Oral Health Prev Dent. 2021 Dec 8;19:647-658. doi: 10.3290/j.ohpd.b2403649.
Hypersensitivity is a frequent complaint in children with molar incisor hypomineralisation (MIH). This double-blind randomised controlled trial aimed to evaluate non-inferiority in hypersensitivity relief of a toothpaste containing microcrystalline hydroxyapatite compared to amine fluoride in children with MIH.
Children were randomised into 2 groups: either hydroxyapatite (intervention) or amine fluoride toothpaste (control). The primary endpoint was pain sensation in response to tactile stimulus (Wong-Baker FACES Pain Rating Scale) 56 days after randomisation and analysed by mixed effects linear regression analysis. Non-inferiority was inferred if the upper limit of the one-sided 95% confidence interval (CI) of the difference between intervention and control group was below the non-inferiority margin of 1 in the ITT (intention-to-treat) and PP (per protocol) population.
Twenty-one children were randomised and 14 children finished the study per protocol. In the ITT population, hydroxyapatite was non-inferior to amine fluoride (mean difference: -0.75 95%CI [-∞;0.49]). In the PP population, non-inferiority could not be shown (-0.62 [-∞;1.08]).
Overall non-inferiority in hypersensitivity relief of a toothpaste containing hydroxyapatite compared to amine fluoride could not be shown. However, the hydroxyapatite group tended to be less hypersensitive in both populations. Attrition of the PP population due to the COVID-19 pandemic led to loss of statistical power.
在患有磨牙切牙牙釉质发育不全（MIH）的儿童中，过敏是常见的主诉。本双盲随机对照试验旨在评估含有微晶羟磷灰石的牙膏在缓解 MIH 儿童过敏方面相对于胺氟化物的非劣效性。
儿童随机分为 2 组：羟磷灰石（干预组）或胺氟化物牙膏（对照组）。主要终点是随机分组后 56 天对触觉刺激的疼痛感知（Wong-Baker FACES 疼痛评分量表），并通过混合效应线性回归分析进行分析。如果意向治疗（ITT）和符合方案（PP）人群中干预组和对照组之间差异的单侧 95%置信区间（CI）上限低于非劣效性边界 1，则推断非劣效性。
21 名儿童被随机分组，14 名儿童按方案完成研究。在 ITT 人群中，羟磷灰石与胺氟化物非劣效（平均差异：-0.75 95%CI [-∞；0.49]）。在 PP 人群中，无法显示非劣效性（-0.62 [-∞；1.08]）。
总体而言，与胺氟化物相比，含有羟磷灰石的牙膏在缓解过敏方面的非劣效性无法得到证明。然而，在两个人群中，羟磷灰石组的过敏倾向较低。由于 COVID-19 大流行，PP 人群的脱落导致统计效力丧失。
