Introduction/objectives: The review systematically explored in vivo or in situ studies investigating the efficacy of nano-hydroxyapatite (nHA) to reduce initiation of or to remineralize initial caries lesions.
Data: Prospective controlled (non-)randomized clinical trials investigating the efficacy of a nHA compared to any other (placebo) treatment or untreated/standard control.
Sources: Three electronic databases (Central Cochrane, PubMed-MEDLINE, Ovid EMBASE) were screened. Outcomes were, e.g., ICDAS score, laser fluorescence, enamel remineralization rate, mineral loss, and lesion depth. No language or time restrictions were applied. Risk of bias and level of evidence were graded using the Risk of Bias 2.0 tool and GRADE profiler.
Study selection/results: Five in vivo (and 5 in situ) studies with at least 633 teeth (1031 specimens) being assessed in more than 420 (95) patients were included. No meta-analysis could be performed for in vivo studies due to the high heterogeneity of the study designs and the variety of outcomes. In situ studies indicate that under demineralization conditions, NaF was able to hinder demineralization, whereas nHA did not; simultaneously, nHA did not differ from the fluoride-free control. In contrast, under remineralizing conditions, nHA and NaF show the same remineralizing potential. However, the level of evidence was very low. Furthermore, six studies showed a high risk of bias, and six studies were funded/published by the manufacturers of the tested products.
Conclusion: The low number of clinical studies, the relatively short follow-up periods, the high risks of bias, and the limiting grade of evidence do not allow for conclusive evidence on the efficacy of nHA.
Clinical relevance: No conclusive evidence on the efficacy of nHA could be obtained based on the low number of clinical studies, the relatively short follow-up periods, the high risks of bias, the limiting grade of evidence, and study conditions that do not reflect the everyday conditions.
