Department of Orthodontics, Faculty of Odontology, Malmö University.
Bernhold Ortodonti, Private Practice, Helsingborg, Sweden.
Eur J Orthod. 2020 Jun 23;42(3):326-330. doi: 10.1093/ejo/cjz045.
Self-applied and professional fluorides are key elements to limit caries-related side-effects during orthodontic treatment with fixed appliances.
To evaluate the effectiveness of a new fluoride varnish formula containing 1.5% ammonium fluoride in preventing white spot lesions (WSLs) in adolescents undergoing multi-bracket orthodontic treatment.
The study employed a randomized controlled triple-blinded design with two parallel arms. One hundred eighty-two healthy adolescents (12-18 years) referred to three orthodontic specialist clinics were eligible and consecutively enrolled. Informed consent was obtained from 166 patients and they were randomly allocated to a test or a placebo group (with aid of a computer program, generating sequence numbers in blocks of 15). In the test group, fluoride varnish was applied in a thin layer around the bracket base every sixth week during the orthodontic treatment, while patients in the placebo group received a varnish without fluoride. The intervention started at onset of the fixed appliances and continued until debonding. The endpoint was prevalence and severity of WSLs on the labial surfaces of the maxillary incisors, canines, and premolars as scored from high-resolution pre- and post-treatment digital photos with aid of a four-level score.
One hundred forty-eight patients completed the trial, 75 in the test group and 73 in the placebo group (dropout rate 10.8%). The total prevalence of WSL's on subject level after debonding was 41.8% in the test group and 43.8% in the placebo group. The number of patients exhibiting more severe lesions (score 3 + 4) was higher in the placebo group (P < 0.05); the absolute risk reduction was 14% and the number needed to treat was 7.1.
The multicentre design with somewhat diverging routines at the different clinics may have increased risk for performance bias. No health-economic evaluation was carried out.
Regular applications of an ammonium fluoride varnish reduced the prevalence of advanced WSL during treatment with fixed orthodontic appliances.
ClinicalTrials.gov (NCT03725020).
The protocol was not published before trial commencement.
自我应用和专业应用的氟化物是限制固定矫治器正畸治疗相关副作用的关键因素。
评估一种含有 1.5% 氟化铵的新型氟化物漆配方在预防多托槽正畸治疗青少年患者的白斑病（WSL）方面的有效性。
本研究采用随机对照三盲设计，分为两个平行组。共有 182 名健康青少年（12-18 岁）被纳入 3 家正畸专科诊所，他们符合条件并连续入选。在 166 名患者中获得了知情同意，并通过计算机程序将他们随机分配到实验组或安慰剂组（采用 15 个为一组的随机数字序列）。实验组每 6 周在托槽底座周围涂一层薄薄的氟化物漆，而安慰剂组患者则涂一层不含氟化物的漆。干预措施从固定矫治器开始，一直持续到拆除。终点是使用高分辨率的治疗前后数码照片，根据四级评分，评估上颌切牙、尖牙和前磨牙唇面的 WSL 患病率和严重程度。
148 名患者完成了试验，实验组 75 名，安慰剂组 73 名（失访率 10.8%）。拆除固定器后，在患者水平上 WSL 的总患病率为实验组 41.8%，安慰剂组 43.8%。在安慰剂组中，出现更严重病变（评分 3+4）的患者人数更高（P<0.05）；绝对风险降低 14%，需要治疗的人数为 7.1。
由于不同诊所的操作流程略有不同，多中心设计可能会增加操作偏倚的风险。未进行健康经济学评价。
固定正畸矫治器治疗期间，定期应用氟化铵漆可降低 WSL 的发生率。
ClinicalTrials.gov（NCT03725020）。
试验开始前未发表方案。
