An innovative 3D hydroxyapatite patient-specific implant for maxillofacial bone reconstruction: A case series of 13 patients.

The study aimed to evaluate and discuss the use of an innovative PSI made of porous hydroxyapatite, with interconnected porosity promoting osteointegration, called MyBone Custom® implant (MBCI), for maxillofacial bone reconstruction. A multicentric cohort of 13 patients underwent maxillofacial bone reconstruction surgery using MBCIs for various applications, from genioplasty to orbital floor reconstruction, including zygomatic and mandibular bone reconstruction, both for segmental defects and bone augmentation. The mean follow-up period was 9 months (1-22 months). No infections, displacements, or postoperative fractures were reported. Perioperative modifications of the MBCIs were possible when necessary. Additionally, surgeons reported significant time saved during surgery. For patients with postoperative CT scans, osteointegration signs were visible at the 6-month postoperative follow-up control, and continuous osteointegration was observed after 1 year. The advantages and disadvantages compared with current techniques used are discussed. MBCIs offer new bone reconstruction possibilities with long-term perspectives, while precluding the drawbacks of titanium and PEEK. The low level of postoperative complications associated with the high osteointegration potential of MBCIs paves the way to more extensive use of this new hydroxyapatite PSI in maxillofacial bone reconstruction.

Hydroxyapatite-Coated Screws Versus Titanium Triangular Dowels for Sacroiliac Joint Fusion: Results From a Nonrandomized Prospective Outcome Study.

OBJECTIVE: This is a single-surgeon series that prospectively evaluates the results of sacroiliac joint (SIJ) fusion for patients with SIJ dysfunction using hydroxyapatite-coated screws (HACSs) compared with titanium triangular dowels (TTDs). METHODS: A total of 113 patients underwent SIJ fusion surgery between 2013 and 2018 at the University Hospital Llandough to treat symptomatic SIJ dysfunction not responding to nonoperative measures. Of the 113 patients, 40 were treated with HACSs and 73 with TTDs. Patient-reported outcomes measures (PROMs) were collected preoperatively and at 12 months postoperatively, including the 36-item short-form health survey, Oswestry disability index, EuroQol-5D-5L, and Majeed pelvic score. Patients with ongoing symptoms were followed up beyond the study period. RESULTS: Of the 113 patients, 33 completed follow-up in the HACS group compared with 61 in the TTD group. Both groups had comparable preoperative PROMs; however, the postoperative PROMs were significantly better in the TTD group. Additionally, 21 patients (63%) in the HACS group had radiological evidence of screw lysis compared with 5 patients (9%) in the TTD group. A subgroup analysis revealed less significant improvement in PROMs for patients with screw lysis compared with those without. Four patients were offered further revision surgery. CONCLUSIONS: Minimally invasive SIJ fusion has been shown to have good clinical outcomes for select patients. However, our experience shows that HACSs are associated with a high rate of screw lysis and poorer patient outcomes compared with TTDs. Therefore, we recommend the use of TTDs instead of HACSs for SIJ fusion surgery.

Comparative analysis of the physical, chemical, and microbiological properties of Ti-6Al-4V disks produced by different methods and subjected to surface treatments.

STATEMENT OF PROBLEM: To improve the osseointegration of dental implants and reduce microbiological growth, different micro- and nanoscale surface topographies can be used. PURPOSE: The purpose of this in vitro study was to evaluate the influence of Ti-6Al-4V with 4 surfaces, machined (DU), machined+hydroxyapatite (DUHAp), machined+acid-alkali treatment (DUAA), and additive manufacturing (DMA), on the physical, chemical, and microbiological properties. MATERIAL AND METHODS: The topography of Ti-6Al-4V disks with the 4 surfaces was evaluated by scanning electron microscopy (SEM), the chemical composition by energy dispersive X-ray spectroscopy (EDS), and the crystalline structure by X-ray diffraction (XRD). Physical and chemical properties were analyzed by using wettability and surface free energy, roughness, and microbial adhesion against Staphylococcus aureus by colony forming units (CFU). One-way ANOVA analysis of variance and the Tukey multiple comparisons test were applied to evaluate the data, except CFU, which was submitted to the Kruskal-Wallis nonparametric test (α=.05). RESULTS: DU photomicrographs showed a topography characteristic of a polished machined surface, DUHAp and DUAA exhibited patterns corresponding to the surface modifications performed, and in DMA the presence of partially fused spherical particles was observed. The EDS identified chemical elements inherent in the Ti-6Al-4V, and the DUHAp and DUAA disks also had the ions from the treatments applied. XRD patterns revealed similarities between DU and DMA, as well as characteristic peaks of hydroxyapatite (HA) in the DUHAp disk and the DUAA. Compared with DU and DMA the DUHAp and DUAA groups showed hydrophilic behavior with smaller contact angles and higher surface free energy (P<.05). DMA showed a higher mean value of roughness, different from the others (P<.05), and a higher CFU for S. aureus (P=.006). CONCLUSIONS: DUHAp and DUAA showed similar behaviors regarding wettability, surface free energy, and bacterial adhesion. Among the untreated groups, DMA exhibited higher roughness, bacterial adhesion, and lower wettability and surface free energy.

