Rao 2009.

Methods	Trial design: 3‐armed, triple‐blind, placebo‐controlled, stratified RCT Location: India Number of centres: 2 schools, Bangalore, India Recruitment period: study began 2004
Participants	Inclusion criteria: healthy; high caries risk + previous caries experience (dmft/DMFT > 2) + deep pits/fissures; poor oral hygiene; low socio‐economic status Exclusion criteria: illness; caries risk‐antagonist medication use; severe malocclusion; current orthodontic treatment; dental hypoplasia presence; consent refusal Baseline caries: 2.42 DMFS (groups relevant to review: Gp A: 2.20 DMFS (SD 2.57); Gp B: 2.62 DMFS (SD 2.62)) (evaluated participants only). Baseline characteristics similar (DMFS, proportion caries free, oral hygiene) Age at baseline (years): range 12 to 15 years, mean 13.4 years (groups relevant to review: Gp A: mean 13.46 years (SD 0.89); Gp B: mean 13.48 years (SD 0.86)) (evaluated participants only). Baseline characteristic similar (age) Sex: 73 F:77 M (groups relevant to review: Gp A: 22 F:25 M; Gp B: 21 F:24 M) (evaluated participants only) Any other details of important prognostic factors: background exposure to fluoride: not reported Number randomised: 150 (groups relevant to review: Gp A: 50; Gp B: 50) Number evaluated: 139 at 2 years (available at final examination) (groups relevant to review: Gp A: 47; Gp B: 45) Attrition: 8% dropout after 2 years (study duration = 2 years). Reason for dropout given as change to school and thus no longer eligible. No differential group losses
Interventions	Comparison: FT, CPP versus PL Gp A (n = 50): SMFP 1000 ppm F; abrasive system: Ca carbonate; home use (unsupervised) and school use (supervised), twice daily Gp B (n = 50): placebo; abrasive system: Ca carbonate; home use (unsupervised) and school use (supervised), twice daily Gp C (n = 50): CPP; abrasive system: Ca carbonate; home use (unsupervised) and school use (supervised), twice daily
Outcomes	Primary: 2‐year DS increment ‐ (CA) cl; DMFS; DS; number of new lesions (at 1, 2 years) Secondary: adverse events Assessments irrelevant to this review's scope: OHI; compliance Follow‐up duration: 2 years
Notes	Adverse effects: "There were no incidents of allergy or any adverse reactions" Funding source: not reported Declarations/conflicts of interest: not reported Data handling by review authors: Gp C (CPP) omitted from analysis Other information of note: participants at high caries risk with previous caries dmft/DMFT > 2, poor oral hygiene and low socio‐economic status. Clinical (VT) caries assessment by 1 examiner according to WHO criteria, diagnostic threshold not stated, CA assumed. No radiographic assessment. Intra‐ examiner reproducibility of clinical caries diagnosis (DMFS) assessed in 20 children. Kappa 0.74 to 0.85
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The 150 selected subjects were first stratified according to age. From each age group subjects were randomly allocated to three groups of 50 by shuffling and picking the chits containing the subjects' names" Comment: random sequence generation stated
Allocation concealment (selection bias)	Unclear risk	No information provided
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quotes: "The toothpastes prepared as below were coded by coloring the toothpaste tubes red, green or black, to ensure blinding of the investigator, the subjects and the statistician" and "All three types of toothpaste were similar in consistency, color and flavor to avoid any bias" Comment: investigators and participants blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "11 children dropped out since they changed to nonparticipating schools after 1 year and were not available for the 24‐month follow‐up" Comment: overall dropout for length of follow‐up: 7% in 2 years. No differential dropout. Reasons for losses stated. Caries data used in analysis pertain to participants present at final examination
Selective reporting (reporting bias)	Unclear risk	Outcomes reported: DS increment ‐ (CA) cl, reported at 1 and 2 years follow‐ups DS OHI compliance adverse events Comment: trial protocol not available. Not all outcomes listed in Methods section were reported (DMFS)
Baseline characteristics balanced?	Unclear risk	Prognostic factors reported: age, sex, caries, OHI Comment: all appear balanced
Free of contamination/co‐intervention?	Unclear risk	Quote: "There were no cases of exchange of toothpaste tubes since the color of the toothpaste tube was cross‐ checked against the assigned color" Comment: contamination not observed