Di Maggio 1980.
| Methods | Trial design: 2‐armed, double‐blind, placebo‐controlled RCT Location: Italy Number of centres: not reported Recruitment period: study commenced in/before 1977 | |
| Participants | Inclusion criteria: age between 11 and 12 years and resident at the orphanage
Exclusion criteria: not reported
Baseline caries: 11.7 DMFS (Gp A: 11.50 DMFS/5.68 DMFT; Gp B: 11.85 DMFS/5.90 DMFT) (evaluated participants at 2 years reported only). Baseline characteristics (DMFS, DMFT) '"balanced" Age at baseline (years): range 11 to 12 years (mean, or by group not reported) Sex: not reported Any other details of important prognostic factors: data unavailable for site fluoridation status Number randomised: 50 (group distribution unreported) Number evaluated: 42 (present at final assessment. Gp A: 22; Gp B: 20) Attrition: 16% dropout (for both study groups combined) after 2 years. Main reason for attrition described: left institution; any differential group losses not assessable |
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| Interventions | Comparison: FT versus PL Gp A (n = evaluated 22): SMFP‐NaF 2500 ppm F; abrasive system not clearly specified; Iinstitution use/supervised, 3 times a day Gp B (n = evaluated 20): placebo; abrasive system not clearly specified; institution use/supervised, 3 times a day | |
| Outcomes | Primary: 2‐year DMFS increment ‐ cl; DMFT (at 1 and 2 years follow‐up) Secondary: none assessed Assessments irrelevant to this review's scope: none Follow‐up duration: 2 years | |
| Notes | Adverse effects: not reported Funding source: not reported Declarations/conflicts of interest: not reported Data handling by review authors: n/a Other information of note: clinical caries assessment by 2 examiners; diagnostic threshold not reported; state of tooth eruption included not reported. Diagnostic errors not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "... following a randomisation list the children were allocated to 2 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: "...to 2 treatment groups that differed only by the presence or absence of fluoride. ...the dentifrices were indistinguishable by colour or flavour" and "...using the most strict double‐blind condition" 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: 16% (8/50) in 2 years. Dropout by group: not reported. Reasons for losses: essentially due to leaving the orphanage Comment: numbers lost were not unduly high for the length of follow‐up. It is unclear if there were any differential losses, and if reasons for missing outcome data are acceptable and balanced. Caries data used in analysis pertain to participants present at final examinations |
| Selective reporting (reporting bias) | Low risk | Outcomes reported:
DMFS increment ‐ cl, reported at 1 and 2 years follow‐ups
DMFT Comment: trial protocol not available. All pre‐specified outcomes were reported and were reported in the pre‐specified way |
| Baseline characteristics balanced? | Low risk | Prognostic factors reported:
DMFT: 5.68 FT, 5.90 PL DMFS: 11.50 FT, 11.85 PL Comment: initial caries appears balanced |
| Free of contamination/co‐intervention? | Low risk | Quote: "The institute personnel actively collaborated in controlling the regular dentifrice use, as prescribed" Comment: there is sufficient indication overall of prevention of contamination/co‐intervention |