Osseointegration of a hydroxyapatite-coated stem in femoral neck fractures in the over-80 s.

PURPOSE: In the over-80 s, femoral bone is often osteoporotic and unlikely to be conducive to periprosthetic bone rehabitation. This observation often leads to cemented fixation for hemiarthroplasty in femoral neck fracture. Hydroxyapatite is a bioactive coating that has already demonstrated its osteoinductive properties. Our hypothesis is that hydroxyapatite enables prosthetic osseointegration in patients over 80, as well as periprosthetic cortical thickening. The objective was to evaluate the osseointegration of a hydroxyapatite-coated femoral stem in femoral neck fractures in the over-80 s, and the evaluation of the periprosthetic bone regeneration permitted by hydroxyapatite. METHODS: This was a retrospective study. Osseointegration and periprosthetic bone regeneration were assessed on pre-operative, immediate post-operative and last follow-up radiographs with Engh score, O-SS score, cortical index, Canal Bone Ration (CBR) and Canal Fill Ratio (CFR). RESULTS: One hundred and forty-six patients were included. At last follow-up, 99.3% (n = 145) of stems were osseointegrated. The mean Engh score was 19.9 [SD 3.1]. The mean O-SS score was 19.1 [SD 2.4], corresponding to very good osseointegration. The mean CBR at last follow-up was 0.48 [SD 0.07], corresponding to a non-osteoporotic femur. There was a significant difference with pre-operative CBR (p < 0,001). The pre-operative cortical index and the index at the last follow-up were significantly different for all levels of measurement (p < 0,001). The CFR at last follow-up was also significantly different with the post-operative CFR (p < 0,001). CONCLUSION: This study shows the value of using a hydroxyapatite-coated stem on senile, osteoporotic bone to improve cortical thickness along the entire length of femoral bone.

A randomized clinical trial of phycogenic materials for sinus grafting with hydroxyapatite versus biphasic calcium phosphate: 2 years clinical outcomes.

OBJECTIVES: To assess in a prospective randomized trial two phycogenic bone substitutes-biphasic calcium phosphate (BCP) versus almost pure hydroxyapatite (HA)-for their volume stability and clinical implications after sinus floor elevation (SFE). MATERIALS AND METHODS: Twenty patients requiring lateral-window SFE 6 months prior to implant surgery were randomized to a BCP or HA group. As primary outcome, the grafts were analyzed for volume stability, using four cone-beam computed tomography scans obtained immediately/6/12/24 months after SFE. Secondary outcomes were implant survivval, success, periotest values, oral-health-related quality of life (OHIP-G14), and pain (VAS). RESULTS: Kolmogorov-Smirnov goodness-of-fit test revealed normal distribution of samples (p = .200). At 6/12/24 months, the augmented volumes decreased to 96/92/90% (HA) or 99/96/96% (BCP). Volume changes were significantly a factor of time (p < .001; generalized linear model with repeated measures) and reached significantly lower values in HA group (p = .018). Significant intergroup difference in volume losses was notable at 24 months (p = .021; t-test for independent samples). Periotest values decreased from -3/-4.1 (HA/BCP) after implant placement to -6.3/-4.5 (HA/BCP) after 6 months. OHIP scores diverged at 2 months (HA: 9.5; BCP: 5.2) and largely resolved by 24 months (HA: 1.3; BCP: 1.9). VAS scores were comparable, 2.2 at 1 week after SFE being their highest mean level. CONCLUSIONS: After 2 years, both groups experienced no biological or technical complications, demonstrating a consistent healing trajectory without notable symptoms. Although no significant differences were observed in implant stability and survival, BCP demonstrated higher volume stability than HA.

