Randomised controlled trials (RCTs) of fluoride supplementation to prevent dental caries in children aged up to 16 years were eligible for inclusion as effectiveness studies. Studies were required to compare a group that received fluoride tablets, lozenges or drops (with or without use of fluoride toothpaste) versus controls not exposed to any source of systemic fluoride (water, salt or milk). Studies that reported data suitable for meta-analysis on the independent contribution of fluoride supplements in children to their risk of fluorosis were eligible for inclusion as fluorosis studies.
Most participants in the included effectiveness studies were younger than five years old (range prenatal to 16 years). About half of the studies used fluoride regimens similar to those recommended by the American Dental Association (ADA). Interventions included fluoride tablets, drops, lozenges, mouthwash and/or varnish, with or without vitamins. Control interventions included placebo, vitamins or alternative types of fluoride supplementation (toothpaste, fluoridated water). Outcomes were measured with various scoring tools for decayed, missing or filled surfaces of primary and/or permanent teeth. Duration of follow-up ranged from two to 11.5 years (where reported).
In the fluorosis studies, participant ages ranged from six months to 14 years. Outcomes were prevalence of fluorosis and fluorosis severity score with a variety of scoring tools. Only fluorosis studies published since a previous systematic review (see Other Publications of Related Interest) were reported in detail in the current review.
More than one reviewer selected the studies. Disagreements were resolved by consensus.