An abbreviated caries clinical trial design validated over 24 months

J Dent Res. 2002 Sep;81(9):637-40. doi: 10.1177/154405910208100912.

Abstract

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 D(1) [enamel and dentin] threshold showed significant inter-group differences in mean event scores (p < 0.003) and D(1)MFS increment (< 0.007) at 12 months; these were confirmed at 24 months by traditional increment analysis (CVA & FOTI at the D(3) (dentin only) threshold + radiography, p < 0.03). This study confirms the validity of an abbreviated trial protocol.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Analysis of Variance
  • Cariostatic Agents / administration & dosage
  • Cariostatic Agents / therapeutic use*
  • Child
  • DMF Index
  • Dental Caries / diagnosis
  • Dental Caries / physiopathology
  • Dental Caries / prevention & control*
  • Dental Caries Susceptibility
  • Dental Enamel / pathology
  • Dental Restoration, Permanent
  • Dentifrices / therapeutic use*
  • Dentin / pathology
  • Disease Progression
  • Double-Blind Method
  • Female
  • 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

Substances

  • Cariostatic Agents
  • Dentifrices
  • Fluorides