Biological performance of a novel bovine hydroxyapatite in a guided bone regeneration model: A preclinical study in a mandibular defect in dogs.

OBJECTIVES: This preclinical model study aims to evaluate the performance and safety of a novel hydroxyapatite biomaterial (Wishbone Hydroxyapatite, WHA) on guided bone regeneration compared to a commercially available deproteinized bovine bone mineral (Bio-Oss, BO). MATERIAL AND METHODS: Twenty-four beagle dogs were allocated to three timepoint cohorts (4, 12, and 26 weeks) of eight animals each. In all animals, four critical-sized, independent wall mandibular defects were created (32 defects/cohort). Each animal received all four treatments, allocated randomly to separated defects: WHA + collagen membrane (M), BO + M, no treatment (Sham, Sh), and Sh + M. At each timepoint, the specimens were harvested for histologic and histomorphometric analyses to determine the newly formed bone and osteoconductivity. RESULTS: At 4 weeks, bone regeneration was significantly higher for WHA + M (46.8%) when compared to BO + M (21.4%), Sh (15.1%), and Sh + M (23.1%) (p < 0.05); at 12 and 26 weeks, regeneration was similar for WHA and BO. Bone-to-material contact increased over time similarly for WHA + M and BO + M. From a safety point of view, inflammation attributed to WHA + M or BO + M was minimal; necrosis or fatty infiltrate was absent. CONCLUSIONS: WHA + M resulted in higher bone regeneration rate than BO + M at 4 weeks. Both BO + M and WHA + M were more efficient than both Sh groups at all timepoints. Safety and biocompatibility of WHA was favorable and comparable to that of BO.

The Use of Nano-Hydroxyapatite (NH) for Socket Preservation: Communication of an Upcoming Multicenter Study with the Presentation of a Pilot Case Report.

Background and Objectives: The use of biomaterials in dentistry is extremely common. From a commercial perspective, different types of osteoconductive and osteoinductive biomaterials are available to clinicians. In the field of osteoconductive materials, clinicians have biomaterials made of heterologous bones at their disposal, including biomaterials of bovine, porcine, and equine origins, and biomaterials of natural origin, such as corals and hydroxyapatites. In recent years, it has become possible to synthesize nano-Ha and produce scaffolds using digital information. Although a large variety of biomaterials has been produced, there is no scientific evidence that proves their absolute indispensability in terms of the preservation of postextraction sites or in the execution of guided bone regeneration. While there is no scientific evidence showing that one material is better than another, there is evidence suggesting that several products have better in situ permanence. This article describes a preliminary study to evaluate the histological results, ISQ values, and prevalence of nano-HA. Materials and Methods: In this study, we planned to use a new biomaterial based on nanohydroxyapatite for implantation at one postextraction site; the nano-HA in this study was NuvaBONE (Overmed, Buccinasco, Milano, Italy). This is a synthetic bone graft substitute that is based on nanostructured biomimetic hydroxyapatite for application in oral-maxillofacial surgery, orthopedics, traumatology, spine surgery, and neurosurgery. In our pilot case, a patient with a hopeless tooth underwent extraction, and the large defect remaining after the removal of the tooth was filled with nano-HA to restore the volume. Twelve months later, the patient was booked for implant surgery to replace the missing tooth. At the time of the surgery, a biopsy of the regenerated tissue was taken using a trephine of 4 mm in the inner side and 8 mm deep. Results: The histological results of the biopsy showed abundant bone formation, high values of ISQ increasing from the insertion to the prosthetic phase, and a good reorganization of hydroxyapatite granules during resorption. The implant is in good function, and the replaced tooth shows good esthetics. Conclusions: The good results of this pilot case indicate starting the next Multicentric study to have more and clearer information about this nanohydroxyapatite (NH) compared with control sites.

Synthesis and characterization of hydroxyapatite nanoparticles and their effects on remineralization of demineralized enamel in the presence of Er,Cr: YSGG laser irradiation.

