Reconstructive Surgical Treatment of Peri-implant Intra-osseous Defects - A MULTICENTER RANDOMIZED PROSPECTIVE CLINICAL STUDY

Scientific rationale for study:

There is a paucity of data for the effectiveness of reconstructive procedures in the treatment of peri-implantitis. Recently, titanium brushes have been introduced for implant surface debridement and porous titanium granules (PTG) as an osteoconductive bone substitute.

Study design The study was designed as a prospective multicentre, multi-national, randomized, parallel group-controlled clinical trial of 6 months duration.

All participating investigators attended training and calibration meetings to discuss and optimize patient accrual and retention as well as data management. Preliminary clinical cases were discussed to standardize case selection, the measurement techniques and surgical procedures. On-site rules, for the compilation of the data collection sheets for appropriate oversight were frequently reassured by a study monitor to ensure the validity of the data.

Open flap debridement and surface decontamination with titanium brush (n = 30/Control), or additional insertion of PTG (n=33/Test) was performed for reconstruction of 3- or 4-wall intra-osseous peri-implant defects with at least 3 mm defect depth and circumferential (≥270°) morphology. Patients were given amoxicillin and metronidazole for 8 days. Radiographic and clinical assessments were performed at baseline and 6 months.