Fanning 1968.
| Methods | Trial design: 3‐armed, double‐blind, active/placebo‐controlled and stratified RCT Location: Australia Number of centres: 10 secondary schools, across Adelaide metropolitan area Recruitment period: study commenced 1964 | |
| Participants | Inclusion criteria: children with completed adolescent dentitions Exclusion criteria: fixed orthodontic appliance use; prior fluoride exposure by tablet‐form or topically Baseline caries: 19.8 DMFS (from sample randomised) (Gp A: 19.84 DMFS/10.39 DMFT; Gp B: 19.89 DMFS/10.39 DMFT). Baseline characteristics (DMFS, DMFT, SAR) "balanced" Age at baseline (years): range 12 to 14 years, mean 13 years (age distribution by group unreported) Sex: distribution of sex by group, or overall unreported Any other details of important prognostic factors: no background exposure to fluoride reported Number randomised: 2364 (1576 for Gps A and B ‐ Gp A: 788; Gp B: 788). Note: Gp C (excluded**): 788 Number evaluated: 1266 at 2 yrs (844 for Gps A&B ‐ Gp A: 422; Gp B: 422). Note: Gp C (excluded**): 422 Attrition: 22% natural dropout after 2 years; no differential group losses (46% dropout based on analysis performed for randomised block design); Gp A: 139/788; Gp B: 163/788 | |
| Interventions | Comparison: FTa versus PL Gp A (n = 788): SnF2 1000 ppm F; IMP abrasive system; home use/unsupervised, daily frequency assumed Gp B (n = 788): placebo; IMP abrasive system; home use/unsupervised, daily frequency assumed | |
| Outcomes | Primary: 2‐year DMFS increment ‐ (CA) cl + (ER) xr Secondary: stain score Assessments irrelevant to this review's scope: calculus; periodontal indices Follow‐up duration: 2 years | |
| Notes | Adverse effects: stain score: "the increment for stain in group A, stannous fluoride, was significantly larger (P < 0.001) than for the other two groups" Funding source: "the research project was supported through a grant from Colgate‐Palmolive Pty, Ltd. Toothbrushes were supplied by Johnson and Johnson Pty, Ltd" Declarations/conflicts of interest: not reported Data handling by review authors: aNa N‐lauroyl sarcosinate/SMFP 1000 ppm F toothpaste group not considered (additional non‐F active agent used in this group only) Other information of note: clinical (VT) caries assessment by 2 examiners, diagnostic threshold = CA. Radiographic assessment (5 BW) by 2 examiners, diagnostic threshold = ER. State of tooth eruption included = E/U. Intra‐ and inter‐examiner reproducibility of clinical caries diagnosis (DFS) assessed annually by duplicate examination of 10% random sample ("error relatively small, NS difference between or within examiners") | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Within each school students were separated into groups according to sex and examiner; within each group they were listed in order of increasing DMFS, and then allotted at random to the treatments by the method of taking successive groups of three subjects from the ordered lists... in a randomised block design" |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "At no time was it possible for the examiners or recorders to identify a subject with a dentifrice group.... subjects did not know what dentifrice they were using" Comment: blind outcome assessment and use of placebo described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Overall dropout for length of follow‐up: 46.4% in 2 years. Dropout by group: 139/788 FT, 163/788 PL. Reasons for losses: children leaving school Comment: numbers lost were unduly high for the length of follow‐up. No differential losses between groups. It is unclear if reasons for missing outcome data are acceptable and balanced. Caries data used in analysis pertain to participants in complete randomised blocks at final examination |
| Selective reporting (reporting bias) | Low risk | Outcomes reported:
DMFS increment ‐ (CA) cl + (ER) xr, reported at 2 years follow‐up
stain score 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: 19.84 FT, 19.89 PL SAR: 112.42 FT, 112.58 PL DMFT: 10.39 FT, 10.39 PL Comment: initial caries appears balanced between groups |
| Free of contamination/co‐intervention? | Low risk | Quotes: "At the beginning of each month, enough dentifrice was sent for the entire family" and "All siblings were placed in the same treatment group to ensure that only one dentifrice formula was sent to a home" Comment: there is sufficient indication overall of prevention of contamination/co‐intervention |