Non-profit Organisation "Promoting Scientific Assessment in Prevention of Tooth Decay and Gum Disease", Tokyo, Japan.
Oral Health Services Research Centre, University College Cork, Cork, Republic of Ireland.
BMC Oral Health. 2019 Mar 12;19(1):44. doi: 10.1186/s12903-019-0729-1.
In the Republic of Ireland (RoI), fluoridation has been effective and efficient for caries prevention at population level, regardless of income status; however, at individual level it still has limitations. This study aimed to compare personalised versus non-personalised text messaging on 'chance of avoiding new cavities' with the Cariogram, a computer-based caries risk assessment (CRA) model, in an economically disadvantaged adult population in the RoI.
The intervention was via a CRA summary letter plus 24 weekly personalised mobile-phone short text messages (text messages) based on the individual's CRA, compared with a non-personalised approach via a non-personalised letter and a predetermined, fixed set of 24 weekly text messages. The study was designed as a two-arm parallel-group, single-blinded (assessor), randomised controlled study in County Cork, RoI. The primary outcome was a comparison of 'chance of avoiding new cavities' calculated by the Cariogram with clinical examination, interview, CRT® (Ivoclar Vivadent, Liechtenstein) and three-day food diary between the two groups at follow-up. We combined stratified randomisation with blocked randomisation for 171 participants who completed baseline. Of them, 111 completed follow-up and were analysed (56 and 55 from the personalised and non-personalised groups, respectively). Due to protocol violations, both intent-to-treat (ITT) and per-protocol analyses were conducted.
The ITT analysis did not show a personalised intervention effect on 'chance of avoiding new cavities'. Of the secondary outcome measures, only the stimulated saliva flow factor showed a personalised intervention effect, p = 0.036, OR = 0.3 (95% CI = 0.1, 0.9). The per-protocol analysis with 21 personalised and 33 non-personalised participants within two-message deviations showed no significant effect on 'chance of avoiding new cavities'.
The null hypothesis in regard to the primary outcome for both ITT and per-protocol analyses was not rejected; however, as the minimal clinically important difference was included in the 95% CI for the per-protocol analysis, replication studies will be worth conducting to explore the potential of mobile devices for individual caries risk reduction.
University Hospital Medical Information Network Clinical Trials Registry ( UMIN000027253 ) on 10 May 2017. The study was retrospectively registered.
在爱尔兰共和国（RoI），无论收入状况如何，氟化物在人群层面上对预防龋齿都是有效和高效的；然而，在个体层面上，它仍然存在局限性。本研究旨在比较基于个人的短信与非个人的短信，以及基于计算机的龋齿风险评估（CRA）模型的 Cariogram，在 RoI 的经济弱势群体中，对“避免新龋齿的机会”的影响。
干预措施是通过 CRA 总结信加上基于个人 CRA 的 24 周个性化手机短信（短信），与非个性化方法相比，通过非个性化信件和一组预定的、固定的 24 周短信。该研究设计为 RoI 科克县的一项双臂平行组、单盲（评估者）、随机对照研究。主要结局是通过 Cariogram 与临床检查、访谈、CRT®（Ivoclar Vivadent，列支敦士登）和三天食物日记比较两组在随访时的“避免新龋齿的机会”。我们对 171 名完成基线的参与者进行了分层随机化和分组随机化。其中，111 名完成了随访并进行了分析（个性化组和非个性化组各 56 名和 55 名）。由于违反方案，我们进行了意向治疗（ITT）和符合方案分析。
ITT 分析未显示个性化干预对“避免新龋齿的机会”有影响。在次要结局指标中，只有刺激唾液流量因素显示出个性化干预的效果，p=0.036，OR=0.3（95%CI=0.1, 0.9）。在符合方案分析中，21 名个性化参与者和 33 名非个性化参与者在两条短信偏差内，未显示对“避免新龋齿的机会”有显著影响。
ITT 和符合方案分析的主要结局的零假设均未被拒绝；然而，由于最小临床重要差异包含在符合方案分析的 95%CI 内，因此值得进行复制研究，以探索移动设备降低个体龋齿风险的潜力。
2017 年 5 月 10 日，在大学医院医疗信息网络临床试验注册中心（UMIN000027253）注册。该研究是回顾性注册的。
