Demineralized bone matrix for repair and regeneration of maxillofacial defects: A narrative review.

OBJECTIVES: Demineralized bone matrix (DBM) is a well-established bone graft material widely accepted by dentists and the public for its favorable osteoconductivity and osteoinductive potential. This article aimed to provide a narrative review of the current therapeutic applications and limitations of DBM in maxillofacial bone defects. STUDY SELECTION, DATA, AND SOURCES: Randomized controlled trials, prospective or retrospective clinical studies, case series and reports, and systematic reviews. MEDLINE, PubMed, and Google Scholar were searched using keywords. CONCLUSIONS: Some evidence supported the therapeutic application of DBM in periodontal intrabony defects, maxillary sinus lifts, ridge preservation, ridge augmentation, alveolar cleft repair, orthognathic surgery, and other regional maxillofacial bone defects. However, the limitations of DBM should be considered when using it, including potential low immunogenicity, instability of osteoinductive potential, handling of the graft material, and patient acceptance. CLINICAL SIGNIFICANCE: With the increasing demand for the treatment of maxillofacial bone defects, DBM is likely to play a greater role as a promising bone graft material. Safe and effective combination treatment strategies and how to maintain a stable osteoinductive potential will be the future challenges of DBM research.

Comparison of different bone substitutes in the repair of rat calvaria critical size defects: questioning the need for alveolar ridge presentation.

OBJECTIVE: This study aimed to evaluate the effectiveness of biomaterials in bone healing of critical bone defects created by piezoelectric surgery in rat calvaria. METHOD AND MATERIALS: Histomorphologic analysis was performed to assess bone regeneration and tissue response. Fifty animals were randomized into five groups with one of the following treatments: Control group (n = 10), spontaneous blood clot formation with no bone fill; BO group (Bio-Oss, Geistlich Pharma; n = 10), defects were filled with bovine medullary bone substitute; BF group (Bonefill, Bionnovation; n = 10), defects were filled with bovine cortical bone substitute; hydroxyapatite group (n = 10), defects were filled with hydroxyapatite; calcium sulfate group (n = 10), defects were filled with calcium sulfate. Five animals from each group were euthanized at 30 and 45 days. The histomorphometry calculated the percentage of the new bone formation in the bone defect. RESULTS: All data obtained were evaluated statistically considering P < .05 as statistically significant. The results demonstrated the potential of all biomaterials for enhancing bone regeneration. The findings showed no statistical differences between all the biomaterials at 30 and 45 days including the control group without bone grafting. CONCLUSION: In conclusion, the tested biomaterials presented an estimated capacity of osteoconduction, statistically nonsignificant between them. In addition, the selection of biomaterial should consider the specific clinical aspect, resorption rates, size of the particle, and desired bone healing responses. It is important to emphasize that in some cases, using no bone filler might provide comparable results with reduced cost and possible complications questioning the very frequent use of ridge presentation procedures.

Comparative Osteogenesis of Three Clinical Bone Graft Materials: An In Vivo Study.

PURPOSE: To investigate bone regeneration among three different bone graft materials in a rat calvarum model. MATERIALS AND METHODS: A total of 24 rats had two 5-mm defects placed per calvarial. Rats were divided into four groups: bovine xenograft (XG), demineralized bone matrix (DBM), mineralized bone graft (MBG), and collagen membrane control (CC). Within each group, samples were collected at two time points: 4 weeks (T4) and 8 weeks (T8). Bone regeneration was assessed by microcomputed tomography (micro-CT) imaging and was analyzed using MATLAB software. Additionally, the fixed samples were subsequently demineralized for immunohistochemistry and histomorphometry. Slides were mounted and stained with hematoxylin and eosin (H&E) stain as well as bone morphogenetic protein 2 (BMP-2) and runt-related transcription factor 2 (RUNX2) markers. The numbers of positive cells/area were calculated for each group and analyzed. RESULTS: At 4 weeks, DBM showed low mineral density (7.7%) compared to the control (25.2%), but increased dramatically at 8 weeks (DBM, T8 = 27.6%; CC, T8 = 27.2%). Xenograft material showed an increase in mineral desnity between T4 and T8 (XG, T4 = 25.0%; XG, T8 = 32.3%). MBG remained consistent over the 8-week trial period (MBG, T4 = 30.4%; MBG, T8 = 30.4%). BMP-2 expression was present in cells adherent to all graft materials. RUNX2 expression was also observed in cells adherent to all graft materials, indicating that during the 4- to 8-week healing period, all materials supported osteogenesis. CONCLUSIONS: Compared to other materials, the DBM had high osteoinductive properties during the 4- to 8-week time period based on increased mineral content. All materials were associated with immunohistologic evidence of osteogenesis in the rat calvarial defect model.

