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Journal of Dental Research
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Clinical

An Abbreviated Caries Clinical Trial Design Validated over 24 Months

R.K. Chesters1,*, N.B. Pitts2, G. Matuliene3, A. Kvedariene3, E. Huntington1, R. Bendinskaite3, I. Balciuniene3, J.R. Matheson1, J.A. Nicholson1, A. Gendvilyte3, R. Sabalaite3, J. Ramanauskiene3, D. Savage1 and J. Mileriene3

1 Unilever Dental Research, Port Sunlight, Quarry Road East, Bebington, Wirral CH63 3JW, UK;
2 Dundee University, Scotland; and
3 Vilnius University, Lithuania;

Correspondence: * 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

Journal of Dental Research, Vol. 81, No. 9, 637-640 (2002)
DOI: 10.1177/154405910208100912
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This article has been cited by other articles:


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J.W. Stamm
The Classic Caries Clinical Trial: Constraints and Opportunities
Journal of Dental Research, July 1, 2004; 83(suppl_1): C6 - C14.
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Statistical Issues for Combining Multiple Caries Diagnostics for Demonstrating Caries Efficacy
Journal of Dental Research, July 1, 2004; 83(suppl_1): C109 - C112.
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R.K. Chesters, R.P. Ellwood, A.R. Biesbrock, and S.R. Smith
Potential Modern Alternative Designs for Caries Clinical Trials (CCTs) and How These can be Validated against the Conventional Model
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