Microcrystalline hydroxyapatite is not inferior to fluorides in clinical caries prevention: a randomized, double-blind, non-inferiority trial

摘要: Recent evidence for a significant interference of microcrystalline hydroxapatite (HAP) particles with re- and demineralisation processes at the tooth-biofilm interface suggested, that they may be promising candidates efficacious caries prevention. This multicenter randomized controlled non-inferiority trial evaluated impact 2 x daily use HAP dentifrice without fluoride on progression enamel in adolescent caries-risk patients subjected to orthodontic therapy, fluoridated AmF/SnF serving as positive control. Primary study outcome was occurrence lesions ≥ ICDAS (International Caries Detection Assessment System) code 1 around brackets vestibular surfaces teeth 15-25 within 168 days observation period. Secondary outcomes were lesion 2, Plaque Index (PlI) Gingival (GI). Out 150 recruited patients, 147 included intent treat analysis (ITT); 133 finished per protocol (PP). PP data revealed 54.7% group compared 60.9% In ITT corresponding numbers 56.8% 61.6% (control). Non-inferiority testing well set proved preventive efficacy not inferior protection provided by Regarding all assessed secondary (enamel GI, PlI) no differences between both experimental groups observed. Within restraints design population this ingredient toothpaste thus regarded supplement fluorides clinical Clinical Trial registration ID #NCT02705456.