Comparison of demineralized bone matrix with different cycling crushing times in posterolateral fusion model of athymic rats.

Decalcified bone matrix (DBM) is a widely used alternative material for bone transplantation. In the DBM production process, an effective particle size and the highest utilization rate of raw materials can be achieved only through multiple high-speed circulating comminution. The rat posterolateral lumbar fusion model (PLF) is the most mature small animal model for the initial evaluation of the efficacy of graft materials for bone regeneration and spinal fusion. To evaluate the differences in the in vivo osteogenic effects of DBM pulverization through 1, 5, 9, and 14 high-speed cycles, sixty athymic rats were divided into six groups: single cycling crushing (CC1), 5 cycles of crushing (CC5), 9 cycles of crushing (CC9), 13 cycles of crushing (CC13), autogenous bone graft (ABG) and negative control (NC). Posterolateral lumbar fusion was performed. Six weeks after surgery, the bilateral lumbar fusion of athymic rats was evaluated through manual palpation, X-ray, micro-CT and histological sections. Rank data were tested by the rank-sum test, and nonparametric data were tested by the Kruskal‒Wallis H test. The manual palpation and X-ray results showed that the fusion rate did not significantly differ between the CC1, CC5, CC9, CC13 and ABG groups. However, cavities appeared in CC9 and CC13 on the micro-CT image. The bone mass (BV/TV) of CC1, CC5, CC9 and CC13 was better than that of the ABG group, while almost no osteogenesis was observed in the NC group. Histologically, there was no obvious difference between the four groups except that the CC9 group and CC13 group had more fibrous tissues in the new bone. In conclusion, DMB with different cycling crushing times has no obvious difference in fusion rate of PLF, but it is slightly better than the ABG group.

12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery.

BACKGROUND: To investigate the clinical safety and efficacy of ViBone® Viable Bone Matrix (VBM), a next generation cellular bone matrix allograft that comprises all three essential bone-forming components: osteogenic, osteoinductive, and osteoconductive factors, and is optimized to enhance cell viability and bone formation. METHODS: This was a multi-center, prospective, post-market study evaluating the safety and efficacy of ViBone VBM in patients undergoing 1-3 level anterior cervical discectomy and fusion or lumbar interbody fusion surgery. Patients were evaluated at baseline, 6-month, and 12-month follow-up clinically and radiographically. Clinical assessment included Visual Analog Scale for pain (VAS-pain), the Neck Disability Index (NDI) for patients with cervical pathologies, and the Oswestry Disability Index (ODI) for patients with lumbar pathologies. Fusion success defined by an independent radiologist was determined radiographically by plain films. RESULTS: Clinical outcomes evaluated with VAS-pain, NDI, and ODI scales were improved significantly at 6 and 12 months compared to baseline. All patients reached clinically significant improvements at 12 months. There were no adverse events or infections attributed to ViBone VBM. At 12 months, the fusion rate per patient was 88.1% in cervical and 97.6% in lumbar patients, while per-level fusion was 98.5% for cervical and 100% for lumbar segments. CONCLUSIONS: Patients undergoing cervical and lumbar spinal fusion implanted with ViBone VBM demonstrated favorable outcomes at 6 months and 12 months as measured by subjective clinical measures and radiographic fusion rates. Trial registration This study was registered as NCT03425682 on 1/29/2018.

Use of biphasic calcium phosphate versus demineralized bone matrix: retrospective clinical and CT analysis of posterolateral fusion results.

