Cubells 1991.

Methods	Trial design: parallel (2 arms) Location: "clinical facility", Barcelona, Spain Number of centres: 1 Recruitment period: not reported Funding source: not reported but some authors associated with Colgate (the manufacturer of the triclosan/copolymer toothpaste)
Participants	Inclusion criteria: healthy adults; mean baseline modified Quigley‐Hein Plaque Index score of 1.5 or more and mean baseline modified Löe‐Silness Gingival Index score of 1.0 or more Exclusion criteria: not reported Baseline plaque: (Quigley‐Hein Plaque Index) Gp A: mean 2.842; Gp B: mean 2.857; (Plaque Severity Index) Gp A: mean 0.617 (SD 0.164); Gp B: mean 0.617 (SD 0.151) Baseline gingivitis: (Löe‐Silness Gingival Index) Gp A: mean 1.406; Gp B: mean 1.405; (Gingivitis Severity Index) Gp A: mean 0.368 (SD 0.172); Gp B: mean 0.373 (SD 0.171) Baseline caries: not reported Age at baseline (years): Gp A: mean 24.3 (range 18‐57); Gp B: mean 22.4 (range 18‐57) Gender: Gp A: male 22 (39%), female 34 (61%); Gp B: male 23 (44%), female 29 (56%) Any other details of important prognostic factors: not reported Number randomised: 120 (not reported by group) Number evaluated: 108 (Gp A: 56; Gp B: 52)
Interventions	Comparison: triclosan/copolymer/sodium fluoride versus sodium fluoride Gp A (n = 56 evaluated): twice daily brushing for 1 minute with toothpaste containing 0.3% triclosan, 2% copolymer, 0.243% sodium fluoride; all participants received thorough baseline oral prophylaxis (removal of all subgingival and supragingival plaque and calculus deposits), teeth were polished and erythrosin was used to confirm complete plaque removal; participants had to visit the clinical facility every 4 weeks to exchange their used toothpaste tube and toothbrush for a new supply Gp B (n = 52 evaluated): as above but without triclosan and copolymer Duration of treatment: 6 months
Outcomes	Plaque (Quigley‐Hein Plaque Index and Plaque Severity Index), gingivitis (Löe‐Silness Gingival Index and Gingivitis Severity Index), adverse effects; assessed at 1.5 and 6 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: simple randomisation using random number tables
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 "The dentifrices were distributed to the subjects in identical plain white tubes to ensure that neither the subjects nor the dental examiners knew the identity of the products" Comment: use of an identical control toothpaste meant that participants did not know which group they were assigned to
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double‐blind" and "The dentifrices were distributed to the subjects in identical plain white tubes to ensure that neither the subjects nor the dental examiners knew the identity of the products" Comment: the examiner did not know which group the participants they were assessing had been assigned to
Incomplete outcome data (attrition bias) All outcomes	Low risk	10% of randomised participants were not included in the final analysis. Attrition was not reported by group and reasons were not given, but authors stated that reasons were not related to the use of either of the toothpastes Comment: we do not believe that any of the above could pose a risk of bias significant enough to have led to a distortion of the true intervention effect
Selective reporting (reporting bias)	Low risk	Appropriate outcome measures were considered and reported in full, as described in the methods section
Other bias	Low risk	Quote: "The intrarater reliability coefficient was found to be 0.85" Comment: we consider that the risk of differential diagnostic activity is low. We were unable to identify any other potential source of bias