Department of Orthodontics, Faculty of Odontology, Malmö University, Sweden.
Bernhold Ortodonti, Private Practice, Helsingborg, Sweden.
Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.
Topical fluorides are commonly recommended to prevent the development of white spot lesion (WSL) during treatment with fixed orthodontic appliances (FOAs), but the certainty of evidence is low, and long-term effects of fluoride preventive methods to reduce lesions seem to be rare.
To evaluate the long-term effectiveness of professional applications of a fluoride varnish containing 1.5% ammonium fluoride in preventing WSL development in adolescents undergoing multi-bracket orthodontic treatment.
We performed a randomized controlled trial in which 166 healthy adolescents (12-18 years) from three different clinics were enrolled and randomly allocated to a test or a placebo group. The randomization was performed by a computer program, generating sequence numbers in blocks of 15. The fluoride varnish or the non-fluoride placebo varnish was applied in a thin layer around the bracket base every sixth week during the course of the orthodontic treatment (mean duration 1.7 years). We scored the prevalence of WSL on the labial surfaces of the maxillary incisors, canines and premolars immediately after debonding (baseline) and approximately 1 year after debonding, from digital photos with aid of a four-step score. The examiners were not involved in the treatment of the patients and blinded for the group assignment.
One hundred and forty-eight patients were available at debonding and 142 of them could be re-examined after 1 year (71 in the test and 71 in the placebo group). The 1-year attrition rate was 4.0%. On patient level, the prevalence of post-orthodontic WSLs (score ≥ 2) dropped by over 50% during the follow-up with no significant difference between the groups. On surface level, there were significantly fewer remaining WSLs in the test group compared with the placebo group (4.5% versus 10.4%; relative risk 0.44, 95% confidence interval 0.28-0.68).
The compliance with fluoride toothpaste was not checked, and the patients' general dentists may have instigated additional risk-based preventive measures. No cost-benefit analysis was carried out.
This follow-up study displayed a small beneficial long-term effect of fluoride varnish in reducing WSL development during treatment with FOA.
NCT03725020.
The protocol was not published before trial commencement.
在固定正畸矫治器（FOA）治疗期间，常推荐局部使用氟化物来预防白斑病（WSL）的发生，但证据确定性低，并且氟化物预防方法减少病变的长期效果似乎很少见。
评估专业应用含 1.5% 氨氟化物氟漆预防青少年多托槽正畸治疗中 WSL 发展的长期效果。
我们进行了一项随机对照试验，纳入了来自三个不同诊所的 166 名健康青少年（12-18 岁），并将他们随机分配到试验组或安慰剂组。通过计算机程序以 15 个为一组的块生成序列号来进行随机分组。氟漆或非氟漆安慰剂漆在正畸治疗过程中每六周围绕托槽底座涂一层薄薄的一层（平均持续时间 1.7 年）。我们在正畸治疗结束后立即（基线）和结束后约 1 年，从数字照片上用四步评分法对上颌切牙、尖牙和前磨牙的唇面 WSL 患病率进行评分。检查者不参与患者的治疗，并且对分组情况不知情。
148 名患者在拆除托槽时可评估，其中 142 名患者在 1 年后可重新评估（试验组 71 名，安慰剂组 71 名）。1 年的失访率为 4.0%。在患者水平上，在随访期间，正畸后 WSL 的患病率（评分≥2）下降了 50%以上，两组之间无显著差异。在表面水平上，试验组的剩余 WSL 明显少于安慰剂组（4.5%比 10.4%；相对风险 0.44，95%置信区间 0.28-0.68）。
未检查氟化物牙膏的使用依从性，患者的全科牙医可能已经采取了额外的基于风险的预防措施。未进行成本效益分析。
本随访研究显示，FOA 治疗中使用氟漆可减少 WSL 发生，具有较小的长期获益。
NCT03725020。
方案在试验开始前未公布。