PURPOSE: Bone graft extenders have been developed to prevent donor site morbidity associated with iliac crest bone graft, but few studies compared the efficacy of various substitutes. Our purpose was to determine fusion rate and clinical outcome in patients undergoing lumbar arthrodesis using demineralized bone matrix (DBM) and biphasic calcium phosphate (BCP). METHODS: Patients with degenerative spondylolisthesis undergoing one-level or two-level arthrodesis of lumbar spine were retrospectively reviewed. Two treatment groups placed either BCP or DBM, in addition to local autograft in lumbar posterolateral space. Three-dimensional CT exam and dynamic flexion-extension radiographs at postoperative 2-year were assessed for posterolateral fusion status and pain scale and Oswestry Disability Index (ODI) for clinical outcome. RESULTS: Of the 148 patients reviewed (including 23 in one- and 58 patients in two-level in BCP group, and 47 in one- and 20 patients in two-level in DBM group), no significant differences were found in terms of age, sex, BMI, smoking, diabetes, steroids, number of level fused, non-union rate or revision surgery between BCP and DBM groups. Significantly improved pain scale of back and leg and ODI were found in both groups postoperatively without group difference. We found a comparable fusion rate in one-level surgery (100% versus 93.6%) and a superior fusion rate of BCP group in two-level surgery (98.3% versus 80.0%, p = 0.01). CONCLUSION: Being a bone graft extender without osteoinductive property, with local autograft, BCP is comparable to DBM for one- and superior for two-level fusion. No significant difference was found in clinical outcomes.

Histopathological and radiographical evaluation of caprine demineralized bone matrix in a critical ulnar defect in a rabbit model.

BACKGROUND: Caprine species satisfy the conditions of an ideal donor animal when compared to bovine species that has been extensively studied and commercialized for bone xenograft. Histopathological and radiological evaluations of caprine demineralized bone matrix (CDBM) were therefore carried out for fracture healing properties for its possible use in bone grafting procedures. MATERIALS AND METHODS: Twenty-four rabbits were used for this study and were divided randomly into three groups of eight (n = 8) rabbits each. Critical bone defect was created on the ulnar diaphysis under xylazine-ketamine anaesthesia for autogenous bone graft (ABG) group, CDBM group and the last group was left unfilled as negative control (NC). Immediate post-grafting radiograph was taken and repeated on days 14, 28, 42 and 56 to monitor the evidence of radiographic healing. The animals were euthanized on day 56 and defect sites were harvested for histopathology. RESULTS: There was a progressive evidence of radiographic healing and bone formation in all the groups with significance difference (P = 0.0064). When compared with ABG, NC differ significantly (P < 0.0001) whereas the CDBM did not differ significantly (P = 0.6765). The histopathology sections of ABG and CDBM showed normal bone tissue while the NC section was predominated by fibrous connective tissue. There was therefore an overall significant difference (P = 0.0001) in which CDBM did not differ from ABG (P = 0.2946) while NC did (P = 0.0005). CONCLUSION: The ABG and CDBM groups showed a similar healing effect in the critical bone defect. Therefore, CDBM could be used as an effective alternative to ABG in orthopaedics to circumvent the limitations and complications associated with it. LEVEL OF EVIDENCE: Not applicable.

Comparative Assessment of Autogenous Cancellous Bone Graft and Bovine-Derived Demineralized Bone Matrix for Secondary Alveolar Bone Grafting in Patients With Unilateral Cleft Lip and Palate.

OBJECTIVE: Comparison between bovine-derived demineralized bone matrix (DMBM) and iliac crest graft over long term for secondary alveolar bone grafting (SABG) in patients with unilateral cleft lip and palate (UCLP) in terms of radiological and clinical outcomes. DESIGN: Prospective, randomized, parallel groups, double-blind, controlled trial. SETTING: Unit of Oral and Maxillofacial Surgery, Oral Health Science Centre, Postgraduate Institute of Medical Education & Research, Chandigarh. PARTICIPANTS: Twenty patients with UCLP. INTERVENTIONS: Patients were allocated into group I (Iliac crest bone graft) and group II (DMBM) for SABG. Outcomes were assessed at 2 weeks, 6 months, and then after mean follow-up period of 63 months. OUTCOMES MEASURES: Volumetric analysis of the grafted bone in the alveolar cleft site was done through cone beam computed tomography using Cavalieri principle and modified assessment tool. Clinical assessment was performed in terms of pain, swelling, duration of hospital stay, cost of surgery, alar base symmetry, and donor site morbidity associated with iliac crest harvesting. RESULTS: Volumetric analysis through Cavalieri principle revealed comparable bone uptake at follow-up of 6 months between group I (70%) and group II (69%). Modified assessment tool showed no significant difference between horizontal and vertical bone scores over short- and long-term follow-up. In group II, there was higher cost of surgery, but no donor site morbidity unlike group I. CONCLUSIONS: Demineralized bone matrix proved analogous to iliac crest bone graft as per volumetric analysis over shorter period. However, although statistically insignificant, net bone volume achieved was lower than the iliac crest graft at longer follow-up.

