Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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'. CONCLUSIONS: 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. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry ( UMIN000027253 ) on 10 May 2017. The study was retrospectively registered.