声波震动牙刷对儿童牙菌斑控制的有效性及安全性评价

A clinical investigation of plaque control efficacy and safety of Sonicare toothbrush in children

目的:通过比较声波震动牙刷和手动牙刷对儿童刷牙效率的影响及安全性,为儿童口腔卫生指导及牙病预防提供理论依据。方法:纳入健康儿童180例,3~6岁、6~9岁各90例。2个年龄组受试者随机分为声波震动牙刷(SFK)组及手动牙刷(MTB)组。在28天试验期内,按分组使用声波震动牙刷或者手动牙刷进行菌斑控制。于试验基线期、第7天及第28天(D0、D7、D28)对口腔卫生相关指数进行检查、记录菌斑指数(Rustogi modified Navy plaque index,RMNPI),采用R软件进行统计学分析。结果:MTB和SFK均能去除部分牙菌斑,3~6岁的SFK组在D0、D7、D28天的菌斑清除率(17.09%±14.4%、27.14%±11.4%、33.52%±18.3%)均显著高于相应MTB组(11.86%±9.7%、11.83%±9.1%,13.73%±11.0%)(P<0.05);6~9岁的SFK组在D0、D7、D28天的菌斑清除率(20.05%±10.52%、22.76%±13.46%、22.31%±9.74%)均显著高于相应MTB组(9.15%±7.07%、7.26%±6.81%,11.54%±8.27%)(P<0.05)。进一步分析发现,3~6岁SFK组随访牙菌斑指数逐渐降低(P<0.05),声波震动牙刷具有良好的儿童使用依从性及安全性。结论:声波震动牙刷可有效去除儿童牙菌斑,长期使用可有效控制儿童牙菌斑,提高儿童口腔卫生质量,是一种可推广的日常儿童牙菌斑控制手段。

PURPOSE：To provide theoretical basis for children＇s oral health instruction and children＇s dental prophylaxis by comparing the plaque control efficacy and safety of Sonicare and manual toothbrush in 3-9 years old children.METHODS：One hundred and eighty healthy children were included in this study and were divided into 2 groups with90 children in each group：aged 3-6 years and 6-9 years respectively.In each group,the subjects were randomly instructed to use either Sonicare for kids（SFK） or manual tooth brush（MTB）.During a 28-day clinical trial period,oral hygiene was examined and plaque index（Rustogi modified Navy plaque index,RMNPI） was recorded at baseline,and at visits on the 7 th and the 28 th day（D0,D7,D28）.The data were analyzed by R software.RESULTS：Both MTB and SFK could remove a certain amount of dental plaque.In the group of 3-6 years old children,the plaque reduction rates of children using SFK were 17.09% ±14.4%（D0）,27.14% ±11.4%（D7）,33.52% ±18.3%（D28）,respectively,which were significantly higher than that of children using MTB [11.86%±9.7%（D0）,11.83%±9.1%（D7）,13.73%±11.0%（D28）]（P〈0.05）.Similarly,in the group of 6-9 years old children,the plaque reduction rates of children using SFK were 20.05% ±10.52%（D0）,22.76%±13.46%（D7）,22.31%±9.74%（D28）,which were significantly higher than that of children using MTB[9.15%±7.07%（D0）,7.26%±6.81%（D7）,11.54%±8.27%（D28）]（P0.05）.Further analysis revealed that the plaque index was decreased gradually in 3-6 years old children using SFK after 3 months of follow-up（P〈0.05）.In addition,there was better compliance and safety in children using SFK.CONCLUSIONS：Sonicare can remove plaque efficiently,and can control plaque and improve oral hygiene quality effectively in children in a long period,which implies that the application of Sonicare is worthy of promoting to control dental plaque in children.