Tonetti 2002.
Methods | 1‐year follow‐up parallel‐group study including 2 groups with 172 patients in total. 6 drop outs at 1 year. 3 patients withdrew consent before surgery. 3 patients (2 from the test and 1 from the control group) were unable to comply with the follow up for reasons independent from the treatments. | |
Participants | Patients in good general health and motivated for good oral hygiene. Teeth with IBD greater or equal to 3 mm in presence of 2 to 3 mm of keratinized gingiva on the buccal aspect. Heavy smokers (> 20 cigarettes per day) were excluded. 1‐, 2‐ and 3‐wall defects were included. Age ranging between 39 and 57; females were 54.2% in the test and 60.2% in the control groups. Patients were recruited both from university dental clinics and private practices. | |
Interventions | Emdogain versus flap surgery. | |
Outcomes | FMPS and FMBS. For experimental teeth only: PAL, PPD, REC at baseline and 1 year. Tooth loss and postoperative infections. Additional intrasurgical measurements were taken. 1‐year data used. Postoperative morbidity, patient satisfaction, aesthetics and several other patient‐centred outcomes were evaluated. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "All subjects were assigned a patient number, and were randomly assigned to one of the two treatment regiments. Assignment was performed by a central randomization facility using a custom‐made program based on balanced random permuted blocks". |
Allocation concealment (selection bias) | Low risk | Author informed us that the allocation to the intervention groups was concealed. During surgery, after debridement, a sealed opaque envelope containing the randomisation code was opened. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "In each center, the examiner and the therapist were identical". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data are presented in Table 2: Clinical outcomes at 1 year. Comment: No missing data. Drop outs are explained adequately. |
Selective reporting (reporting bias) | Low risk | All the pre‐specified outcomes are reported in Table 2: Clinical outcomes at 1 year. No teeth were extracted. No infectious complications were observed. The aesthetics evaluation was reported in Tonetti et al 2004 JCP 31:1092‐8. Changes in bone level were not assessed. |
Other bias | Low risk | The trial was partially supported with a research grant from the manufacturer. We do not think that this has affected the outcome of the trial. |