Assim Samar H, Yassir Yassir A
Postgraduate Student, Department of Orthodontics, College of Dentistry, University of Baghdad, Iraq.
Professor of Orthodontics, Department of Orthodontics, College of Dentistry, University of Baghdad, Iraq.
J Taibah Univ Med Sci. 2025 Jun 25;20(3):405-416. doi: 10.1016/j.jtumed.2025.06.004. eCollection 2025 Jun.
The use of orthodontic fixed appliances is strongly linked to enamel demineralization. Numerous solutions have been presented; however, the best one remains controversial.
To evaluate the effect of Biosmalto Impact Action Mousse™ (biomimetic materials) on white spot lesions (WSLs) development during orthodontic treatment.
Multicenter, parallel groups, randomized clinical trial.
A computer random number generator allocated 70 orthodontic patients aged 12 or older to two groups. The control group used Colgate toothpaste daily, whereas the intervention group used Curasept toothpaste daily with the application of Curasept Biosmalto Impact Action Mousse™ to the anterior teeth every visit. The individuals were assessed monthly for six months. Enamel mineralization, visible plaque index (VPI), and gingival bleeding index (GBI) were measured on the upper and lower anterior teeth. Each tooth was assessed for enamel mineralization using the DIAGNOdent Pen, International Caries Detection and Assessment System (ICDAS), and Gorelick index (GOI).
The analysis included 62 participants (30 Colgate and 32 Curasept). Both groups had comparable DIAGNOdent pen scores at all time intervals. There was a statistically significant higher DIAGNOdent pen scores over time in both groups. No statistically significant differences were found between groups for ICDAS and GOI. The Colgate group had statistically significantly higher VPI scores at T2 (after 8 weeks), T4 (after 16 weeks), T5 (after 20 weeks), and T6 (after 24 weeks) and GBI scores at T4, T5, and T6.
The study findings only demonstrated the effect of biomimetic materials during six months of orthodontic treatment. Long-term effect is worth to be also evaluated.
Monthly application of Biosmalto Impact Action Mousse™ did not seem to be more effective than fluoridated toothpaste on the development of WSLs after six months.
The study was registered with ClinicalTrials.gov on July 11, 2023 (Registration No. NCT05940701).
正畸固定矫治器的使用与牙釉质脱矿密切相关。已经提出了许多解决方案；然而，最佳方案仍存在争议。
评估生物仿生材料Biosmalto Impact Action Mousse™对正畸治疗期间白斑病变（WSLs）发展的影响。
多中心、平行组、随机临床试验。
使用计算机随机数生成器将70名12岁及以上的正畸患者分为两组。对照组每天使用高露洁牙膏，而干预组每天使用Curasept牙膏，每次就诊时在前牙涂抹Curasept Biosmalto Impact Action Mousse™。对个体进行为期六个月的每月评估。测量上下前牙的牙釉质矿化、可见菌斑指数（VPI）和牙龈出血指数（GBI）。使用DIAGNOdent Pen、国际龋病检测与评估系统（ICDAS）和戈列克指数（GOI）评估每颗牙齿的牙釉质矿化情况。
分析纳入了62名参与者（30名使用高露洁牙膏，32名使用Curasept牙膏）。两组在所有时间间隔的DIAGNOdent Pen评分均具有可比性。两组随时间推移的DIAGNOdent Pen评分均有统计学意义的升高。两组在ICDAS和GOI方面未发现统计学上的显著差异。高露洁组在T2（8周后）、T4（16周后）、T5（20周后）和T6（24周后）的VPI评分以及在T4、T5和T6的GBI评分在统计学上显著更高。
研究结果仅证明了生物仿生材料在正畸治疗六个月期间的效果。长期效果也值得评估。
在六个月后，每月使用Biosmalto Impact Action Mousse™在预防白斑病变发展方面似乎并不比含氟牙膏更有效。
该研究于2023年7月11日在ClinicalTrials.gov注册（注册号：NCT05940701）。
