Bock Niko C, Seibold Laura, Heumann Christian, Gnandt Erhard, Röder Miriam, Ruf Sabine
Department of Orthodontics, University of Giessen.
Private Practice, Hadamar.
Eur J Orthod. 2017 Apr 1;39(2):144-152. doi: 10.1093/ejo/cjw061.
White spot lesions (WSL) frequently occur as side-effect of multibracket appliance treatment. The clinical effects of local fluoridation on post-orthodontic WSL and oral health development are however inconclusive.
In vivo monitoring of clinical WSL and oral health changes in response to weekly 1.25 per cent fluoride gel application after multibracket appliance treatment.
Randomized, single-centre, double-blind, parallel-group, placebo-controlled study.
Patients with not less than 1 WSL (modified score 1 or 2) on not less than 1 upper front teeth after debonding.
Professional fluoride/placebo gel application during weeks 1-2; self-administered home application (weeks 3-24).
Clinical evaluation of WSL index, lesion activity, plaque index, gingival bleeding index, and decayed, missing, and filled teeth index as well as saliva buffer capacity and stimulated salivary flow rate (T0-T5).
Random assignment to test (n = 23) or placebo group (n = 23) using a sequentially numbered list (random allocation sequence generated for 50 subjects in 25 blocks of 2 subjects each).
The clinical study duration lasted from March 2011 to September 2013.
Unblinding was performed after complete data evaluation.
Intention-to-treat analysis set comprised 39 participants (test: n = 21, placebo: n = 18).
No clinical parameter except stimulated salivary flow rate (fluoride group: 1.1ml/min, placebo group: 0.74ml/min; P = 0.022) showed a statistically significant group difference after 24 weeks.
Several adverse events occurred similarly frequent in both groups; none was classified as possibly related to the study product.
The number of dropouts was higher than expected and the socio-economic status was not assessed. Furthermore, the unknown level of compliance during the home application phase must be considered as limitation.
Based on the results of this study, no clinical effect of post-orthodontic high-dose fluoride treatment on WSL and oral health changes could be detected.
The study was registered with ClinicalTrials.gov (Identifier: NCT01329731).
The protocol wasn't published before trial commencement.
白斑病变（WSL）常作为多托槽矫治器治疗的副作用出现。然而，局部用氟对正畸后WSL及口腔健康发育的临床效果尚无定论。
在多托槽矫治器治疗后，对每周应用1.25%氟化凝胶时临床WSL及口腔健康变化进行体内监测。
随机、单中心、双盲、平行组、安慰剂对照研究。
去除矫治器后上颌至少1颗前牙有不少于1个WSL（改良评分1或2）的患者。
第1 - 2周专业应用氟化物/安慰剂凝胶；第3 - 24周自行在家应用。
WSL指数、病变活性、菌斑指数、牙龈出血指数、龋失补牙指数的临床评估，以及唾液缓冲能力和刺激唾液流速（T0 - T5）。
使用连续编号列表随机分配至试验组（n = 23）或安慰剂组（n = 23）（为50名受试者生成随机分配序列，分为25个区组，每组2名受试者）。
临床研究持续时间为2011年3月至2013年9月。
在完整数据评估后解除设盲。
意向性分析集包括39名参与者（试验组：n = 21，安慰剂组：n = 18）。
24周后，除刺激唾液流速外（氟化物组：1.1ml/min，安慰剂组：0.74ml/min；P = 0.022），无临床参数显示组间有统计学显著差异。
两组中几种不良事件发生频率相似；均未归类为可能与研究产品有关。
失访人数高于预期，且未评估社会经济状况。此外，家庭应用阶段未知的依从性水平必须视为局限性。
基于本研究结果，未检测到正畸后高剂量氟治疗对WSL及口腔健康变化有临床效果。
该研究已在ClinicalTrials.gov注册（标识符：NCT01329731）。
研究方案在试验开始前未发表。