BACKGROUND: This study aims to synthesize and characterize hydroxyapatite nanoparticles (nano-HA) and evaluate their effects on the remineralization of demineralized enamel in the presence to Er,CR: YSGG laser irradiation. MATERIALS AND METHODS: Enamel specimens from 44 human molars were divided into four groups: control, demineralized enamel, demineralized enamel treated with nano-HA, and demineralized enamel treated with nano-HA followed by Er,Cr:YSGG laser irradiation (0.5, 20 Hz, 60 µs, 20 s). Vickers microhardness test was used to evaluate the enamel surface hardness. The morphology and chemistry of enamel surfaces were assessed using scanning electron microscopy (SEM) and Raman spectroscopy, respectively. RESULT: The result of this study showed that the application of Er,CR: YSGG laser irradiation to demineralized enamel treated with nano-HA had the highest impact on its microhardness. CONCLUSION: ER,CR: YSGG laser irradiation promotes enamel remineralization after treatment with nano HA.

Comparison of Nanocrystalline Hydroxyapatite Bone Graft with Empty Defects in Long Bone Fractures: A Retrospective Case-Control Study.

BACKGROUND The regeneration of bone defects is indicated to restore lost tissue mass and functionality. Ostim®, an absorbable nanocrystalline hydroxyapatite (NCHA) paste, is indicated to enhance bone regeneration in bone defects due to trauma or surgery. This retrospective study of 110 patients with long-bone fracture defects presenting at a single trauma center between 2010 and 2012 aimed to compare outcomes with and without the use of Ostim® absorbable nanocrystalline hydroxyapatite paste. MATERIAL AND METHODS The study encompassed fractures in 110 patients - 55 patients received any defect augmentation (ED) and 55 patients were treated with NCHA augmentation. Fractures were located at the distal radius (66.4%, n=73), proximal humerus (5.5%, n=6), and proximal tibia (28.2%, n=31). Evaluating the clinical follow-up, the study encompassed post-surgery complications (eg, non-unions, infection). Bone healing was evaluated by conventional radiographs. RESULTS Postoperative complications occurred in 45.5% of patients regardless of the treatment (P=1.0). The non-union rate in both groups was 5.5% (n=8, P=1.0), and the risk for infection was lower in the NCHA group (3.6%, ED: n=3, NCHA: n=1, p=0.62). Patients suffered open fractures were treated in the NCHA group (100%, n=7, P=0.003). Radiological assessment demonstrated comparable healing of the fracture border, fracture gap, and articular surface (P>0.05). CONCLUSIONS The findings from this retrospective study support previous studies that have shown Ostim® absorbable nanocrystalline hydroxyapatite paste enhances outcomes and reduces the risk of complications when used to repair bone defects in long-bone fractures in trauma patients. NCHA paste augmentation is suitable for use in traumatic long-bone fractures.

Ossification and Bone Regeneration in a Canine GBR Model, Part 2: Glycated Cross-Linked Collagenated Alloplastic Hydroxyapatite Scaffold vs Non-Cross-Linked Collagenated Xenographic Bone Hydroxyapatite.

PURPOSE: To compare bone substitutes composed of glycated collagen with synthetic micro-sized (1 to 10 µm) hydroxyapatite (OB) vs non-cross-linked collagen matrix with large-particle (250 to 1,000 µm) bovine-derived hydroxyapatite (BOC). MATERIALS AND METHODS: The P1 to P4 premolars were bilaterally extracted from the mandibles of 19 Beagle dogs. After 21 days, osteotomies were created in each dog that received OB or BOC and were covered with a collagen membrane or were left untreated. The animals were randomly divided into three groups based on sacrifice time (4, 12, or 24 weeks). The right and left hemimandibles were trimmed to facilitate imaging and histology, and all tissues were placed in 10% neutral-buffered formalin. Microcomputed tomography (MicroCT 40 Scanner, Scanco) was used to analyze bone sections. Bone volume, residual material volume, and bone mineral density were determined for each treatment site (OB and BOC) based on a volume of interest that encompassed the original defect. Additionally, blinded histopathologic assessment (based on the ISO 10993-6 scoring system) and histomorphometry were performed on sections ground to < 100 µm thick and stained with Stevenel's blue. RESULTS: No clinical side effects were noted. No statistical differences were observed for OB vs BOC regarding the mineral volume percentage. Compared to OB, BOC had significantly higher mean mineralization densities at 12 weeks (P < .01), but this difference did not extend to 24 weeks. For residual grafting material, bone maturation, alveolar ridge restoration, and inflammatory response, OB showed a residual amount of bone graft and no statistical differences compared to BOC. CONCLUSION: Both OB and BOC represent valid treatment options for critically sized bone defects. Both bone fillers outperformed the sham-operated, ungrafted (empty) control, demonstrating statistically improved bone growth and ridge restoration.