Bone Graft Options in Spinal Fusion: A Review of Current Options and the Use of Mesenchymal Cellular Bone Matrices.

BACKGROUND: Spinal fusion is the mainstay treatment for various spinal conditions ranging from lumbar and cervical stenosis to degenerative spondylolisthesis as well as extensive deformity corrections. A new emerging category of allograft is cellular bone matrices (CBMs), which take allogeneic mesenchymal stem cells and incorporate them into an osteoconductive and osteoinductive matrix. This study reviewed the current spinal fusion options and new emerging treatment options. METHODS: Articles were searched using PubMed. The search included English publications since January 1, 2014, using the search terms "cellular bone matrix," "mesenchymal stem cells spinal fusion," "spinal arthrodesis AND mesenchymal stem cells," and "spine fusion AND cellular bone matrix." RESULTS: Spinal fusion is accomplished through the use of allografts, autografts, and bone graft substitutes in combination or alone. An emerging category of allograft is CBMs, in which an osteoconductive and osteoinductive matrix is filled with mesenchymal stem cells. Studies demonstrate that CBMs have achieved equivalent or better fusion rates compared with traditional options for anterior cervical discectomy and fusions and posterolateral lumbar fusions; however, the studies have been retrospective and lacking control groups and therefore not ideal. CONCLUSIONS: Many treatment options have been successfully used in spinal fusion. Newer allografts such as CBMs have shown promising results in both animal and clinical studies. Further research is needed to determine the therapeutic dose of mesenchymal stem cells delivered within CBMs.

Treatment of En Coup de Sabre Deformity with Fat Grafting and Demineralized Bone Matrix: A Case Series.

En coup de sabre deformity (ECDS) is a form of localized scleroderma in the frontoparietal region caused by progressive subcutaneous tissue atrophy and bony defect. Although ECDS involves two layers, skin/subcutaneous tissue and bone, the existing literature mainly focuses only on treating the skin/subcutaneous tissue layer. In this case series, we aimed to propose a novel approach that includes the combined use of fat grafting and demineralized bone matrix (DBM). Four patients with ECDS deformity, operated between February 2016 and October 2018, were retrospectively evaluated. All the patients were treated with the novel approach. Patients were evaluated with localized scleroderma scale and computed tomography (CT) scan in the preoperative period and at the annual follow-up. We observed remarkable improvement in the localized scleroderma scale including appearance, palpation, and size scores in all patients at the annual follow-up. CT scans at the annual follow-up revealed new callus formation at the bony defect area in all patients. Reinforcing fat grafting with DBM could promote healing of the bony and skin/subcutaneous tissue defects associated with ECDS.

Fibrous Demineralized Bone Matrix (DBM) Improves Bone Marrow Mononuclear Cell (BMC)-Supported Bone Healing in Large Femoral Bone Defects in Rats.

Regeneration of large bone defects is a major objective in trauma surgery. Bone marrow mononuclear cell (BMC)-supported bone healing was shown to be efficient after immobilization on a scaffold. We hypothesized that fibrous demineralized bone matrix (DBM) in various forms with BMCs is superior to granular DBM. A total of 65 male SD rats were assigned to five treatment groups: syngenic cancellous bone (SCB), fibrous demineralized bone matrix (f-DBM), fibrous demineralized bone matrix densely packed (f-DBM 120%), DBM granules (GDBM) and DBM granules 5% calcium phosphate (GDBM5%Ca2+). BMCs from donor rats were combined with different scaffolds and placed into 5 mm femoral bone defects. After 8 weeks, bone mineral density (BMD), biomechanical stability and histology were assessed. Similar biomechanical properties of f-DBM and SCB defects were observed. Similar bone and cartilage formation was found in all groups, but a significantly bigger residual defect size was found in GDBM. High bone healing scores were found in f-DBM (25) and SCB (25). The application of DBM in fiber form combined with the application of BMCs shows promising results comparable to the gold standard, syngenic cancellous bone. Denser packing of fibers or higher amount of calcium phosphate has no positive effect.

