Kraivaphan 2006.

Methods	Trial design: parallel (2 arms) Location: antenatal care unit, Taksin Hospital, Bangkok, Thailand Number of centres: 1 Recruitment period: not reported Funding source: not reported
Participants	Inclusion criteria: healthy pregnant women (3 months' gestation); mean baseline modified Löe‐Silness Gingival Index score of 1.0 or more Exclusion criteria: not reported Baseline plaque: not reported Baseline gingivitis: (Löe‐Silness Gingival Index) Gp A: mean 1.778 (SD 0.432); Gp B: mean 1.797 (SD 0.432) Baseline caries: not reported Age at baseline (years): Gp A: mean 27 (range 19‐37); Gp B: mean 26 (range 19‐40) Gender: not applicable Any other details of important prognostic factors: it is important to stress that the main factor differentiating this study population from others included in the review is that they were pregnant women Number randomised: 140 (not reported by group) Number evaluated: 120 (Gp A: 60; Gp B: 60)
Interventions	Comparison: triclosan/copolymer (sodium fluoride not stated) versus placebo (sodium fluoride not stated) Gp A (n = 60 evaluated): twice daily brushing for 1 minute with toothpaste containing 0.3% triclosan, 2% copolymer; all participants received thorough baseline oral prophylaxis (removal of all subgingival and supragingival plaque and calculus deposits) Gp B (n = 60 evaluated): as above but with placebo toothpaste Duration of treatment: 9 months (including 3 months' postpartum use)
Outcomes	Gingivitis (Löe‐Silness Gingival Index); assessed at 3, 5 and 9 months' follow‐up
Notes	Sample size calculation: not reported Adverse effects: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "...randomly assigned" Comment: insufficient information on the method of sequence generation
Allocation concealment (selection bias)	Unclear risk	Quote: "...randomly assigned" Comment: not mentioned
Blinding of participants (performance bias) All outcomes	Low risk	Quote: "double‐blind" 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	14% 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. However, if the missing participants had higher mean gingivitis scores in one group than the other, as the attrition rate increased, so would over/understatement of the mean difference
Selective reporting (reporting bias)	Low risk	Appropriate outcome measure considered and reported in full, as described in the methods section
Other bias	Unclear risk	No mention of calibration of outcome assessor so it is unclear whether or not there was a risk of differential diagnostic activity