Mann 2001.

Methods	Trial design: parallel (2 arms) Location: 38 settlement communities throughout Israel (type of setting not reported) Number of centres: not reported (but presumably multicentre) Recruitment period: not reported Funding source: not reported but some authors associated with Colgate (the manufacturer of the triclosan/copolymer toothpaste); "sponsor" is mentioned in the 'Materials and Methods' section but with no further information
Participants	Inclusion criteria: minimum 5 decayed or filled coronal surfaces; minimum 14 natural uncrowned teeth (excluding third molars) Exclusion criteria: orthodontic appliances involving more than 4 permanent teeth; participation in any other clinical study or test panel during the 3 months before the study began; any condition that the investigator felt would preclude their participation Baseline plaque: not reported Baseline gingivitis: not reported Baseline caries: (DFS) Gp A: mean 21.96 (SD 11.50); Gp B: mean 21.49 (SD 11.15) Age at baseline (years): Gp A: mean 45.37 (range 20‐70); Gp B: mean 45.67 (range 21‐70) Gender: Gp A: male 733 (43%), female 978 (57%); Gp B: male 754 (45%), female 927 (55%) Any other details of important prognostic factors: not reported Number randomised: not reported Number evaluated: 3392 (Gp A: 1711; Gp B: 1681)
Interventions	Comparison: triclosan/copolymer/sodium fluoride versus sodium fluoride Gp A (n = 1711 evaluated): twice daily brushing with toothpaste containing 0.3% triclosan, 2% copolymer, 0.243% sodium fluoride (no baseline prophylaxes); all participants received instruction in good oral hygiene procedures (brushing technique) from dental professionals, plus pamphlets supplied by the sponsor, plus annual mailings emphasising good oral hygiene and the importance of compliance with the study Gp B (n = 1681 evaluated): as above but without triclosan and copolymer Duration of treatment: 24 months
Outcomes	Caries (DFS mean increments), adverse effects; assessed at 12 and 24 months' follow‐up
Notes	Sample size calculation: not reported Adverse effects: none observed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "...randomly assigned" Comment: insufficient information on the method of sequence generation Additional information from correspondence: "random sequence generators were used"
Allocation concealment (selection bias)	Low risk	Quote: "...randomly assigned" Comment: not mentioned Additional information from correspondence: a rigorous allocation procedure was carried out by people not involved in the study and we are satisfied that this was properly concealed from those involved in the study
Blinding of participants (performance bias) All outcomes	Low risk	Quote: "double‐blind" and "Dentifrice tubes were covered with white overwrap to mask the identity of the product. When new tubes of the dentifrice were delivered, subjects returned their previous tubes so that compliance with dentifrice use could be monitored" Comment: participants did not know which group they were assigned to
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double‐blind" Comment: the examiner did not know which group the participants they were assessing had been assigned to
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The authors did not report the initial number of participants randomised; they only reported the number analysed. Attrition (if there was any) was not reported by group and reasons were not given
Selective reporting (reporting bias)	Low risk	For a study looking into anticaries effect, we believe that appropriate outcome measures were considered and reported in full
Other bias	Low risk	Quote: "Dental caries was scored by two trained and calibrated examiners" and "The Kappa Statistic for inter‐ and intra‐examiner reproducibility of caries scores was greater than 0.9, indicating a high level of agreement within and between the two examiners" Comment: we consider that the risk of differential diagnostic activity was low. We were unable to identify any other potential source of bias