Methods |
Randomised, parallel group study. Patients and outcome assessors blind. No withdrawals. |
Participants |
Adults. No smokers. Four immediately loaded mandibular implants. 30 enrolled and results given for 30. |
Interventions |
2 groups. 0.2% hyaluronic acid gel (Gengigel) versus 0.2% chlorhexidine gel (Elugel) applied on a toothbrush as only oral hygiene measure. Recall every 2 months. Study duration: 6 months. |
Outcomes |
Implant failure. Probing pocket depth (mm), modified plaque index (mPI) by Mombelli and modified sulcus bleeding index (mBI) by Mombelli at 10 days, 2, 4 and 6 months. 6‐month data used. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
After correspondence with the author: "The randomisation procedure was performed by allocating the patients by order of admission with the use of a pre‐determined random numbers table". |
Allocation concealment (selection bias) |
Low risk |
After correspondence with the author: "Group allocation was concealed to the investigators during the study’s data collection and analysis. The investigators only knew in which group the patients were included after the conclusion of the statistical analysis". |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
"Investigator blinding: "The patients data was separated in 2 databases with an encryption file (database 1: patients personal id and group allocation; database 2: clinical data). The investigators only knew in which group the patients were included after the conclusion of the statistical analysis". |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No loss to follow‐up. |
Selective reporting (reporting bias) |
Low risk |
|
Other bias |
Low risk |
|
Blinding of the patient? |
Low risk |
After correspondence with the author: "Patient blinding was performed by giving to the patients blank cartridges (with no information on them discriminating the product or products' characteristics"). |