CL‐216 1982.
| Methods | Trial design: 2‐armed, double‐blind, active‐controlled and stratified RCT Location: Oregon, USA Number of centres: not stated Recruitment period: study commenced in 1980 | |
| Participants | Inclusion criteria: male and female schoolchildren in Grades 1 to 5
Exclusion criteria: schoolchildren with a condition which prohibited a thorough oral examination, including orthodontic therapy and extensive prosthetic appliances
Baseline caries: not reported Age at baseline (years): range 6 to 10 years Sex: not reported Any other details of important prognostic factors: background exposure to fluoride not reported. Community water supply fluoride < 0.3 ppm Number randomised: not reported Number evaluated: 2758 at 2 years (present for final assessment. Gp A: 1371; Gp B: 1387) Attrition: unable to calculate due to missing information from number randomised |
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| Interventions | Comparison: FT versus FT Gp A (n = 1371 evaluated): NaF 1100 ppm F; abrasive system not reported; home use ad libitum (twice daily, unsupervised assumed) Gp B (n = 1387 evaluated): NaF 1700 ppm F; abrasive system not reported; home use ad libitum (twice daily, unsupervised assumed) | |
| Outcomes | Primary: 2‐year DMFS increment ‐ cl + xr Secondary: none reported Assessments irrelevant to this review's scope: none Follow‐up duration: 2 years | |
| Notes | Adverse effects: not reported Funding source: The Procter & Gamble Company Declarations/conflicts of interest: none reported. Procter & Gamble data Data handling by review authors: n/a Other information of note: all clinical (Radike criteria) and radiographic examinations were carried out by a single examiner. Study "...was terminated following the Year 2 examinations." "Per the study protocols, Studies A and B were each designed to cover a period of two to three years, so collecting Year 3 data for a subset of subjects or omitting the Year 3 examinations were actions within the scope of the protocols." Unpublished data on file from The Procter & Gamble Company, published in Bartizek 2001 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...subjects were stratified based on gender, age and baseline DMFS scores derived from the visual‐tactile examination, and randomly assigned to one of the treatment groups in the study" |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quotes: "... double‐blind study" "Subject and examiner blindness to treatment were maintained throughout the study" and "Dentifrices were supplied in plain white tubes" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "The studies each enrolled approximately 1200 to 2000 male and female schoolchildren per treatment group" Comment: actual number randomised not reported, so unable to calculate attrition |
| Selective reporting (reporting bias) | Low risk | Comment: results reported traditional increment using clinical and radiographic assessments |
| Baseline characteristics balanced? | Low risk | Comment: not explicitly stated, but stratified randomisation according to gender, age and baseline DMFS scores with large sample size so probably balanced |
| Free of contamination/co‐intervention? | Low risk | Quote: "...siblings, all were automatically assigned to the same treatment group as the first sibling to minimise the risk from cross‐usage of assigned dentifrice" |