An Abbreviated Caries Clinical Trial Design Validated over 24 Months

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...

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Bibliographic Details
Published in:Journal of dental research Vol. 81; no. 9; pp. 637 - 640
Main Authors: Chesters, R.K., Pitts, N.B., Matuliene, G., Kvedariene, A., Huntington, E., Bendinskaite, R., Balciuniene, I., Matheson, J.R., Nicholson, J.A., Gendvilyte, A., Sabalaite, R., Ramanauskiene, J., Savage, D., Mileriene, J.
Format: Journal Article
Language:English
Published: United States SAGE Publications 01-09-2002
SAGE PUBLICATIONS, INC
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Summary: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.
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ISSN:0022-0345
1544-0591
DOI:10.1177/154405910208100912