Francetti 2004.
Methods | 2‐year follow‐up parallel group study including 2 groups with 24 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. 1‐, 2‐ and 3‐wall defects were included. Teeth with degree III mobility, necrotic, with incongruous reconstructions or under occlusal trauma were excluded. Patients should not have been treated for periodontitis in the last 3 years. Age ranging between 30 and 66; 11 males and 13 females recruited at 1 university dental clinic. | |
Interventions | Emdogain versus flap surgery. | |
Outcomes | FMPS, FMBS. For experimental teeth only: PAL, PPD, IBD on standardised intraoral radiographs at baseline, 1 and 2 years. Tooth loss, postoperative infections and adverse events. Additional intrasurgical measurements were taken. 1‐year data used. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "They were subsequently allocated to either test or control group in accordance with a 1:1 computer‐generated randomization list". |
Allocation concealment (selection bias) | Low risk | Quote: "The allocation to treatment group was concealed from clinicians until the patients received the treatment". Comment: Author informed us that the allocation to the intervention groups was concealed. During surgery, after debridement a sequentially numbered sealed opaque envelope containing the randomisation code was opened. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quotes: "It was conducted according to an open‐label, randomized parallel study protocol". "Patients were blinded as to treatment assignment throughout the study". "All radiographs were evaluated by a single examiner blind to treatment". Comment: Assessor was not blinded for the clinical outcomes due to open‐label procedure. He was blinded only for the radiographic evaluation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data are presented in Table 1: Mean values of the parameters at baseline and after 12 months and 24 months. Comment: No missing outcome data. No drop outs. |
Selective reporting (reporting bias) | Low risk | All the pre‐specified outcomes are properly presented in Table 1: Mean values of the parameters at baseline and after 12 months and 24 months. No adverse events for 1‐year data. No teeth were extracted. REC and aesthetics were not evaluated as treatment outcomes. |
Other bias | Low risk | No other source of bias can be identified. No fixed reference points were used in the radiographic assessment and therefore we decided not to use those data. |