Methods |
Randomised, parallel group study. Patients cannot be blind, outcome assessor blind. No withdrawals. |
Participants |
Adults. Age 35 to 75. 24 enrolled and results given for 24. |
Interventions |
2 groups. Antiseptic subgingival irrigation (100 ml chlorhexidine 0.06%) once per day versus rinsing (20 ml chlorhexidine 0.12) once daily. Study duration: 3 months. |
Outcomes |
Turesky modification of Quigley‐Hein plaque index, a modification of the Ainamo and Bay bleeding index, Lobene Stain Index (no SD were given so it could not be used) at 3 months. |
Notes |
The article reported that 2 ml of chlorhexidine (0.12%) was used. The authors replied that it was a print mistake and that a quantity of 20 ml was used.
The Ainamo and Bay bleeding index was recorded using a "sweeping motion" and not with a "gentle probing".
Trial described as double‐blind, but two different procedures were used. The author replied that the patients did not know if they got a placebo mouthrinse or chlorhexidine. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Subjects were randomly assigned by a computer‐generated random code to one of two groups". |
Allocation concealment (selection bias) |
Low risk |
"Subjects were randomly assigned by a computer‐generated random code to one of two groups". |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
"One trained examiner blinded to the subjects' assignment of mouthrinse or irrigation performed all the measurements". |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All data reported. No loss to follow‐up. |
Selective reporting (reporting bias) |
Low risk |
All data reported. |
Other bias |
Unclear risk |
The study was partly supported by grants from Colgate Oral Pharmaceuticals and Teledyn Water Pik. |
Blinding of the patient? |
Low risk |
Written to the authors. Replied that the patients do not know if they got a placebo mouthrinse or chlorhexidine. |