Application of biodegradable Patient-specific scaffolds for maxillofacial bone regeneration: a scoping review of clinical studies.

This study aimed to systematically review clinical studies in which biodegradable patient-specific scaffolds were used for bone regeneration. Studies in which biodegradable scaffolds were fabricated through computer-assisted design and computer-assisted manufacturing (CAD-CAM) procedures were included. Those that applied non-biodegradable materials or used biodegradable materials in a condensable powder or block form were excluded. Among a total of 26 included studies, 11 used customised allogeneic bone blocks, five used polycaprolactone (PCL)-containing scaffolds, four used hydroxyapatite (HA) scaffolds, and four biphasic calcium phosphate (BCP). The majority of the studies applied scaffolds for minor intraoral defects. All the large defects were reconstructed with polymer-containing scaffolds. Results of the included studies showed partial to complete filling of the defect following the application of biodegradable scaffolds. However, limited graft exposure was reported when using PCL, BCP, and HA scaffolds. Tissue engineering can be considered a potential method for the treatment of maxillofacial bone defects. However, more evidence is required, especially for the application of biodegradable scaffolds in large defects.

A novel treatment based on powder jet deposition technique for dentin hypersensitivity: a randomized controlled trial.

BACKGROUND: This study aimed to evaluate the efficacy and safety of dentin hypersensitivity (DH) treatment using a newly developed device based on a powder jet deposition (PJD) technique that creates a hydroxyapatite (HAP) layer on the dentin surface, thereby alleviating the hypersensitivity. The effect of the PJD treatment was compared with that of conventional treatment using Teethmate Desensitizer (TMD; calcium-phosphate containing material with TTCP (Ca4(PO4)2O) and DCPA (CaHPO4)), which has been used clinically in Japan with well-confirmed effectiveness. MATERIALS AND METHODS: A randomized controlled trial was conducted including 35 patients who had symptoms of DH in two or more quadrants. Two test teeth were selected per patient (70 teeth in total) and randomly assigned to PJD or TMD treatment. The efficacy was evaluated using the improvement rate for air and scratch pain according to the scores obtained via visual analog scale 12 weeks after treatment. The safety assessment was performed focusing on gingival index (GI) and spontaneous pain. The t-test was used to analyze the non-inferiority of PJD treatment compared to TMD treatment. RESULTS: The improvement rate of air pain was 69.0% for PJD and 69.7% for TMD. The improvement rate of scratch pain was 80.8% for PJD and 81.7% for TMD. Non-inferiority with a margin of 10% was not observed for both air and scratch pain. No change was observed in GI from baseline and the improvement rate of spontaneous pain for PJD was higher than that for TMD. CONCLUSION: Non-inferiority of PJD to TMD treatment was not observed in this study; however, it was not statistically demonstrated, and the results were thus interpreted as inconclusive. PJD did improve the DH symptoms, as did TMD. PJD's therapeutic effect was most likely attributable to the deposition of a HAP layer on the tooth surface, which would alleviate hypersensitivity for at least 12 weeks without causing severe adverse events. TRIAL REGISTRATION: UMIN-CTR. ID: UMIN000025022. date: 02/12/2016.

Evaluating and Comparing the Effectiveness of Nano-HA and HA + ß-TCP with A-PRF Clinically and Radiographically in the Treatment of Human Infrabony Defects.

AIM: To evaluate and compare the effectiveness of nanocrystalline hydroxyapatite (NcHA) with advanced platelet-rich fibrin (A-PRF) and hydroxyapatite-reinforced beta tricalcium phosphate (HA + ß-TCP) with A-PRF in the treatment of human infrabony defects clinically and radiographically using cone-beam computed tomography (CBCT). MATERIALS AND METHODS: There were a total of 28 defects, with 14 defects in the test and control groups, respectively. There were total 28 patients were involved in the study. The test group (group A) was treated with NHA and A-PRF, while the control group (group B) was treated with HA + ß-TCP and A-PRF. Bone defect fill was the primary result of the investigation. Periodontal pocket depth (PPD), R-CAL, papillary bleeding index (PBI), and PI were the secondary outcome. Clinical and radiographic measurements were recorded at baseline and 6 months postoperatively. RESULTS: No significant difference was observed between the two groups in terms of PPD reduction (4.64 ± 0.74 mm vs 4.07 ± 0.99 mm), clinical attachment loss (CAL) gain (4.64 ± 0.74 mm vs 3.92 ± 0.99 mm) and radiographic defect depth reduction (2.41 ± 0.32 mm vs 2.40 ± 0.27 mm) for test and control groups, respectively. CONCLUSION: At 6-month post-surgery, both treatment modalities demonstrated statistically significant improvements with regard to CAL gains, PPD reduction, and reduction in radiographic defect depth. CLINICAL RELEVANCE: The NcHA and HA + ß-TCP with A-PRF is a novel material used in the treatment of infrabony defect for periodontal regeneration. The NcHA and HA + ß-TCP with A-PRF need to consider biomaterials for bone defect fill.

