Department of Orthodontics, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Am J Orthod Dentofacial Orthop. 2022 Jul;162(1):6-15.e3. doi: 10.1016/j.ajodo.2022.03.011. Epub 2022 Apr 28.
The objective was to evaluate the effect of a fluoride mouth rinse and a high-fluoride toothpaste on caries incidence in patients undergoing orthodontic treatment with fixed appliances.
In this 3-armed, parallel-group, randomized controlled trial, patients referred to the Specialist Clinic of Orthodontics, Mölndal, Sweden, were randomly allocated to 1 of the 3 groups. (1) Fluoride mouth rinse (FMR) group: 0.2 % sodium fluoride (NaF) mouth rinse plus 1450 ppm fluoride (F) toothpaste; (2) High-fluoride tootpaste (HFT) group: 5000 ppm F toothpaste; and (3) Control (CTR) group: 1450 ppm F toothpaste. The generation of a randomization sequence was performed in blocks of 30. Inclusion criteria included patients scheduled for treatment with fixed appliances in the maxillary and mandibular arch aged 12-20 years. The primary outcome variable was the change in Decayed Initial Filled Surfaces (ΔDiFS) based on radiographs taken before and after the treatment. For statistical comparisons between groups, the Kruskal-Wallis test were used for continuous variables, whereas the Mann-Whitney U-test was used for pairwise group comparisons. Furthermore, the risk ratio (RR) and 95% confidence interval (CI) based on clinically relevant cutoffs (DiFS ≥2) were calculated to compare the increase of caries during orthodontic treatment between 2 groups. The Cochran-Mantel-Haenszel method was used to adjust RR for baseline values. Blinding was employed during the caries registration and the data analysis.
In total, 270 participants were randomized, with 15 patients dropping out, such that 255 patients were included in the statistical analyses. Recruitment was from October 2010 to December 2012. An increase in DiFS (≥1 DiFS) during treatment was observed in 48.3% of the FMR group, 42.0% of the HFT group, and 35.6% of the CTR group. There was no significant difference between the groups regarding increased DiFS (P = 0.17). The risk of increase in DiFS ≥2 during orthodontic treatment was 31.0% in the FMR group, 25.9% in the HFT group, and 18.4% in the CTR group. The RR for an increase of ≥2 DiFS during orthodontic treatment was 1.38 (95% CI, 0.81-2.34; P = 0.23) for FMR vs CTR, 1.21 (95% CI, 0.70-2.10; P = 0.51) for HFT vs CTR, and 0.93 (95% CI, 0.57-1.49; P = 0.76) for HFT vs FMR.
In patients who demonstrate a low prevalence of caries and are undergoing orthodontic treatment, daily use of high-fluoride toothpaste or fluoride mouth rinse in combination with regular toothpaste does not appear to significantly alter the caries incidence compared with the use of regular toothpaste.
The trial was registered in the FoU i Sverige research database (http://www.fou.nu/is/sverige), with registration no. 236251.
The protocol was not published before trial commencement.
Local Research and Development Board for Gothenburg and South Bohuslän (grant no. 768531); and The Swedish Patent Revenue Fund (grant number EKF-780/19).
本研究旨在评估含氟漱口水和高氟牙膏对接受固定正畸治疗的患者龋齿发病率的影响。
这是一项 3 臂平行组随机对照试验，在瑞典莫尔恩达尔正畸专家诊所就诊的患者被随机分配到 3 组中的 1 组。（1）氟化物漱口液（FMR）组：0.2%氟化钠（NaF）漱口液加 1450ppm 氟牙膏；（2）高氟牙膏（HFT）组：5000ppm F 牙膏；（3）对照组（CTR）：1450ppm F 牙膏。随机序列的生成采用 30 个块的分组方式。纳入标准包括年龄在 12-20 岁、计划在上颌和下颌弓中接受固定矫治器治疗的患者。主要结局变量是治疗前后 X 线片上的 Decayed Initial Filled Surfaces（ΔDiFS）变化。为了比较组间的统计学差异，连续变量采用 Kruskal-Wallis 检验，组间比较采用 Mann-Whitney U 检验。此外，根据临床相关临界值（DiFS≥2）计算龋齿在正畸治疗期间增加的风险比（RR）和 95%置信区间（CI），以比较两组之间在正畸治疗过程中龋齿的增加情况。采用 Cochran-Mantel-Haenszel 法校正基线值的 RR。在龋齿登记和数据分析过程中采用了盲法。
共随机分配了 270 名患者，15 名患者退出，因此有 255 名患者纳入统计分析。招募工作于 2010 年 10 月至 2012 年 12 月进行。在 FMR 组、HFT 组和 CTR 组中，分别有 48.3%、42.0%和 35.6%的患者在治疗过程中 DiFS 增加（≥1 DiFS）。组间 DiFS 增加无显著差异（P=0.17）。FMR 组、HFT 组和 CTR 组在正畸治疗期间 DiFS≥2 增加的风险分别为 31.0%、25.9%和 18.4%。FMR 与 CTR 相比，DiFS 增加≥2 的 RR 为 1.38（95%CI，0.81-2.34；P=0.23），HFT 与 CTR 相比，RR 为 1.21（95%CI，0.70-2.10；P=0.51），HFT 与 FMR 相比，RR 为 0.93（95%CI，0.57-1.49；P=0.76）。
在龋齿低患病率且正在接受正畸治疗的患者中，与使用常规牙膏相比，每日使用高氟牙膏或氟化物漱口水联合常规牙膏似乎不会显著改变龋齿发病率。
该试验在瑞典 FoU i Sverige 研究数据库（http://www.fou.nu/is/sverige）进行注册，注册号为 236251。
试验开始前未发布方案。
哥德堡和南博胡斯兰地方研发委员会（拨款号 768531）；以及瑞典专利收入基金（拨款号 EKF-780/19）。
