An Abbreviated Caries Clinical Trial Design Validated over 24 Months

• 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
• Subjects: Adolescent; Analysis of Variance; caries clinical trials; Cariostatic Agents - administration & dosage; Cariostatic Agents - therapeutic use; Child; clinical visual assessment; Dental Caries - diagnosis; Dental Caries - physiopathology; Dental Caries - prevention & control; Dental Caries Susceptibility; Dental Enamel - pathology; Dental Restoration, Permanent; Dentifrices - therapeutic use; Dentin - pathology; digital radiography; Disease Progression; DMF Index; Double-Blind Method; Dundee Selectable Threshold Method; Female; fiber optic transillumination; Fluorides - administration & dosage; Fluorides - therapeutic use; Follow-Up Studies; Humans; Male; Observer Variation; Radiography, Bitewing; Reproducibility of Results; Research Design; Statistics as Topic; Tooth Extraction; Tooth Remineralization; Transillumination; Treatment Outcome; digital radiography; fiber optic transillumination; clinical visual assessment; caries clinical trials; Dundee Selectable Threshold Method
• DOI: 10.1177/154405910208100912
• ISSN: 0022-0345

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.