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. 2009 Oct 7;2009(4):CD003875. doi: 10.1002/14651858.CD003875.pub3

Rösing 2005.

Methods 1‐year follow‐up split‐mouth study including 16 patients.
Participants Patients in good general health and motivated for good oral hygiene. Teeth with IBD greater or equal to 3 mm and wider than 2 mm on intraoral radiographs. Age ranging between 29‐54; patients recruited in 1 university dental clinic.
Interventions Emdogain versus flap surgery and placebo.
Outcomes FMPS and FMBS. For experimental teeth only: BOP, PAL, PPD, IBD on standardised intraoral radiographs at baseline, 6 months, and 1 year. 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: "Then, by means of the flip of a coin, the experimental (EMD) and the placebo (both provided by the manufacturer) solutions were applied in accordance to the instructions".
Allocation concealment (selection bias) Low risk Quote: "The present study was carried out according to a typical double‐masked, split‐mouth design, with the codes kept by the manufacturer until the data had been collected and organised in the computer program for statistical analysis".
Author's reply: "Randomization of the site was decided with the flip of a coin after debridement of both sites and application of the EDTA solution".
Blinding (performance bias and detection bias) 
 All outcomes Low risk Quote: "Analysis of the radiographic outcomes were performed using computerized linear measurements from the cemento‐enamel junction (CEJ) to the bone crest (BC), CEJ to the bottom of the defect (BD), and BC to BD by an examiner masked to time and treatment. All clinical and radiographic measurements were performed according to a double‐masked protocol".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcome data are presented in Tables 1 and 3.
Comment: No missing data. Drop outs are explained adequately.
Selective reporting (reporting bias) Low risk All pre‐specified outcomes for PPD, PAL and IBD are reported in Tables 1 and 3.
2 teeth were extracted. No adverse events were noted. REC and aesthetics were not evaluated as treatment outcomes.
Other bias Low risk Although EMD and placebo materials were provided by the manufacturer, this was an independently conducted study.