A partially demineralized allogeneic bone graft: in vitro osteogenic potential and preclinical evaluation in two different intramembranous bone healing models.

In skeletal surgical procedures, bone regeneration in irregular and hard-to-reach areas may present clinical challenges. In order to overcome the limitations of traditional autologous bone grafts and bone substitutes, an extrudable and easy-to-handle innovative partially demineralized allogenic bone graft in the form of a paste has been developed. In this study, the regenerative potential of this paste was assessed and compared to its clinically used precursor form allogenic bone particles. Compared to the particular bone graft, the bone paste allowed better attachment of human mesenchymal stromal cells and their commitment towards the osteoblastic lineage, and it induced a pro-regenerative phenotype of human monocytes/macrophages. The bone paste also supported bone healing in vivo in a guide bone regeneration model and, more interestingly, exhibited a substantial bone-forming ability when implanted in a critical-size defect model in rat calvaria. Thus, these findings indicate that this novel partially demineralized allogeneic bone paste that combines substantial bone healing properties and rapid and ease-of-use may be a promising alternative to allogeneic bone grafts for bone regeneration in several clinical contexts of oral and maxillofacial bone grafting.

Is percutaneous injection of bone marrow concentrate, demineralized bone matrix and PRF an alternative to curettage and bone grafting for treating aneurysmal bone cyst?

To determine the efficacy and safety of a single injection with autologous bone marrow concentrate (BMC) combined with demineralized bone matrix (DBM) and platelet-rich fibrin (PRF) compared to curettage and bone grafting for treating aneurysmal bone cysts (ABC). Two hundred thirty-nine patients were treated with curettage and bone grafting (Curettage Group), and 21 with percutaneous injection of DBM associated with autologous BMC and PRF (DBM + BMC + PRF Group). All patients attended the outpatient clinic to assess ABC healing and clinical results at the first 3, 6, 9 and 18 months after surgery and then annually in the absence of symptoms. The mean follow-up was 42 months for the Curettage Group (range 6-180 months) and 28 months for the DBM + BMC + PRF Group (range, 6-85 months). Out of the 21 patients who had injection with BMC, DBM, and PRF, 17 (80%) require no additional treatment and they were considered healed. Of the 239 patients treated with curettage and bone grafting after core needle or open biopsy, 177 (74%) were considered healed after the first treatment. Injection in comparison with curettage presented the same risk for local recurrence. The overall rate of local recurrence for all patients was 25%. Univariate and multivariate analyses showed a significant difference in local recurrence rates in patients younger than 15 years, and for the cyst located in the long bones of the lower limbs than the cyst located in the long bones of the upper limbs.

Early to medium term outcomes of osteochondral lesions of the talus treated by autologous matrix induced chondrogenesis (AMIC).

BACKGROUND: The primary aim of the study is to evaluate the functional outcome following AMIC procedure in patients with osteochondral injury of the talus. The secondary aim is to evaluate if size of the lesion and patient's age influence outcome. MATERIALS AND METHODS: This is a retrospective study of 25 patients who underwent AMIC procedure of the talus treated by a single surgeon. Functional outcomes were evaluated using pre and post operative AOFAS and VAS scores. RESULTS: The mean lesion size was 1.74 cms with 88% of lesions in the study more than 1.4 cms. There was a significant improvement in AOFAS score with mean improvement of 49.40 (p < 0.05) and VAS score of 5.36 (p < 0.05). We could not find any correlation between either age or lesion size with functional outcome for AMIC procedure. CONCLUSION: AMIC procedure seems to be a reliable treatment method for larger diameter osteochondral lesions of the talus up to 2.5 cms in diameter.

Examination of the Role of Cells in Commercially Available Cellular Allografts in Spine Fusion: An in Vivo Animal Study.

