP to fluoride in prevention and remineralization of enamel caries was demonstrated in three clinical studies and a similar pH cycling study. 28,31,32,39 Two randomized controlled trial demonstrated the non-inferiority of 10% HAP toothpaste to 1400 ppm and 500 ppm fluoride toothpaste respectively, 28,39 while an in situ study reported non-inferiority of 10% HAP toothpaste to 500 ppm fluoride toothpaste. 31 The pH cycling study showed the non-inferiority of 15% HAP oral care gel to 12,500 ppm fluoride gel.…”

“…40,43 The observed 21% inhibition of demineralization by HAP in the present study is in agreement with previous studies that demonstrated the effectiveness of toothpaste containing varying percentages of HAP in inhibiting tooth tissue demineralization. 27,28,31,39,40 This effect of HAP has been attributed to several characteristics of the synthetic particulate HAP, which determines its mode of actions. Synthetic HAP in nanocrystalline or microcluster forms shows a high similarity to the mineral phase of human teeth, and it is bioactive and biocompatible with a strong affinity to tooth tissues.…”

Hydroxyapatite in Oral Care Products—A Review

“…The ideal properties of a dentifrice include minimal abrasive effect, non-irritating, non-toxic, non-staining, protects against caries and biofilm formation, while being costeffective and readily available [21]. Many studies have been conducted to test the efficacy of HA, especially in enamel and dentine remineralisation, biofilm control, reducing dentine sensitivity, and tooth whitening [5,10,11,[22][23][24][25][26][27][28][29][30]. Currently, only a few reviews report on nanomaterial in oral care products or HA in dentistry which includes restorative, preventative, and regenerative applications [5,10,11,31,32].…”