An abbreviated caries clinical trial design validated over 24 months

TY - JOUR

T1 - An abbreviated caries clinical trial design validated over 24 months

AU - Chesters, R. K.

AU - Pitts, N. B.

AU - Matuliene, G.

AU - Kvedariene, A.

AU - Huntington, E.

AU - Bendinskaite, R.

AU - Balciuniene, I.

AU - Matheson, J. R.

AU - Nicholson, J. A.

AU - Gendvilyte, A.

AU - Sabalaite, R.

AU - Ramanauskiene, J.

AU - Savage, D.

AU - Mileriene, J.

N1 - dc.publisher: Sage This full report of the industry-funded testing a novel “abbreviated carried clinical trial” design, compared back to back with the accepted international-standard trial design using products of known efficacy.

PY - 2002

Y1 - 2002

N2 - 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.

AB - 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.

KW - Caries clinical trials

KW - Fibre optic transillumination

KW - Clinical visual assessment

KW - Dundee selectable threshold method

KW - Digital radiography

U2 - 10.1177/154405910208100912

DO - 10.1177/154405910208100912

M3 - Article

SN - 0022-0345

VL - 81

SP - 637

EP - 640

JO - Journal of Dental Research

JF - Journal of Dental Research

IS - 9

ER -