BACKGROUND: Despite the extensive use of cellular bone matrices (CBMs) in spine surgery, there is little evidence to support the contribution of cells within CBMs to bone formation. The objective of this study was to determine the contribution of cells to spinal fusion by direct comparisons among viable CBMs, devitalized CBMs, and cell-free demineralized bone matrix (DBM). METHODS: Three commercially available grafts were tested: a CBM containing particulate DBM (CBM-particulate), a CBM containing DBM fibers (CBM-fiber), and a cell-free product with DBM fibers only (DBM-fiber). CBMs were used in viable states (CBM-particulatev and CBM-fiberv) and devitalized (lyophilized) states (CBM-particulated and CBM-fiberd), resulting in 5 groups. Viable cell counts and bone morphogenetic protein-2 (BMP-2) content on enzyme-linked immunosorbent assay (ELISA) within each graft material were measured. A single-level posterolateral lumbar fusion was performed on 45 athymic rats with 3 lots of each product implanted into 9 animals per group. After 6 weeks, fusion was assessed using manual palpation, micro-computed tomography (µ-CT), and histological analysis. RESULTS: The 2 groups with viable cells were comparable with respect to cell counts, and pairwise comparisons showed no significant differences in BMP-2 content across the 5 groups. Manual palpation demonstrated fusion rates of 9 of 9 in the DBM-fiber specimens, 9 of 9 in the CBM-fiberd specimens, 8 of 9 in the CBM-fiberv specimens, and 0 of 9 in both CBM-particulate groups. The µ-CT maturity grade was significantly higher in the DBM-fiber group (2.78 ± 0.55) compared with the other groups (p < 0.0001), while none of the CBM-particulate samples demonstrated intertransverse fusion in qualitative assessments. The viable and devitalized samples in each CBM group were comparable with regard to fusion rates, bone volume fraction, µ-CT maturity grade, and histological features. CONCLUSIONS: The cellular component of 2 commercially available CBMs yielded no additional benefits in terms of spinal fusion. Meanwhile, the groups with a fiber-based DBM demonstrated significantly higher fusion outcomes compared with the CBM groups with particulate DBM, indicating that the DBM component is probably the key determinant of fusion. CLINICAL RELEVANCE: Data from the current study demonstrate that cells yielded no additional benefit in spinal fusion and emphasize the need for well-designed clinical studies on cellular graft materials.

Combined therapy of adipose-derived stem cells and photobiomodulation on accelerated bone healing of a critical size defect in an osteoporotic rat model.

We investigated the impact of human demineralized bone matrix (hDBM) plus adipose-derived stem cells (hADS) plus photobiomodulation (PBM) on a critical-sized femoral defect (CSFD) in ovariectomy induced osteoporosis in rats. There were 6 groups as follows. In group 1 (control, C), only CSFDs were created. Groups 2-6 were implanted with DBM into the CSFD (DBM-CSFD). In group 2 (S), only DBM was transplanted into the CSFD. In group 3 (S + PBM), the DBM-CSFDs were treated with PBM. In group 4, the DBM-CSFDs were treated with alendronate (S + ALN). In group 5, ADSs were seeded into DBM-CSFD (S + ADS). In group 6, ADSs were seeded into DBM-CSFD and the CSFDs were treated with PBM (S + PBM + ADS). At week eight (catabolic phase of bone repair), the S + ALN, S + PBM + ADS, S + PBM, and S + ADS groups all had significantly increased bone strength than the S group (ANOVA, p = 0.000). The S + PBM, S + PBM + ADS, and S + ADS groups had significantly increased Hounsfield unit than the S group (ANOVA, p = 0.000). ALN, ADS, and PBM significantly increased healed bone strength in an experimental model of DBM-treated CSFD in the catabolic phase of bone healing in osteoporotic rats. However, ALN alone and PBM plus ADS were superior to the other protocols.

