Xin Weini, Leung Katherine Chiu Man, Lo Edward Chin Man, Mok Mo Yin, Leung Moon Ho
Dental Care Center, The No.1 Affiliated Hospital of Shantou Medical College, Shantou, China.
Prosthodontics, Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.
BMC Oral Health. 2016 Sep 23;16(1):102. doi: 10.1186/s12903-016-0296-7.
Sjögren's syndrome (SS) patients are prone to caries development due to reduction of salivary flow. Topical fluoride is commonly prescribed for caries prevention.
In this 24-month randomized, double-blind, placebo-controlled clinical trial, SS patients were randomly assigned to receive either fluoride varnish or placebo gel quarterly. Development and arrest of caries at the coronal and root surfaces were recorded at 12-month and 24-month and compared to that of the baseline. Effect of fluoride varnish on oral Candida and lactobacilli colonization was explored by comparing baseline oral microbiological assessments to data obtained at 12-month and 24-month.
Seventy-eight SS patients (mean age = 50 years, 2 men) completed this trial. At 24-month, the mean new coronal enamel caries were 1.6 surfaces in both groups, and new dentin caries were 1.4 and 2.7 surfaces in the fluoride and placebo group respectively (p > 0.05). Mean arrested caries were 0.6 and 0.7 surfaces for fluoride and placebo groups respectively and that of root caries were 0.3 and 0.1 surfaces (p > 0.05). The mean oral Candida count was reduced by 30 % in the fluoride group but increased 61 % in the placebo group while no change in oral lactobacilli counts in both groups at 24 months (p > 0.05). SS patients receiving fluoride varnish were significantly less likely to develop dentin caries (p < 0.05). In contrast, those with high baseline DMFS scores (p = 0.05), harbored mixed Candida species (p < 0.05), or unstimulated whole saliva at low pH (p < 0.01) were significantly more likely to develop dentin caries.
Results of this randomized clinical trial did not provide clear evidence to support or refute that quarterly applications of fluoride varnish can prevent development of dental caries in people with Sjögren's syndrome.
This study was retrospectively registered at the ISRCTN registry ( ISRCTN85164658 ) on 9 Sept 2016 and was funded by the Research Grant Council of Hong Kong.
干燥综合征（SS）患者由于唾液分泌减少，易患龋齿。局部用氟化物常用于预防龋齿。
在这项为期24个月的随机、双盲、安慰剂对照临床试验中，SS患者被随机分配，每季度接受一次氟化漆或安慰剂凝胶治疗。在12个月和24个月时记录冠部和根部表面龋齿的发生和静止情况，并与基线情况进行比较。通过比较基线口腔微生物学评估结果与在12个月和24个月时获得的数据，探讨氟化漆对口腔念珠菌和乳酸杆菌定植的影响。
78名SS患者（平均年龄 = 50岁，2名男性）完成了该试验。在24个月时，两组的平均新发冠部釉质龋均为1.6个面，氟化漆组和安慰剂组的新发牙本质龋分别为1.4个面和2.7个面（p > 0.05）。氟化漆组和安慰剂组的平均静止龋分别为0.6个面和0.7个面，根面龋分别为0.3个面和0.1个面（p > 0.05）。24个月时，氟化漆组的平均口腔念珠菌计数减少了30%，而安慰剂组增加了61%，两组的口腔乳酸杆菌计数均无变化（p > 0.05）。接受氟化漆治疗的SS患者发生牙本质龋的可能性显著降低（p < 0.05）。相比之下，基线DMFS评分高（p = 0.05）、携带混合念珠菌种（p < 0.05）或非刺激性全唾液pH值低（p < 0.01）的患者发生牙本质龋的可能性显著更高。
这项随机临床试验的结果没有提供明确证据支持或反驳每季度应用氟化漆可预防干燥综合征患者龋齿的发生。
本研究于2016年9月9日在国际标准随机对照试验编号注册库（ISRCTN85164658）进行回顾性注册，由香港研究资助局资助。
