Mateu 2008.

Methods	Trial design: parallel (2 arms) Location: "clinical facility", Barcelona, Spain Number of centres: 1 Recruitment period: not reported Funding source: "This study was supported by the Colgate‐Palmolive Company"
Participants	Inclusion criteria: healthy adults; minimum 20 uncrowned permanent natural teeth (excluding third molars); mean baseline modified Quigley‐Hein Plaque Index score of 1.5 or more and mean baseline Löe‐Silness Gingival Index score of 1.0 or more Exclusion criteria: wearing orthodontic appliances; wearing partial removable prostheses; tumours of the oral soft or hard tissues; advanced periodontal disease (purulent exudates, tooth mobility, extensive periodontal attachment loss or alveolar bone loss, or a combination of these); 5 or more carious lesions requiring immediate restorative treatment; history of allergy to personal care/consumer products or their ingredients; any medical condition precluding participants from not eating and drinking for periods up to 4 hours; use of any prescription medication that might interfere with the study outcomes; pregnant or lactating women; use of antibiotics during the 1 month before the study began; participation in any other clinical study or test panel during the 1 month before the study began; received a dental prophylaxis during the 2 weeks before the study began Baseline plaque: (Quigley‐Hein Plaque Index) Gp A: mean 3.19 (SD 0.52); Gp B: mean 3.23 (SD 0.53); (Plaque Severity Index) Gp A: mean 0.66 (SD 0.12); Gp B: mean 0.67 (SD 0.11) Baseline gingivitis: (Löe‐Silness Gingival Index) Gp A: mean 1.39 (SD 0.27); Gp B: mean 1.39 (SD 0.23); (Gingivitis Severity Index) Gp A: mean 0.37 (SD 0.21); Gp B: mean 0.38 (SD 0.18) Baseline caries: not reported Age at baseline (years): Gp A: mean 35.9 (range 22‐58); Gp B: mean 37.2 (range 21‐72) Gender: Gp A: male 13 (27%), female 35 (73%); Gp B: male 15 (33%), female 31 (67%) Any other details of important prognostic factors: not reported Number randomised: not reported Number evaluated: 94 (Gp A: 48; Gp B: 46)
Interventions	Comparison: triclosan/copolymer/sodium fluoride versus sodium fluoride Gp A (n = 48 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; asked to refrain from all oral hygiene procedures for at least 12 hours and from eating, drinking or smoking for 4 hours before their baseline and follow‐up examinations Gp B (n = 46 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 3 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: "...randomized into two treatment groups" 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: "...randomized into two treatment groups" 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 "All dentifrices were over‐wrapped in their original package" 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	Appropriate outcome measures were considered and reported in full, as described in the methods section
Other bias	Low risk	No mention of calibration of outcome assessor so it is unclear whether or not there was a risk of differential diagnostic activity Additional information from correspondence: this study followed a protocol whereby all outcome assessors were highly trained in the indices and procedures used, and inter‐ and intra‐examiner calibration occur where practical. Therefore, we consider that the risk of differential diagnostic activity is low. We were unable to identify any other potential source of bias