Comparison of morphological quantitative characteristics of the newly formed alveolar bone after the application of demineralized bone matrix and cortical bone allografts / Comparación de las características morfológicas cuantitativas del hueso alveolar recién formado después de la aplicación de matriz ósea desmineralizada y aloinjertos de hueso cortical

The allografts were used to obtain sufficient alveolar bone tissue for proper dental implant placement. The objective of the present study was to evaluate the morphological and quantitative characteristics (cellular and collagen densities) of the newly formed alveolar bone with the application of cortical bone (CB) and demineralized bone matrix (DBM) allografts. Six samples of alveolar bone tissue from 5 patients (50 ± 6.3 years) were obtained after 6 months of application of the allografts and immediately before the placement of the dental implants. The samples were fixed (buffered formaldehyde, pH7.2), decalcified (EDTA 10 %) and histologically processed (HE and Picro-Sirius) for histologic analysis. Morphological analysis revealed presence of osteocytes and trabeculae in neoformed bone tissue near the allografts and absence of inflammatory and allergic cells; the remnants of CB were located mainly in the periphery of the bone tissue and the remnants of DBM were more incorporated into the tissue. Osteogenitor cells were observed around the remaining material. The cell density was not modified in newly formed bone tissue with the application of both allografts as compared to mature bone tissue. The density of the type I and III collagens present in the osteoids interspersed with the remainder of the materials showed a tendency to increase in the samples treated with DBM. It was concluded that by the histological characteristics observed both grafts were biocompatible, however the bone treated with DBM presented better incorporation and a tendency of increase of the collagen content in the remnant region of the allografts.

Los aloinjertos son utilizados para obtener tejido óseo alveolar apropiado para la colocación correcta del implante dental. El objetivo de este trabajo fue evaluar las características morfológicas y cuantitativas (densidades celulares y de colágeno) del hueso alveolar recién formado con la aplicación de aloinjertos de hueso cortical (CB) y matriz desmineralizada de hueso (DBM). Seis muestras de tejido óseo alveolar fueron obtenidas de 5 pacientes (50 ± 6,3 años) después de 6 meses de aplicación de los aloinjertos e inmediatamente antes de la colocación de los implantes dentales. Las muestras fueron fijadas (formaldehído tamponado, pH 7,2), descalcificadas (EDTA al 10%) y procesadas histológicamente (HE y Picro-Sirius) para el análisis histológico. El análisis morfológico reveló la presencia de osteocitos y trabéculas en el tejido óseo neoformado cerca de los aloinjertos y la ausencia de células inflamatorias y alérgicas; los remanentes de CB se ubicaron principalmente en la periferia del tejido óseo y los remanentes de DBM se incorporaron más en el tejido. Se observaron células osteogenitoras alrededor del material restante. La densidad celular no se modificó en el tejido óseo recién formado con la aplicación de ambos aloinjertos en comparación con el tejido óseo maduro. La densidad de los colágenos de tipo I y III presentes en los osteoides intercalados con el resto de los materiales mostró una tendencia a aumentar en las muestras tratadas con DBM. Se concluyó que, debido a las características histológicas observadas, ambos injertos fueron biocompatibles, sin embargo, el hueso tratado con DBM presentó una mejor incorporación y una tendencia al aumento del contenido de colágeno en la región remanente de los aloinjertos.

Subtalar Arthrodesis with Use of Adipose-Derived Cellular Bone Matrix Compared with Autologous Bone Graft: A Multicenter, Randomized Controlled Trial.

UPDATE: This article was updated on November 7, 2019, because of a previous error. On page 1909, in the section entitled "Discussion," the sentence that had read "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs" now reads "Radiographic nonunion rates of 69.2% and 45.6% were observed at 6 months for ACBM and autograft, respectively, as measured on CT scans; however, these nonunion rates do not account for patients who were considered to have attained fusion according to traditional methods, including absence of pain and swelling and presence of arthrodesis on radiographs."An erratum has been published: J Bone Joint Surg Am. 2019 XXX. BACKGROUND: Subtalar arthrodesis effectively treats subtalar joint arthritis when other interventions have failed. Nonunion is a known complication of subtalar arthrodesis, with reported rates ranging from 5% to 45%. Historically, open arthrodesis has been performed with use of autologous bone graft; however, there are inherent disadvantages to autologous bone graft, including donor-site morbidity. Mesenchymal stem cells, when placed on a cellular scaffold, have shown promise as an alternative to autologous bone graft. The purpose of this multicenter, randomized controlled trial was to assess the safety and efficacy of an adipose-derived cellular bone matrix (ACBM) composite made with live cells compared with autograft in subtalar arthrodesis. METHODS: A total of 140 patients were enrolled in a prospective, randomized (1:1) controlled trial performed at 6 clinical sites in the U.S. End points, including radiographic, clinical, and functional outcomes, were assessed over 2 years of follow-up. RESULTS: A total of 109 patients underwent arthrodesis with ACBM (52 patients) and autograft (57 patients). At 6 months, fusion was achieved in 16 patients (30.8%) in the ACBM group and 31 patients (54.4%) in the autograft group as measured on computed tomography (p = 0.024), and in 41 patients (78.8%) in the ACBM group and 50 patients (87.7%) in the autograft group as assessed on clinical and radiographic evaluation (p = 0.213). Quality-of-life outcome measures demonstrated significant functional improvement from baseline for both groups. Fewer cases of serious adverse events occurred in the autograft group (10.5%) compared with the ACBM group (23.1%) (p = 0.078). CONCLUSIONS: In patients who require subtalar arthrodesis, the use of ACBM demonstrated lower rates of radiographic fusion compared with treatment with autograft. The nonunion rate in the autologous group, as measured on computed tomography, was high. Good clinical outcomes were achieved in spite of the high non-union rates. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Application of enamel matrix derivative and deproteinized bovine bone for the treatment of peri-implantitis after decontamination with an ultrasonic scaler: A case report.

