Hammad Shaza M, Knösel Michael
Department of Orthodontics, Faculty of Dentistry, Mansoura University, El Gomhoria Street, Mansoura, 35516, Egypt.
Department of Orthodontics, University Medical Center Göttingen (UMG), Göttingen, Germany.
J Orofac Orthop. 2016 Nov;77(6):439-445. doi: 10.1007/s00056-016-0052-2. Epub 2016 Oct 12.
White spot lesions (WSLs) are an undesirable side effect of fixed orthodontic appliance therapy and are reported to occur in 2-96 % of orthodontic patients. In this study, the efficacy of a new sealant to prevent WSLs during fixed orthodontic treatment was compared to a control group that did not receive sealant.
For this 2-arm parallel-group randomized trial, 50 subjects aged 12-18 years (mean age 14.57 ± 2.04 years) were recruited from the orthodontics department at Mansoura University, Egypt. Eligibility criteria were no restorations, no active WSLs or caries, and adequate oral hygiene. Subjects were randomized in a 1:1 ratio to one of the two arms prior to undergoing fixed orthodontic treatment, namely a single application of SeLECT Defense™ sealant during the bracketing appointment or no sealant (control arm). Instructions and dentifrices for local home fluoridation regimen were identical in both groups. Oral hygiene was assessed using the Approximal Plaque Index (API) at specified time intervals. Dental photographs were taken for blinded WSLs assessment; inter- and intra-operator error were also calculated. Categorical data were tested using the χ test, and a logistic regression model was adopted to detect associations between decalcification (WSLs), sealant application, and oral hygiene status.
Only excellent or good oral hygiene were independent prognostic factors for preventing severe WSLs (p = 0.035). No significant effect on caries incidence was observed for the sealant.
In combination with adequate oral hygiene SeLECT Defense™ helps to reduced the frequency of WSLs. However, the sealat showed no significant effect as sole preventive strategy.
白斑病变（WSLs）是固定正畸矫治器治疗的不良副作用，据报道，2% - 96%的正畸患者会出现这种情况。在本研究中，将一种新型防龋剂在固定正畸治疗期间预防WSLs的效果与未使用防龋剂的对照组进行了比较。
在埃及曼苏拉大学正畸科招募了50名年龄在12 - 18岁（平均年龄14.57±2.04岁）的受试者，进行这项双臂平行组随机试验。入选标准为无修复体、无活动性WSLs或龋齿，且口腔卫生良好。在接受固定正畸治疗前，受试者按1:1的比例随机分为两组，即一组在粘托槽时单次使用SeLECT Defense™防龋剂，另一组不使用防龋剂（对照组）。两组的局部家庭用氟方案的说明和牙膏相同。在特定时间间隔使用邻面菌斑指数（API）评估口腔卫生状况。拍摄牙齿照片以进行WSLs的盲法评估，并计算操作者间和操作者内误差。分类数据采用χ检验，采用逻辑回归模型检测脱矿（WSLs）、防龋剂应用和口腔卫生状况之间的关联。
只有良好或优秀的口腔卫生是预防严重WSLs的独立预后因素（p = 0.035）。防龋剂对龋齿发病率没有显著影响。
SeLECT Defense™与良好的口腔卫生相结合有助于降低WSLs的发生率。然而，作为唯一的预防策略，防龋剂并未显示出显著效果。
