Summary of findings 3. Fluoride toothpaste with higher versus lower concentration of fluoride for preventing caries in children and adolescents (immature permanent dentition).

The effects of fluoride toothpaste with higher versus lower concentration of fluoride for preventing caries in children and adolescents
Population: children and adolescents between 5 and 15 years of age at the start of the study Setting: home, school Intervention: toothbrushing with higher fluoride concentration toothpaste Comparison: toothbrushing with lower fluoride concentration toothpaste Outcomes: immature permanent dentition: proportion of children developing new caries, adverse effects of toothpaste
Comparison	Outcome	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Certainty of the evidence (GRADE)	Comments
		Risk with lower fluoride concentration toothpaste	Risk with higher fluoride concentration toothpaste
Proportion of children developing new caries
250 ppm F compared with 0 ppm F	Proportion of children developing new caries Follow‐up: 24 months	451 per 1000a	483 per 1000 (411 to 636)	RR 1.07 (0.91 to 1.27)	684 (2 RCTs)	⊕⊕⊝⊝ lowb
1000 to 1250 ppm F compared with 0 ppm F	Proportion of children developing new caries Follow‐up: ranged from 12 to 60 months	596 per 1000c	536 per 1000 (459 to 632)	RR 0.90 (0.77 to 1.06)	1898 (7 RCTs)	⊕⊕⊝⊝ lowd	6 studies had follow‐up of 36 months or less
1500 ppm F compared with 0 ppm F	Proportion of children developing new caries Follow‐up: 36 months	947 per 1000e	900 per 1000 (862 to 928)	RR 0.95 (0.91 to 0.98)	945 (1 RCT)	⊕⊕⊝⊝ lowb
1450 to 1500 ppm F compared with 1000 to 1250 ppm F	Proportion of children developing new caries Follow‐up: 36 months	728 per 1000f	742 per 1000 (677 to 808)	RR 1.02 (0.93 to 1.11)	4328 (2 RCTs)	⊕⊕⊝⊝ lowg
Adverse effects of toothpaste
All comparisons	Adverse effects of toothpaste Follow‐up: closest to 36 months	16 studies assessed possible side effects arising from toothpaste use, principally in terms of oral (soft tissue) pathologies and tooth staining. 6 studiesh reported either no untoward events or no untoward events which could be attributed to the use of the toothpaste on the soft tissue. 6 studiesi reported a greater incidence of staining in the stannous fluoride group. 1 studyj reported no differential in staining between the groups (2.5% fluoride group versus 1% placebo group) and no staining was found in anotherk. No side effects of toothpaste were observed or reported in 4 studiesl
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; F: fluoride; ppm: parts per million; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

^aReported proportion in the 0 ppm F groups.
 ^bDowngraded for imprecision and study limitations (unclear risk of selection and attrition bias).
 ^cReported proportion in the 0 ppm F groups.
 ^dDowngraded for imprecision, study limitations (6 studies at unclear risk of selection or attrition bias or both, 1 study at high risk of performance and detection bias), and inconsistency (I² = 80%).
 ^eReported proportion in the 0 ppm F group.
 ^fReported proportion in the 1000 ppm F, 1250 ppm F groups.
 ^gDowngraded for imprecision, study limitations (unclear risk of selection and attrition bias and contamination/co‐intervention), and inconsistency (I² = 82%).
 ^hConti 1988; Fogels 1979; Fogels 1988; Koch 1990; Rule 1984; Stephen 1994.
 ⁱFanning 1968; James 1967; Naylor 1967; Slack 1964; Slack 1967; Slack 1967a.
 ^jJackson 1967.
 ^kFogels 1979.
 ^lFan 2008; Glass 1983; Kleber 1996; Rao 2009.