Silvestri 2000.
Methods | 1‐year follow‐up parallel‐group study including 3 groups with 30 patients in total. No drop outs at 1 year. | |
Participants | Patients in good general health and motivated for good oral hygiene. Teeth with PPD greater or equal to 6 mm and IBD greater or equal to 4 mm. Smokers were excluded. Age ranging between 37 and 59; 11 males and 19 females recruited in 1 university dental clinic and several private practices. | |
Interventions | Emdogain versus GTR with Gore‐Tex non‐resorbable barriers versus flap surgery. | |
Outcomes | FMPS and FMBS. For experimental teeth only: PAL, PPD, REC at baseline and 1 year. Tooth loss and postoperative infections. 1‐year data used. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Once the patients met on all entry criteria, they were randomly (Fleiss 1992) assigned to 1 of 3 surgical procedures". |
Allocation concealment (selection bias) | High risk | Author informed us that group allocation was not concealed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Author informed us that no blinding method was used. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data for PAL, PPD and REC are presented in Table 1. Comment: No missing data. No drop outs. |
Selective reporting (reporting bias) | Low risk | All the pre‐specified outcomes are reported in Table 1. No teeth were extracted. Aesthetics and changes in bone level were not evaluated. |
Other bias | Unclear risk | Manufacturers partially supported the trial by offering free materials. We do not think that this has affected the outcome of the trial. Connective tissue grafts were placed in 6 patients after membrane removal. We are unsure whether this affected the outcome of the trial. |