Cochrane · intervention · CD011850
Fluoride supplementation (with tablets, drops, lozenges or chewing gum) in pregnant women for preventing dental caries in the primary teeth of their children
Takahashi, R, Ota, E, Hoshi, K, et al. · Cochrane Database of Systematic Reviews · 2017 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
13
current version
GRADE rated
6
No studies
2
Included studies
1
as reported
No studies 2 · 15.4%Ungraded 5 · 38.5%Very low 6 · 46.2%Low 0 · 0%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Pregnant women, regardless of their dental caries, exposure to fluorides, level of dental treatment, nationality or level of education; the women may or may not have had access to fluoridated water | One RCT (Leverett 1997): 1400 pregnant women in the first trimester in communities served by fluoride-deficient drinking water; 1175 babies born; 938 children followed up at 3 years (intervention 464 vs control 484); 798 followed up at 5 years (intervention 398 vs control 400) |
| Intervention | Fluoride supplementation (tablets, drops, lozenges or chewing gum) of any dosage, frequency, duration and timing of delivery, which may or may not include topical fluorides, compared with no fluoride supplementation | Sodium fluoride (NaF) 2.2 mg (1 mg active fluoride ion) tablet daily from the fourth month of pregnancy (n=464 at 3 years, n=398 at 5 years) |
| Comparison | No treatment or placebo | Placebo tablets (no fluoride during pregnancy) (n=484 at 3 years, n=400 at 5 years); both groups received fluoride drops from birth to 2 years and a 0.5 mg tablet daily for ages 2 to 3 |
| Outcomes | Number of children with caries in the primary teeth; Decayed, missing and filled primary teeth (dmft) and components; Decayed, missing and filled primary tooth surfaces (dmfs) and components; Fluorosis; Adverse effects apart from fluorosis | Children with caries in the primary teeth at 3 years (n=938) and 5 years (n=798); Decayed primary surfaces at 3 years (n=938) and 5 years (n=798); Filled primary surfaces at 3 years (n=938) and 5 years (n=798); Decayed or filled primary surfaces at 3 years (n=938) and 5 years (n=798); Fluorosis maxillary teeth at 5 years (n=798); Fluorosis mandibular teeth at 5 years (n=798); dmft not assessed; missing surfaces not assessed; no other adverse effects reported |
| Study designs | Randomised controlled trials (RCTs), including quasi-randomised and cluster-randomised trials; cross-over trials and observational studies excluded | One individually randomised RCT (Leverett 1997); no cluster-randomised trials included |
| Timing | Deciduous teeth of children up to 6 years of age | Follow-up at 3 years (n=938) and 5 years (n=798) |
Search date: 2017-01. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; LILACS BIREME Virtual Health Library; CINAHL EBSCO; US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov; World Health Organization International…
Questions and results
Current version onlyFluoride supplementation (tablets, drops, lozenges or chewing gum) vs Placebo or no treatment
Population: Pregnant women (for preventing dental caries in the primary teeth of their children)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Fluorosis (maxillary teeth) at 5 years 5 years | RR 1.79 [0.95, 3.40] 35 per 1000 vs 63 per 1000 | 1 study · 798 participants | Very low Downgraded: risk of bias, imprecision |
Missing primary surfaces (ms) | no estimate extracted | NR | No studies |
Decayed primary surfaces at 3 years 3 years | MD 0.05 [-0.02, 0.12] | 1 study · 938 participants | Ungraded |
Filled primary surfaces at 5 years 5 years | MD 0.03 [-0.28, 0.34] | 1 study · 798 participants | Ungraded |
Children with caries in the primary teeth at 3 years 3 years | RR 1.46 [0.75, 2.85] 30 per 1000 vs 43 per 1000 | 1 study · 938 participants | Very low Downgraded: risk of bias, imprecision |
Decayed, missing and filled primary teeth (dmft) | no estimate extracted | NR | No studies |
Fluorosis (mandibular teeth) at 5 years 5 years | RR 0.89 [0.35, 2.29] | 1 study · 798 participants | Very low Downgraded: risk of bias, imprecision |
Children with caries in the primary teeth at 5 years 5 years | RR 0.84 [0.53, 1.33] | 1 study · 798 participants | Very low Downgraded: risk of bias, imprecision |
Adverse effects (apart from fluorosis) | no estimate extracted | 1 study | Ungraded |
Filled primary surfaces at 3 years 3 years | MD 0.07 [-0.07, 0.21] | 1 study · 938 participants | Ungraded |
Decayed or filled primary tooth surfaces at 3 years 3 years | MD 0.12 [-0.05, 0.29] | 1 study · 938 participants | Very low Downgraded: risk of bias, imprecision |
Decayed or filled primary tooth surfaces at 5 years 5 years | MD -0.05 [-0.42, 0.32] | 1 study · 798 participants | Very low Downgraded: risk of bias, imprecision |
Decayed primary surfaces at 5 years 5 years | MD -0.06 [-0.17, 0.05] | 1 study · 798 participants | Ungraded |
Fluoride supplementation (tablets, drops, lozenges or chewing gum) vs Placebo or no treatment
Population: Pregnant women (for preventing dental caries in the primary teeth of their children)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Percentage of children with no caries in the primary teeth (planned secondary outcome) Up to 6 years of age | no estimate extracted | NR | No studies |
Decayed, missing and filled primary teeth (dmft) (planned primary outcome) Up to 6 years of age | no estimate extracted | NR | No studies |
Adverse effects, including dental or skeletal fluorosis, miscarriage, premature delivery (planned primary outcome) Up to 6 years of age | no estimate extracted | NR | No studies |
Decayed, missing and filled primary tooth surfaces (dmfs) (planned primary outcome) Up to 6 years of age | no estimate extracted | NR | No studies |