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Schlagenhauf, Ulrich, Kunzelmann, Karl-Heinz, Hannig, Christian, May, Theodor W., Hoesl, Helmut, Gratza, Mario, Viergutz, Gabriele, Nazet, Marco, Schamberger, Sebastian and Proff, Peter (2019): Impact of a non-fluoridated microcrystalline hydroxyapatite dentifrice on enamel caries progression in highly caries-susceptible orthodontic patients: A randomized, controlled 6-month trial. In: Journal of Investigative and Clinical Dentistry, Vol. 10, No. 2, e12399

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AimThe aim of the present randomized, controlled trial was to compare the impact of the regular use of a fluoride-free microcrystalline hydroxyapatite (HAP) dentifrice and a 1400ppm fluoride control dentifrice on caries progression in 150 highly caries-active orthodontic patients. MethodsThe primary outcome was the occurrence of lesions with International Caries Detection and Assessment System (ICDAS) code 1 on the vestibular surfaces of teeth 15-25 within 168days after fixation of orthodontic brackets. Secondary outcomes were lesion development ICDAS code 2, the plaque index, and the gingival index. ResultsIn total, 147 patients were included in the intent-to-treat (ITT) analysis;133 finished the study per protocol (PP). An increase in enamel caries ICDAS code 1 was observed in 56.8% (ITT) and 54.7% (PP) of the HAP group participants compared with 60.9% (ITT) and 61.6% (PP) of the fluoride control group. Non-inferiority testing (ITT and PP) demonstrated the absence of a significant difference between the groups. No significant differences in secondary outcomes were observed between the groups. ConclusionIn highly caries-active patients, the impact of the regular use of a microcrystalline HAP dentifrice on caries progression is not significantly different from the use of a 1400ppm fluoride toothpaste (ClinicalTrials.gov: NCT02705456).

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