Pradeep 2012.

Methods	Trial design: parallel (3 arms) Location: Department of Periodontics, Government Dental College and Research Institute, Bangalore, India Number of centres: 1 Recruitment period: not reported Funding source: not reported but the toothpastes were provided by LB Aroma and Health Care, Mumbai, India
Participants	Inclusion criteria: diagnosis of chronic generalised gingivitis; minimum 20 natural teeth; bleeding on gentle probing at more than 30% of sites examined and mean baseline Löe‐Silness Gingival Index score of 1.0 or more at more than 60% of sites examined; pocket probing depth of 3 mm or less; no clinical attachment loss; mean baseline modified Quigley‐Hein Plaque Index score of more than 2.0; no evidence of radiographic bone loss Exclusion criteria: received periodontal therapy or used antibiotics or anti‐inflammatory medication during the 6 months before the study began; known allergy to any of the toothpaste ingredients; haematological disorders or other systemic illness; pregnant or lactating women; receiving orthodontic treatment; smokers Baseline plaque: (Quigley‐Hein Plaque Index) Gp A: mean 4.369 (SD 0.595); Gp B: mean 4.436 (SD 0.704) Baseline gingivitis: (Löe‐Silness Gingival Index) Gp A: mean 1.963 (SD 0.4); Gp B: mean 1.934 (SD 0.368) Baseline caries: not reported Age at baseline (years): Gp A: mean 29.4; Gp B: mean 30.4 (range not reported) Gender: Gp A: male 13 (46%), female 15 (54%); Gp B: male 14 (50%), female 14 (50%) Any other details of important prognostic factors: not reported Number randomised: 60 (Gp A: 30; Gp B: 30) Number evaluated: 56 (Gp A: 28; Gp B: 28)
Interventions	Comparison: aloe vera* versus triclosan/copolymer/fluoride versus placebo (sodium fluoride not stated) *We excluded this arm from our data extraction, risk of bias assessment and analyses Gp A (n = 30): brushing with toothpaste (frequency not reported, i.e. normal use) containing triclosan, copolymer, fluoride (concentrations not stated); all participants received thorough baseline oral prophylaxis (removal of all supragingival plaque and calculus deposits) plus instruction/demonstration of the modified Bass method of brushing; asked to refrain from all oral hygiene procedures (including chewing gum) for at least 8 hours before their baseline and follow‐up examinations; asked to refrain from any other oral hygiene procedures during the study period Gp B (n = 30): as above but with placebo toothpaste Duration of treatment: 6 months
Outcomes	Plaque (Quigley‐Hein Plaque Index), gingivitis (Löe‐Silness Gingival Index), microbial counts, adverse effects; assessed at 1.5, 3 and 6 months' follow‐up
Notes	Sample size calculation: sample size was decided by power analysis with 90% power at a 5% significance level but it is not clear if the required sample size was achieved after attrition Adverse effects: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "...participants were assigned randomly by a computer‐generated numbering sequence" Comment: this is the ideal way to generate a random sequence
Allocation concealment (selection bias)	Low risk	Quote: "The dentifrices were dispensed to patients by a dental assistant not involved in the study" Comment: this is similar to remote/centralised allocation and the study investigators would not be able to influence the allocation sequence
Blinding of participants (performance bias) All outcomes	Low risk	Quote: "double‐masked" and "All tubes had a plain white covering labelled only with lot numbers to ensure proper masking of the product from the patients and examiner" Comment: participants did not know which group they were assigned to
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double‐masked" and "All tubes had a plain white covering labelled only with lot numbers to ensure proper masking of the product from the patients and examiner" 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	Only 7% of randomised participants were not included in the final analysis (Gp A: 7%; Gp B: 7%). Reasons for attrition were discussed 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)	High risk	Appropriate outcome measures were considered but adverse effects were not reported in the results 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