Methods |
Randomised, split‐mouth study. Patients cannot be blind, outcome assessor not blind. No withdrawals. |
Participants |
Adults. Four mandibular implants splinted with a bar supporting an overdenture. 16 enrolled and results given for 16. |
Interventions |
2 groups. Monthly 35% phosphoric etching gel (pH1) for 1 minute versus supra‐ and sub‐gingival mechanical debridement using carbon fibre curettes and rubber cup. Maintenance every month. Study duration: 5 months. |
Outcomes |
Plaque index by Silness and Loe, calculus index by Bjorby and Loe, a modification of the gingival index by Loe and Silness, change in probing pocket depth (mm), microbiological sampling, postoperative pain and treatment time at 1 and 5 months. 5‐month data used. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Test and control therapy was randomly assigned to left and right sides of the mandible". Written to the author: "We used a cobblestone, even numbers was the right test side of the patient, uneven the left". |
Allocation concealment (selection bias) |
Unclear risk |
"Test and control therapy was randomly assigned to left and right sides of the mandible". |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
"Test and control site were then revealed to the same examiner, who performed the assigned treatments and follow‐up measurements throughout the study". |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No withdrawals. No reply from author. |
Selective reporting (reporting bias) |
Unclear risk |
No reply from author. |
Other bias |
Unclear risk |
No reply from author. |
Blinding of the patient? |
Low risk |
Not possible. This was judged to be irrelevant for the risk assessment. |