A 3-year prospective randomized clinical trial of alveolar bone crest response and clinical parameters through 1, 2, and 3 years of clinical function of implants placed 4 months after alveolar ridge preservation using two different allogeneic bone-grafting materials

Abstract

Purpose The aim of this study was to longitudinally evaluate changes in alveolar bone crest (ABC) levels and differences in resorption rates (RR) between the tested grafting materials following alveolar ridge preservation (ARP) after tooth extraction after 1, 2, and 3 years (T1–T8) of clinical function. Methods Patients were randomly assigned to two different bone allografts (group 1 maxgraft®, group 2 Puros®) for ARP. Non-restorable teeth were minimal traumatically extracted. Sockets were augmented with the tested materials and covered with a pericardium membrane. After 4 months of healing, 36 implants were placed and sites were clinically and radiographically monitored in the mesial (ABC-M), the distal (ABC-D, T1–T8), the bucco-lingual (ABC-BL), buccal (ABC-B) and oral (ABC-O) aspect (T1–T4). Results Changes in (ABC-M), (ABC-D), (ABC-BL), (ABC-B), and (ABC-O) levels showed statistically highly significant differences between T1 and T2 for both bone allografts (p < 0.001). Changes at the ABC-M and ABC-BL levels between T2 and T3 of group 1 showed a statistically significant difference (p < 0.001). Both groups achieved and maintained increased ABC levels without statistically significant differences throughout the monitoring periods of 1–3 years (T6–T8) of clinical function. No failures or adverse events were observed. Conclusions To the best of our knowledge, this study is within its limitations the first study to directly compare ABC-changes and differences in RR of two different allogeneic grafting materials for a period of 3 years after ARP. It was demonstrated to be, despite significant differences in RR, a successful method of preserving increased ABC levels through 1, 2, and 3 years of clinical function. Trial registration DRKS00013010, registered 07/30/2018, http://apps.who.int/trialsearch

Characterization of immunologically detectable T-cell sensitization, Immunohistochemical detection of pro-inflammatory cytokines, and clinical parameters of patients after allogeneic intraoral bone grafting procedures: a prospective randomized controlled clinical trial in humans

“…Group C of both materials demonstrated a comparable delayed wound healing and group C of test group 1 (Maxgraft®) demonstrated a higher amount of bone resorption which made a second bone grafting procedure at time of implant placement necessary. This difference in bone resorption was also observed in another recently published prospective randomized clinical trial [ 63 ]. Again, there was no statistically significant difference detectable between both materials, which was most likely due to the low sample size, but a strong clinical association was observed.…”

Advancements in alveolar bone grafting and ridge preservation: a narrative review on materials, techniques, and clinical outcomes

“… Bone resorption rates: a 3-year prospective randomized clinical trial aimed to analyze the changes in alveolar bone crest levels and differences in resorption rates between various grafting materials used in ARP post-tooth extraction. The study spanned evaluations over 1, 2, and 3 years of clinical function [ 44 ]. Another study observed that alveolar ridge resorption often occurs within the first 6 months post-tooth extraction, with the resorption rate decreasing gradually over the years.…”

Clinical and Biological Validation of an Allogeneous Cancellous Bone Block for Alveolar Maxillary Ridge Reconstruction: A Case Series

“…Implant treatments in affected patients may require preceding or simultaneous boneaugmentative procedures [2]. Among the different treatment options, block grafts have recently attracted considerable interest due to their ability to predictably increase the horizontal alveolar dimension [3][4][5][6]. Recent systematic reviews and individual studies have reported the superior capacity to maintain volume and reduced risk of graft dislocation of block grafting compared to guided bone regeneration (GBR) using particulate material [2,7,8].…”

“…The material undergoes physical and chemical purification steps, including solvent extraction and oxidative chemical treatment, followed by freeze-drying and sterilization to remove cells and antigens, inactivate potential viruses and bacteria, and render the material sterile for clinical use [21,22]. Solakoglu et al recently reported significant differences between two similar types of granular allografts, comprising Maxgraft granules, in augmenting and maintaining alveolar dimensions as part of a two-staged single implant restorative procedure while failing to show differences as part of an earlier human immunohistochemical and histometric study [6,23]. This controversy emphasizes the limited comparability between individual allografts and suggests a requirement for the material-and type-specific characterization and clinical performance validation of individual allografts.…”