Nastaran Meschi1,2, Anke Vanhoenacker3, Olaf Strijbos4, Bernardo Camargo Dos Santos5, Eléonore Rubbers4, Valerie Peeters4, Frederik Curvers4, Maarten Van Mierlo4, Arne Geukens4, Steffen Fieuws6, Eric Verbeken7, Paul Lambrechts4,5. 1. Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium. nastaran.meschi@kuleuven.be. 2. Department of Oral Health Sciences, BIOMAT - Biomaterials Research Group, Dentistry, KU Leuven (University of Leuven), Kapucijnenvoer 7 Blok a, Box 7001, 3000, Leuven, Belgium. nastaran.meschi@kuleuven.be. 3. Stomatology and Maxillofacial Surgery, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium. 4. Department of Oral Health Sciences, UZ Leuven (University Hospitals Leuven), Dentistry, KU Leuven (University of Leuven), Leuven, Belgium. 5. Department of Oral Health Sciences, BIOMAT - Biomaterials Research Group, Dentistry, KU Leuven (University of Leuven), Kapucijnenvoer 7 Blok a, Box 7001, 3000, Leuven, Belgium. 6. Biostatistics and Statistical Bioinformatics Centre, KU Leuven (University of Leuven), Leuven, Belgium. 7. Translational Cell & Tissue Research, KU Leuven (University of Leuven), Leuven, Belgium.
Abstract
OBJECTIVES: The aim of this study was to assess in a multi-modular manner the bone healing 1 year post root-end surgery (RES) with leukocyte- and platelet-rich fibrin (LPRF) and Bio-Gide® (BG; Geistlich Pharma North America, Inc., Princeton, USA) as an occlusive membrane. MATERIALS AND METHODS: A randomized controlled clinical trial (RCT) of RES +/- LPRF and +/- BG was performed. The follow-up until 1 year post RES was performed by means of ultrasound imaging (UI), periapical radiographs (PR), and cone-beam computed tomography (CBCT). RESULTS: From the 50 included patients, 6 dropped-out during follow-up. For the 44 assessed patients (34 with UI and 42 with PR and CBCT), there was no evidence (p > 0.05) for an effect of LRPF, neither on UI measurements nor on CBCT assessments. On the contrary, there was an indication for a better outcome with BG. UI presented significant shorter healing time for the bony crypt surface (p = 0.014) and cortical opening (p = 0.006) for the groups with BG. The qualitative CBCT assessment for the combined scores of the apical area and cortical plane was significantly higher for BG (p = 0.01 and 0.02). The quantitative CBCT measurement for bone healing after 1 year was lower with BG (p = 0.019), as well as the percentage of non-zero values (p = 0.026), irrespective of the preoperative lesion size and type. Furthermore, UI seemed to be safer for frequent follow-up during the early postoperative stage (0-3 months), whereas CBCT gave more accurate results 1 year post RES. Amongst the assessors, the qualitative PR analysis was inconsistent for a favorable outcome 1 year post RES with LPRF (p = 0.11 and p = 0.023), but consistent for BG (p = 0.024 and p = 0.023). CONCLUSIONS: There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF. However, RES with BG gave evidence for a better outcome than RES without BG. CLINICAL RELEVANCE: The addition of an occlusive membrane rather than an autologous platelet concentrate improved bone regeneration 1 year post RES significantly, irrespective of the assessment device applied. The accuracy of PR assessment is questionable.
RCT Entities:
OBJECTIVES: The aim of this study was to assess in a multi-modular manner the bone healing 1 year post root-end surgery (RES) with leukocyte- and platelet-rich fibrin (LPRF) and Bio-Gide® (BG; Geistlich Pharma North America, Inc., Princeton, USA) as an occlusive membrane. MATERIALS AND METHODS: A randomized controlled clinical trial (RCT) of RES +/- LPRF and +/- BG was performed. The follow-up until 1 year post RES was performed by means of ultrasound imaging (UI), periapical radiographs (PR), and cone-beam computed tomography (CBCT). RESULTS: From the 50 included patients, 6 dropped-out during follow-up. For the 44 assessed patients (34 with UI and 42 with PR and CBCT), there was no evidence (p > 0.05) for an effect of LRPF, neither on UI measurements nor on CBCT assessments. On the contrary, there was an indication for a better outcome with BG. UI presented significant shorter healing time for the bony crypt surface (p = 0.014) and cortical opening (p = 0.006) for the groups with BG. The qualitative CBCT assessment for the combined scores of the apical area and cortical plane was significantly higher for BG (p = 0.01 and 0.02). The quantitative CBCT measurement for bone healing after 1 year was lower with BG (p = 0.019), as well as the percentage of non-zero values (p = 0.026), irrespective of the preoperative lesion size and type. Furthermore, UI seemed to be safer for frequent follow-up during the early postoperative stage (0-3 months), whereas CBCT gave more accurate results 1 year post RES. Amongst the assessors, the qualitative PR analysis was inconsistent for a favorable outcome 1 year post RES with LPRF (p = 0.11 and p = 0.023), but consistent for BG (p = 0.024 and p = 0.023). CONCLUSIONS: There was no evidence for improvement of bone healing when RES was applied with LPRF in comparison with RES without LPRF. However, RES with BG gave evidence for a better outcome than RES without BG. CLINICAL RELEVANCE: The addition of an occlusive membrane rather than an autologous platelet concentrate improved bone regeneration 1 year post RES significantly, irrespective of the assessment device applied. The accuracy of PR assessment is questionable.