Department of Integrated Dentistry, Poznan University of Medical Sciences, Poznan, Poland.
Department of Integrated Dentistry, Medical University of Bialystok, Bialystok, Poland.
Front Public Health. 2023 Jul 18;11:1199728. doi: 10.3389/fpubh.2023.1199728. eCollection 2023.
Dental caries is a worldwide challenge for public health. The aim of this 18-month double-blinded, randomized, clinical trial was to compare the caries-preventing effect of a fluoride-free, hydroxyapatite toothpaste (test) and a toothpaste with sodium fluoride (1450 ppm fluoride; positive control) in adults.
The primary endpoint was the percentage of subjects showing no increase in overall Decayed Missing Filled Surfaces (DMFS) index. The study was designed as non-inferiority trial. Non-inferiority was claimed if the upper limit of the exact one-sided 95% confidence interval for the difference of the primary endpoint DMFS between test and control toothpaste was less than the predefined margin of non-inferiority (Δ ≤ 20%).
In total, 189 adults were included in the intention-to-treat (ITT) analysis; 171 subjects finished the study per protocol (PP). According to the PP analysis, no increase in DMFS index was observed in 89.3% of subjects of the hydroxyapatite group and 87.4% of the subjects of the fluoride group. The hydroxyapatite toothpaste was not statistically inferior to a fluoride toothpaste with regard to the primary endpoint.
Hydroxyapatite was proven to be a safe and efficient anticaries agent in oral care.
NCT04756557.
龋齿是全球公共卫生面临的挑战。本为期 18 个月、双盲、随机、临床研究旨在比较无氟、羟基磷灰石牙膏（试验组）和含氟酸钠（1450ppm 氟化物；阳性对照组）对成人龋齿预防效果。
主要终点为未出现总体龋齿填补表面（DMFS）指数增加的受试者比例。本研究设计为非劣效性试验。如果试验组和对照组牙膏在主要终点 DMFS 差异的精确单侧 95%置信区间上限小于预定非劣效性边界（Δ≤20%），则认为具有非劣效性。
共有 189 名成年人纳入意向治疗（ITT）分析；171 名受试者按方案（PP）完成研究。根据 PP 分析，在羟基磷灰石组 89.3%的受试者和氟化物组 87.4%的受试者中，DMFS 指数未增加。羟基磷灰石牙膏在主要终点方面与含氟牙膏无统计学差异。
羟基磷灰石在口腔护理中被证明是一种安全有效的抗龋齿剂。
NCT04756557。
