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A multicenter randomized controlled clinical trial using a new resorbable non-cross-linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure.

ABSTRACT: OBJECTIVE:To compare clinical performance of a new resorbable non-cross-linked collagen membrane, creos xenoprotect (CXP), with a reference membrane (BG) for guided bone regeneration at dehisced implant sites. MATERIALS AND METHODS:This randomized controlled clinical trial enrolled patients with expected dehiscence defects following implant placement to restore single teeth in the maxillary and mandibular esthetic zone and premolar area. Implants were placed using a two-stage surgical protocol with delayed loading. Bone augmentation material placed at the implant surface was immobilized with CXP or BG membrane. Soft tissue health was followed during the healing period, and the defect size was measured at reentry and 6 months after implant placement. RESULTS:Of the 49 included patients, 24 were treated with CXP and 25 with BG. Patient characteristics did not differ between the two arms. In the CXP arm, the defect height at implant insertion was (mean ± SD) 5.1 ± 2.1 mm (n = 24) and reduced at reentry by 81% to 1.0 ± 1.3 mm (n = 23). In the BG arm, the defect height at implant insertion was 4.9 ± 1.9 mm (n = 25) and reduced at reentry by 62% to 1.7 ± 2.1 mm (n = 24). Assuming a margin of non-inferiority of 1 mm, CXP was non-inferior to BG. Membrane exposure rate was highest at week 3 in both arms, reaching 16.7% for BG and 8.7% for CXP. CONCLUSIONS:The new resorbable non-cross-linked collagen membrane facilitates bone gain to support implant placement in expected dehiscence defects. The observed trend toward higher mean bone gain and lower exposure rate with CXP compared to BG should be further investigated.

SUBMITTER: Wessing B

PROVIDER: S-EPMC5697637 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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A multicenter randomized controlled clinical trial using a new resorbable non-cross-linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure.

Wessing Bastian B Urban Istvan I Montero Eduardo E Zechner Werner W Hof Markus M Alández Chamorro Javier J Alández Martin Nuria N Polizzi Giovanni G Meloni Silvio S Sanz Mariano M

Clinical oral implants research 20161218 11

<h4>Objective</h4>To compare clinical performance of a new resorbable non-cross-linked collagen membrane, creos xenoprotect (CXP), with a reference membrane (BG) for guided bone regeneration at dehisced implant sites.<h4>Materials and methods</h4>This randomized controlled clinical trial enrolled patients with expected dehiscence defects following implant placement to restore single teeth in the maxillary and mandibular esthetic zone and premolar area. Implants were placed using a two-stage surg ...[more]

PMID: 27990692

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Project description:BACKGROUND:The use of guided bone regeneration (GBR) for vertical and horizontal bone gain is a predictable approach to correct the bone defects before implant installation; however, the use of different protocols is associated with different clinical results. It is suggested that platelet-rich fibrin (PRF) could improve the outcomes of regenerative procedures. Thus, this study aimed to describe the bone gain associated with GBR procedures combining membranes, bone grafts, and PRF for vertical and horizontal bone augmentation. MATERIALS AND METHODS:Eighteen patients who needed vertical or horizontal bone regeneration before installing dental implants were included in the study. The horizontal bone defects were treated with a GBR protocol that includes the use of a mixture of particulate autogenous and xenogenous grafts in the proportion of 1:1, injectable form of PRF (i-PRF) to agglutinate the graft, an absorbable collagen membrane covering the regenerated region, and leukocyte PRF (L-PRF) membrane covering the GBR membrane. The vertical bone defects were treated with the same grafted mixture protected by a titanium-reinforced non-resorbable high-density polytetrafluoroethylene (d-PTFE-Ti) membrane and covered by L-PRF. The bone gain was measured using a cone-beam computed tomography at baseline and after a period of 7.5 (± 1.0) months. RESULTS:All patients underwent surgery to install implants after this regenerative protocol. The GBR produces an increase in bone thickness (p < 0.001) and height (p < 0.005) after treatment, with a bone gain of 5.9 ± 2.4 for horizontal defects and 5.6 ± 2.6 for vertical defects. In horizontal defects, the gain was higher in the maxilla than in mandible (p = 0.014) and in anterior than the posterior region (p = 0.033). No differences related to GBR location were observed in vertical defects (p > 0.05). CONCLUSION:GBR associated with a mixture of particulate autogenous and xenogenous grafts and i-PRF is effective for vertical and horizontal bone augmentation in maxillary and mandibular regions, permitting sufficient bone gain to future implant placement. TRIAL REGISTRATION:REBEC, RBR-3CSG3J . Date of registration-19 July 2019, retrospectively registered. http://www.ensaiosclinicos.gov.br/rg/RBR-3csg3j/.

Dataset Information

A multicenter randomized controlled clinical trial using a new resorbable non-cross-linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure.

Publications

A multicenter randomized controlled clinical trial using a new resorbable non-cross-linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure.

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