Kleber 1996.
| Methods | Trial design: a3‐armed, double‐blind, placebo‐controlled and stratified RCT Location: USA Number of centres: 3 rural elementary schools in North‐Central Indiana Recruitment period: study commenced in/before 1994 | |
| Participants | Inclusion criteria: children lacking dental care and caries‐susceptible; good general health; no serious medical condition/transmissible diseases
Exclusion criteria: absence of dmfs/t/DMFS/T; undergoing orthodontic treatment
Baseline caries: 4.2 DMFS (Gp A: 4.38 DMFS (SD 5.35)/2.81 DMFT (SD 2.81); Gp B: 3.95 DMFS (SD 4.53)/2.73 DMFT (SD 2.58)). Baseline characteristics (DMFS, DMFT) "balanced"
Age at baseline (years): range 10 to 11 years, mean 10.7 years (Gp A: 10.7 years; Gp B: 10.6 years). Baseline characteristic (age) "balanced"
Sex: Gp A: 42 M:45 F; Gp B: 42 M:45 F. Baseline characteristic (sex) "balanced" Any other details of important prognostic factors: no background exposure to fluoride reported. Community water supplies < 0.4 ppm F; request to dentists in area not to apply topical fluoride to study population children Number randomised: 174 (Gp A: 87; Gp B: 87) Number evaluated: 156 at 1 year (present at final assessment. Gp A: 77; Gp B: 79) Attrition: 10% dropout after 1 year (study duration = 1 year). Main reasons for attrition: changes in residence, few exclusions for initiation of orthodontic treatment; no differential group losses |
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| Interventions | Comparison: FT (+ Al rinse) versus PL (+ Al rinse)b Gp A (n = 87): NaF 1100 ppm F; abrasive system: silica; home use/unsupervised, daily frequency assumed Gp B (n = 87): placebo; abrasive system: silica; home use/unsupervised, daily frequency assumed | |
| Outcomes | Primary: 1‐year DMFS increment ‐ (CA) cl + (ER) xr; DMFT; proportion of children with new DMFS; proportion of children remaining caries free (at 6 months, 1 year) Secondary: adverse effects (oral soft tissues lesions) (at 6 months, 1 year) Assessments irrelevant to this review's scope: compliance Follow‐up duration: 1 year | |
| Notes | Adverse effects: "No adverse oral effects attributable to any treatment regimens were observed during the study. Due to the low incidence of soft tissue aberrations in this population, the soft tissue findings are not presented" Funding source: not reported Declarations/conflicts of interest: institutional affiliations reported only Data handling by review authors: results of 1 examiner chosen (findings consistent throughout). aThird trial arm (fluoride toothpaste and no mouthrinse) excluded from this review due to no eligible comparator arm. bRinsing with 500 ppm Al solutions performed daily at school in both relevant groups compared. Clinical (VT) caries assessment by 2 examiners, diagnostic threshold = CA; state of tooth eruption included = E/U. Radiographic assessment (postBW) by 2 examiners (independently), diagnostic threshold = ER. Reversals were small in both groups and equally common | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Subjects with evidence of caries activity were stratified according to age, sex... then randomly assigned to one of the balanced groups" Comment: not enough information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quotes: "A double blind comparison of three parallel groups of children... who used a test or placebo dentifrice for a twelve month period" and "Radiographs were scored independently by each examiner at a later date.." Comment: blind outcome assessment and use of placebo described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Overall dropout for length of follow‐up: 10% in 1 year. Dropout by group: 10/87 FT, 8/87 PL. Reasons for losses: changes in residence, exclusion based on orthodontic treatment Comment: numbers lost were not unduly high given the length of follow‐up with no differential losses between groups. Reasons for the missing outcome data are acceptable. Caries data used in analysis pertain to participants present at final examination |
| Selective reporting (reporting bias) | Low risk | Outcomes reported:
DMFS increment ‐ (CA) cl + (ER) xr, reported at 6 months and 1 year follow‐ups
DMFT
proportion of children remaining caries free
proportion of children with new DMFS
oral soft tissues lesions Comment: trial protocol not available. All pre‐specified outcomes (in Methods) were reported and were reported in the pre‐specified way |
| Baseline characteristics balanced? | Low risk | Prognostic factors reported:
DMFS: 5.06 (0.58) FT, 4.78 (0.50) PL DMFT: 3.31 (0.32) FT, 3.32 (0.27) PL Age: 10.7 FT, 10.6 PL Sex: 42 M, 45 F (FT); 42 M, 45 F (PL). Comment: initial caries appears balanced between groups |
| Free of contamination/co‐intervention? | Low risk | Quote: "Sufficient quantities of the respective products were provided for the participants and their families to use throughout the study. Participants with the same telephone number or address were assigned to the same group to avoid confusion with different test products in the same household" Comment: there is sufficient indication overall of prevention of contamination/co‐intervention |