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

Marthaler 1970a.

Methods Random allocation; indication of blind caries assessment (C); placebo‐controlled; 30% drop out (for all study groups combined) after 4 years (study duration = 4 years). Exclusions based on: use of orthodontic bands, and presence in all follow‐up examinations; any differential group losses not assessable.
Participants 43 children analysed at 4* years (present for all examinations).
 Age range at start: 7‐9 years (average = 8).
 Surfaces affected at start: 2.3 DMFS.
 Background exposure to fluoride: salt (suboptimal).
 Year study began: 1966.
 Location: Switzerland.
Interventions FT versus PL 
 (AmF group = 1250 ppm F).
Home use/unsupervised, twice/three times a day/800 times a year estimated.
 Abrasive system: IMP.
Outcomes 2y*NetDFS increment ‐ (CA)cl+(DR)xr.
 Reported at 2 and 4 years follow ups.
1stmPF‐DFS. 
 1stmMD‐DFS.
Notes Participants randomised (numbers for relevant groups NR).
 Baseline characteristics (age, DMFS, 1stmDMFS) 'balanced' (DFS baseline data NR).
 Clinical (V) caries assessment by two examiners; diagnostic threshold = CA and NCA; state of tooth eruption included NR. Radiographic assessment (2 postBW) by two examiners; diagnostic threshold = DR and ER; partial recording. "Sufficient agreement of examiners known from earlier work".
 *F solution used by all children after 2 years (final 4 years results not considered).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
HHS Vulnerability Disclosure