Methods | Randomised, parallel group study. Patients and outcome assessors blind. 3 withdrawals at 1 year (2 in the AmF/SnF2; 1 in the CHX group), none at 3 months. | |
Participants | Adults. Age 34 to 79 years. One‐stage implants. 33 enrolled and results given for 33 at 3 months, 30 at 1 year. | |
Interventions | 2 groups. Amine fluoride/stannous fluoride mouthwash (10 ml) twice per day for 60 seconds versus chlorhexidine mouthwash following toothbrushing for 3 months. Recall first and third month. Study duration: 12 months (data at 3 months). | |
Outcomes | Implant failure, bone width, bone to implant distance, radiographic bone height (3 and 12 months), staining index, patient compliance. Patient subjective evaluation questionnaire (visual analog scale): taste, change in taste, desire for future use, overall satisfaction at 3 months. 3‐month data used. | |
Notes | 36 packages were randomised, but 33 patients enrolled. Mouthrinses used for 3 months after 1‐stage surgery. No indication on plaque and mucosal inflammation parameters. Radiographic data and bone data at implant level. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer randomisation was done before commencement of the study by assigning either CHX or AmF/SnF2 to unmarked packages numbered 1 to 36". |
Allocation concealment (selection bias) | Low risk | "De‐coding of the mouthwashes was performed only after the completion of all data acquisition and termination of the study". |
Blinding (performance bias and detection bias) All outcomes | Low risk | "De‐coding of the mouthwashes was performed only after the completion of all data acquisition and termination of the study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss at follow‐up at 3 months when date were taken. |
Selective reporting (reporting bias) | Unclear risk | Important variables related to plaque or mucosal inflammation parameters are missing. |
Other bias | Unclear risk | This study was partially supported by a grant from GABA International, Ltd, Munchestein, Switzerland. Bone data and data on radiographic bone level given at implant level. Written but not possible to have data at patient level. |
Blinding of the patient? | Low risk | "Computer randomisation was done before commencement of the study by assigning either CHX or AmF/SnF2 to unmarked packages numbered 1 to 36". |