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. 2003 Jan 20;2003(1):CD002278. doi: 10.1002/14651858.CD002278

Abrams 1980.

Methods Stratified random allocation; double‐blind (A); placebo‐controlled; 48% drop out after 3 years (study duration = 3 years). Reasons for high drop out described: change of residence, absenteeism, non‐adherence to study protocol; no differential group losses.
Participants 1141 children analysed at 3 years (available at final examination).
 Age range at start: 5‐12 years. Surfaces affected at start: 3.2 DFS. Background exposure to fluoride: none reported.
 Year study began: in/before 1976.
 Location: USA.
Interventions FT (2 groups) versus PL 
 (both SnF2 groups = 1000 ppm F).
Home use/unsupervised, daily frequency assumed.
 Abrasive system: silica gel in one SnF2 and placebo toothpaste, Ca pyrophosphate in the other SnF2 toothpaste.
Outcomes 3yNetDFS increment ‐ (E+U) (CA)cl+(ER)xr.
 Reported at 1, 2 and 3 years follow ups.
DMFT.
 DMFS.
 DFT.
 MD‐DFS.
 DFT rate.
 DFS rate.
Notes Participants randomised (N = 2210).
 Baseline characteristics (DFS) 'balanced' .
 Clinical (VT) caries assessment by two examiners, diagnostic threshold = CA. Radiographic assessment (postBW) by two 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 (% of times diagnosis replicated in all 3 examinations ranged 42‐97% and 77‐ 92% for both examiners and for each respectively).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure