Stookey 2004.
| Methods | Trial design: 4‐armed, double‐blind, head‐to‐head, stratified RCT Location: Puerto Rico Number of centres: not reported. Elementary schools, Puerto Rico Recruitment period: study began in/before 2001 | |
| Participants | Inclusion criteria: not reported Exclusion criteria: undergoing orthodontic therapy; extensive prosthetic appliance use Baseline caries: 8.0 DMFS (Examiner A) (Gp A: 6.84 DMFS (SD 6.33); Gp B: 8.01 DMFS (SD 7.46); Gp C: 7.26 DMFS (SD 6.79); Gp D: 7.68 DMFS (SD 6.33)). Baseline characteristic (baseline caries) "well balanced" Age at baseline (years): range 9 to 12 years, mean 10.6 years (Gp A: 10.6 years (SD 1.10); Gp B: 10.5 years (SD 1.12); Gp C: 10.6 years (SD 1.08); Gp D: 10.6 years (SD 1.14)). Baseline characteristic (age) "well balanced" Sex: Gp A: 50.8% F:49.2% M; Gp B: 51.7% F:48.3% M; Gp C: 51.9% F:48.1% M; Gp D: 48.3% F:51.7% M. Baseline characteristic (sex) '"well balanced" Any other details of important prognostic factors: background exposure to fluoride: community water supply fluoridated < 0.3 ppm F Number randomised: 955 (Gp A: 242; Gp B: 240; Gp C: 235; Gp D: 238) Number evaluated: 683 at 2 years (available at final examination) (Gp A: 168; Gp B: 174; Gp C: 180; Gp D: 160) Attrition: 29% dropout (for all study groups combined) after 2 years (study duration = 2 years). Reasons for attrition (84% of non‐completers): change of residence, withdrew, absent at final examination, fixed orthodontic appliance; no differential group losses | |
| Interventions |
Comparison: FT (4 groups)a
Gp A (n = 242): NaF 500 ppm F; abrasive system: silica; school use/supervised, twice daily
Gp B (n = 240): NaF 1100 ppm F; abrasive system: silica; school use/supervised, twice daily Gp C (n = 235): NaF 2800 ppm F; abrasive system: silica; school use/supervised, twice daily Gp D (n = 238): SnF2‐HMP 1100 ppm F; abrasive system: silica; school use/supervised, twice daily |
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| Outcomes | Primary: 2‐year DMFS increment ‐ cl (VT) + xr D2 through D4; subgroup analysis for children who attended at least 60% of supervised brushing sessions (at 1, 2 years) Secondary: none assessed Assessments irrelevant to this review's scope: n/a Follow‐up duration: 2 years | |
| Notes | Adverse effects: not reported Funding source: Procter & Gamble Company Declarations/conflicts of interest: 2 (RD Bartizek, AR Biesbrock) of 6 authors employed by Procter & Gamble. Remaining authors report institutional affiliations only Data handling by review authors: aSnF2‐HMP toothpaste group excluded from analysis (anti‐calculus agent with possible caries inhibiting action) Other information of note: clinical (VT) and radiographic assessments undertaken by 2 calibrated examiners. 50 participants re‐examined for clinical repeatability; bite‐wing films for 20 participants re‐examined for radiographic repeatability. Weighted Kappa for clinical assessment was 0.90 to 0.95; x‐ray sensitivity 97.7% to 100% and x‐ray specificity 92.6% to 95.8% Covariance analysis adjusted for age, baseline DMFS, baseline dental age, baseline surfaces at risk, dental age | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "... randomised double‐blind study" |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quotes: "... randomised double‐blind study" and "Subject and examiner blindness to treatment were maintained throughout the study" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 28.5% attrition in year 2, reasons not stated |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes (in Methods) were reported and were reported in the pre‐specified way |
| Baseline characteristics balanced? | Low risk | Quote: ".. baseline caries level ... similar amongst the four treatment groups" Comment: balance for baseline sex and caries comparable |
| Free of contamination/co‐intervention? | Low risk | Comment: siblings assigned the same toothpaste to reduce contamination but possible with home brushing |