Ronald Ernst Jung1, Ilja Mihatovic2, Luca Cordaro3, Péter Windisch4, Anton Friedmann5, Juan Blanco Carrion6, Ignacio Sanz Sanchez7, Mats Hallman8, Marc Quirynen9, Christoph H F Hammerle1. 1. Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland. 2. Department of Oral Surgery, Heinrich Heine University, Düsseldorf, Germany. 3. Department of Periodontics and Prosthodontics, Policlinico Umberto I, Eastman Dental Hospital, Rome, Italy. 4. Department of Periodontology, Semmelweis University, Budapest, Hungary. 5. Department of Periodontology, School of Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany. 6. Periodontology Unit, School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain. 7. ETEP (Etiology and Therapy of Periodontal Diseases) Research Group, University Complutense, Madrid, Spain. 8. Department of Oral and Maxillofacial Surgery, Public Health Service, Gävle, Sweden. 9. Section of Periodontology, Department of Oral Health Sciences, KU Leuven, Leuven, Belgium.
Abstract
OBJECTIVES: The aim of the present randomized, controlled clinical multicenter trial was to compare a polyethylene glycol (PEG) and a native collagen membrane (BG) for simultaneous guided bone regeneration at bony dehiscence-type defects around bone level titanium implants. MATERIAL AND METHODS: The study enrolled 117 patients requiring implant treatment in the posterior maxilla or mandible with expected buccal bony dehiscence-type defects at the placed titanium implants. According to a parallel groups design, defects were filled with a synthetic bone filler and randomly assigned to either PEG or BG membrane. As primary parameter, the relative vertical bone fill was assessed at baseline and at re-entry after 6 months of healing. As secondary parameters, the marginal bone level (MBL) was assessed radiographically and soft tissue conditions were recorded up to 18 months postloading. RESULTS: Both groups showed comparable vertical bone fill revealing a relative change in defect height of 59.7% (PEG) and 64.4% (BG). The absolute mean reduction in defect size was 2.5 mm in the PEG group and 3.2 mm in the BG group. Although both groups revealed a statistically significant mean defect reduction (p < .001), a comparison between the two groups did not show statistical significances. The non-inferiority test with inferiority limit of -5% could not be rejected, based on the 90% confidence interval of the differences of the two means with lower limit -15.4%. After 18 months, an MBL increase of 0.45 ± 0.43 mm in the PEG group and 0.41 ± 0.81 mm in the BG group was detected (p < .001). Soft tissue complications were observed in both groups without showing statistical significance. CONCLUSIONS: Both membranes supported bone regeneration at dehiscence-type defects and obtained vertical bone fill with a relative change in defect height of 59.7% (PEG) and 64.4% (BG); however, the non-inferiority of PEG could not be shown.
OBJECTIVES: The aim of the present randomized, controlled clinical multicenter trial was to compare a polyethylene glycol (PEG) and a native collagen membrane (BG) for simultaneous guided bone regeneration at bony dehiscence-type defects around bone level titanium implants. MATERIAL AND METHODS: The study enrolled 117 patients requiring implant treatment in the posterior maxilla or mandible with expected buccal bony dehiscence-type defects at the placed titanium implants. According to a parallel groups design, defects were filled with a synthetic bone filler and randomly assigned to either PEG or BG membrane. As primary parameter, the relative vertical bone fill was assessed at baseline and at re-entry after 6 months of healing. As secondary parameters, the marginal bone level (MBL) was assessed radiographically and soft tissue conditions were recorded up to 18 months postloading. RESULTS: Both groups showed comparable vertical bone fill revealing a relative change in defect height of 59.7% (PEG) and 64.4% (BG). The absolute mean reduction in defect size was 2.5 mm in the PEG group and 3.2 mm in the BG group. Although both groups revealed a statistically significant mean defect reduction (p < .001), a comparison between the two groups did not show statistical significances. The non-inferiority test with inferiority limit of -5% could not be rejected, based on the 90% confidence interval of the differences of the two means with lower limit -15.4%. After 18 months, an MBL increase of 0.45 ± 0.43 mm in the PEG group and 0.41 ± 0.81 mm in the BG group was detected (p < .001). Soft tissue complications were observed in both groups without showing statistical significance. CONCLUSIONS: Both membranes supported bone regeneration at dehiscence-type defects and obtained vertical bone fill with a relative change in defect height of 59.7% (PEG) and 64.4% (BG); however, the non-inferiority of PEG could not be shown.
Authors: Anton Friedmann; Stefan Fickl; Kai R Fischer; Milad Dalloul; Werner Goetz; Frederic Kauffmann Journal: Materials (Basel) Date: 2021-12-29 Impact factor: 3.623