Alessandro Cucchi1, Elisabetta Vignudelli2, Antonino Fiorino3, Gerardo Pellegrino2, Giuseppe Corinaldesi4. 1. Private Practice, Bologna, Italy. 2. Unit of Oral and Maxillofacial Surgery, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum-University of Bologna, Bologna, Italy. 3. Unit of Dentistry and Maxillofacial Surgery, Catholic University of Sacred Heart, University Polyclinic Foundation A. Gemelli (IRCCS), Rome, Italy. 4. Unit of First Consultation, Risk Patients and Oral Pathology, Department of Biomedical and Neuromotor Science (DIBINEM), Alma Mater Studiorum - University of Bologna, Bologna, Italy.
Abstract
OBJECTIVES: The aim of this study was to evaluate hard and soft tissues around implants placed in posterior mandible 1 year after vertical ridge augmentation (VRA). MATERIALS AND METHODS:40 patients with vertical defects were enrolled and treated according to the study protocol. Patients were randomly divided into two study groups: reinforced PTFE membranes (group A) and titanium meshes plus collagen membranes (group B). All patients received simultaneous implants which were evaluated after prosthetic restoration at baseline and after 1 year, using the following parameters: peri-implant bone levels (PBLs), interproximal bone peaks (IBPs), pocket probing depth (PPD), bleeding on probing (BoP), plaque index (mPI), gingival index (mGI), keratinized tissue thickness/width (tKT and wKT), and fornix depth (FD). Statistical analysis was performed to investigate any statistically significant differences and/or correlations (p = .05). RESULTS:30 patients were completely followed up according to the study protocol. After 1 year, implants showed a change in PBL from 0.12 to 0.76 mm, with marginal bone loss of 0.67 and 0.61 mm for group A and group B, respectively, without significant differences (p > .9337). The estimated difference between treatments for the change from baseline in PBL was -0.05 (95% CI -0.27 to 0.16). Statistical analysis revealed strong correlations between PBL and IBP (p < .0001). However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (p > .05). CONCLUSION: The results indicate that GBR treatment with titanium meshes plus collagen membranes (Group B) compared to reinforced PTFE membranes does not appear to be inferior or superior in terms of PBL change. In both groups, hard and soft tissues were stable after 1 year of follow-up, with a peri-implant bone loss less than 1.0 mm in the first year (study registered at ClinicalTrials.gov NCT04332679).
RCT Entities:
OBJECTIVES: The aim of this study was to evaluate hard and soft tissues around implants placed in posterior mandible 1 year after vertical ridge augmentation (VRA). MATERIALS AND METHODS: 40 patients with vertical defects were enrolled and treated according to the study protocol. Patients were randomly divided into two study groups: reinforced PTFE membranes (group A) and titanium meshes plus collagen membranes (group B). All patients received simultaneous implants which were evaluated after prosthetic restoration at baseline and after 1 year, using the following parameters: peri-implant bone levels (PBLs), interproximal bone peaks (IBPs), pocket probing depth (PPD), bleeding on probing (BoP), plaque index (mPI), gingival index (mGI), keratinized tissue thickness/width (tKT and wKT), and fornix depth (FD). Statistical analysis was performed to investigate any statistically significant differences and/or correlations (p = .05). RESULTS: 30 patients were completely followed up according to the study protocol. After 1 year, implants showed a change in PBL from 0.12 to 0.76 mm, with marginal bone loss of 0.67 and 0.61 mm for group A and group B, respectively, without significant differences (p > .9337). The estimated difference between treatments for the change from baseline in PBL was -0.05 (95% CI -0.27 to 0.16). Statistical analysis revealed strong correlations between PBL and IBP (p < .0001). However, no significant differences were observed for PPD, mPI, mGI, tKT, wKT, and FD (p > .05). CONCLUSION: The results indicate that GBR treatment with titanium meshes plus collagen membranes (Group B) compared to reinforced PTFE membranes does not appear to be inferior or superior in terms of PBL change. In both groups, hard and soft tissues were stable after 1 year of follow-up, with a peri-implant bone loss less than 1.0 mm in the first year (study registered at ClinicalTrials.gov NCT04332679).