RATIONALE: The purpose of this report is to present a case of peri-implantitis with successful regeneration. The surface of the affected dental implant was decontaminated with an ultrasonic scaler and treated with bovine-derived hydroxyapatite and enamel matrix derivative. PATIENT CONCERNS: A 52-year-old male was referred for evaluation of a dental implant placed in the mandibular right second premolar area. DIAGNOSIS: The radiographic evaluation showed the loss of supporting bone around the dental implant. Bleeding upon probing and suppuration were observed, with the deepest probing depth at 6 mm. INTERVENTIONS: The area was firstly treated with a nonsurgical approach. After re-evaluation, a full-thickness flap was elevated. The area was well debrided using various instruments, including curettes and an ultrasonic scaler. The defect area was grafted with bovine-derived hydroxyapatite and enamel matrix derivative. OUTCOMES: Histopathologic evaluation revealed chronic inflammation with fibrosis and calcification. The evaluation at 2 years and 3 months after surgery showed that the prosthesis was functioning well. Bleeding upon probing and suppuration was not noted, and reduction of probing depth was seen, with the deepest depth at 4 mm. The area showed maintenance of graft material with increased radiopacity around the dental implant. LESSONS: In conclusion, a case of peri-implantitis can be successfully treated with bovine-derived hydroxyapatite and enamel matrix derivative after surface decontamination with an ultrasonic scaler.

Cost-Effectiveness Analysis of Demineralized Bone Matrix and rhBMP-2 versus Autologous Iliac Crest Bone Grafting in Alveolar Cleft Patients.

BACKGROUND: The standard of care for patients with alveolar cleft deformities is autologous bone grafting using iliac crest bone graft (ICBG). The combination of demineralized bone matrix with recombinant human bone morphogenetic protein-2 (DBX/rhBMP-2), as a substitute for ICGB, has been shown to have similar bony incorporation within the maxilla without donor-site morbidity. It has been argued that one of the drawbacks of using DBX/rhBMP-2 is the higher cost. The aim of this study was to compare the cost, operative time, and hospital length of stay associated with these two treatment modalities. METHODS: A chart review was conducted for 71 patients who underwent secondary alveolar cleft reconstruction. Forty patients received ICBG and 31 patients underwent reconstruction using DBX/rhBMP-2. Operative costs, operative time, and hospital length of stay were compared between the two groups. RESULTS: The average total operative cost was $6892 in the ICBG surgery population versus $4836 in the DBX/rhBMP-2 population (p < 0.01). Statistically significant decreases in anesthesia, pharmacy, and operating room costs were found in patients who underwent the DBX/rhBMP-2 surgery. Operative time decreased from an average of 97.3 minutes to 67.0 minutes (p < 0.01), and length of inpatient stay decreased from an average of 29.8 hours to 9.3 hours (p < 0.01). CONCLUSION: In the treatment of alveolar cleft deformities, operative material costs were greater in the DBX/rhBMP-2 group but-secondary to decreased hospital, anesthesia, pharmacy, and operating room costs-DBX/rhBMP-2 was more cost-effective than ICBG.