Randomised and quasi-randomised studies that compared fluoride toothpaste only versus placebo or no intervention were eligible for inclusion. Observational and non-randomised studies had to report a minimum follow-up of one year. The population of interest was children in the primary dentition phase without special general or oral health conditions, aged no more than seven years at outcome assessment. Studies were required to report on the numbers of filled teeth, teeth or surfaces that were decayed or missing due to caries, and the proportion of children who developed dental caries in primary dentition. Caries had to be reported separately for enamel and dentine levels, and at cavitated and non-cavitated stages.
Included studies were conducted in China, England and Lithuania and published between 1998 and 2008. Most studies included oral health education as part of the intervention alongside fluoride toothpaste, most control groups received no interventions with only one study reported giving oral health advice to the control participants. Concentration of the fluoride toothpastes varied between 440ppm and 1450ppm. Water fluoridation was either not reported (two studies), not present or present at levels below 0.35ppm.
Two independent reviewers assessed the studies for inclusion. Any disagreement was solved by consensus after consulting a third reviewer.