| Methods | Randomised, parallel group study. Patients and outcome assessors blind. One withdrawal due to reason unrelated to the trial from the Sodium Fluoride group. | |
| Participants | Adults. Age 30 to 60 years. 60 enrolled, results given for 59. | |
| Interventions | Brushing with a dentifrice containing 0.3% triclosan and 2.0% PVm/MA copolymer in a sodium fluoride silica base (Colgate® Total® Toothpaste, Colgate‐Palmolive Company, New York, NY, USA) versus brushing with a dentifrice containing 0.243 sodium fluoride in a silica base (Colgate® Cavity Protection® Toothpaste, Colgate‐Palmolive Company, New York, NY, USA). A soft‐bristled toothbrush was supplied. Study duration: 6 months. | |
| Outcomes | PPD, BOP, plaque (presence/absence): data recorded at 3 and 6 months. 6 months data used. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The subjects were randomly assigned to two treatment groups." |
| Allocation concealment (selection bias) | Low risk | "Personnel who did not take active part in the clinical examinations carried out the allocation of dentifrices according to the randomisation." |
| Blinding (performance bias and detection bias) All outcomes | Low risk | "The dentifrices were supplied in their original tubes, but over wrapped with a white label and coded so as to ensure that neither the examiner nor the participants were aware of the identity of the product." |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No reply from author. One loss to follow‐up. |
| Selective reporting (reporting bias) | Unclear risk | No reply from author. |
| Other bias | Unclear risk | "This study was supported by the Colgate‐Palmolive Company". |
| Blinding of the patient? | Low risk | "The dentifrices were supplied in their original tubes, but over wrapped with a white label and coded so as to ensure that neither the examiner nor the participants were aware of the identity of the product." |