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RESEARCH REPORT |
1 Unilever Dental Research, Port Sunlight, Quarry Road East, Bebington, Wirral CH63 3JW, UK;
2 Dundee University, Scotland; and
3 Vilnius University, Lithuania;
* corresponding author, Richard.Chesters{at}Unilever.com
Conventional caries trials last from 24 to 36 months. This study evaluated whether the previously established difference in efficacy between 1000- and 2500-ppm-fluoride dentifrices could be detected after 12 months. Caries was assessed by clinical visual assessment (CVA-simplified version of Dundee Selectable Threshold Method - DSTM), bitewing radiography, and Fiber Optic Transillumination (FOTI). Changes in status for individual surfaces were classified by means of pre-prepared matrices as 0 (unchanged), +1 (initiation or progression), or -1 (regression) and summed for each subject to yield an event score. Mean group event scores were calculated for each product. DSTM at the D1 [enamel and dentin] threshold showed significant inter-group differences in mean event scores (p < 0.003) and D1MFS increment (< 0.007) at 12 months; these were confirmed at 24 months by traditional increment analysis (CVA & FOTI at the D3 (dentin only) threshold + radiography, p < 0.03). This study confirms the validity of an abbreviated trial protocol.
KEY WORDS: caries clinical trials fiber optic transillumination clinical visual assessment Dundee Selectable Threshold Method digital radiography
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