Detection of artificial enamel caries-like lesions with a blue hydroxyapatite-binding porosity probe.

OBJECTIVES: This in vitro study investigated the ability of a blue protein-based hydroxyapatite porosity probe to selectively detect artificial enamel caries-like lesions of varying severities. METHODS: Artificial caries-like lesions were formed in enamel specimens using a hydroxyethylcellulose-containing lactic acid gel for 4/12/24/72 or 168 h. One untreated group was used as a control. The probe was applied for 2 min and unbound probe rinsed off with deionized water. Surface color changes were determined spectrophotometrically (L*a*b* color space) and with digital photography. Lesions were characterized using quantitative light-induced fluorescence (QLF), Vickers surface microhardness, and transverse microradiography (TMR). Data were analyzed using one-way ANOVA. RESULTS: Digital photography did not reveal any discoloration in unaffected enamel. However, all lesions stained blue with color intensity positively correlated with demineralization times. The color data reflected similar trends: lesions became significantly darker (L* decreased) and bluer (b* decreased), while overall color differences (ΔE) increased significantly after probe application (4-h lesion, mean±standard deviation: ΔL*=-2.6 ± 4.1/Δb*=0.1 ± 0.8/ΔE=5.5 ± 1.3 vs. 168-h lesion: ΔL*=-17.3 ± 1.1/Δb*=-6.0 ± 0.6/ΔE=18.7 ± 1.1). TMR analysis revealed distinct differences in integrated mineral loss (ΔZ) and lesion depth (L) between demineralization times (4-h lesion: ΔZ=391±190 vol%min × µm/L = 18.1 ± 10.9 µm vs. 168-h lesion: ΔZ=3606±499 vol%min × µm/L = 111.9 ± 13.9 µm). QLF and microhardness were also able to differentiate between demineralization times. L and ΔZ strongly correlated (Pearson correlation coefficient [r]) with Δb* (L vs. Δb*: r=-0.90/ΔZ vs. Δb*: r=-0.90), ΔE (r = 0.85/r = 0.81), and ΔL* (r=-0.79/r=-0.73). CONCLUSION: Considering the limitations of this study, the blue protein-based hydroxyapatite-binding porosity probe appears to be sufficiently sensitive to distinguish between unaffected enamel and artificial caries-like lesions. CLINICAL SIGNIFICANCE: Early detection of enamel caries lesions remains one of the most critical aspects in the diagnosis and management of dental caries. This study highlighted the potential of a novel porosity probe in detecting artificial caries-like demineralization by objective means.

Sinus floor augmentation using crestal approach in conjunction with hydroxyapatite/cross-linked collagen sponge: A pilot study.

BACKGROUND: Different biomaterials were suggested for sinus floor augmentation (SFA). Recently, new materials were launched showing true bone formation without remnants. PURPOSE: The aim of this prospective study was to evaluate an hydroxyapatite-based, sugar cross-linked collagen sponge (OSSIX™ Bone) in transcrestal SFA (t-SFA). MATERIALS AND METHODS: Twenty-four patients with edentulous posterior maxilla and residual bone height (RBH) >4 mm underwent t-SFA with OSSIX™ Bone as grafting material and simultaneous implant placement. The implant Stability Quotient (ISQ) was measured by resonance frequency analysis (RFA) directly after implant insertion and at 6 months. Differences in bone height (BH) and volume were determined in CBCT and x-rays at baseline versus 1 year of follow-up. Graft volume was evaluated by tridimensional reconstructions. Linear regression analysis was used to evaluate the effect of bucco-palatal sinus dimension, RBH, and length of the implant protruding (PIL) into the sinus, on the graft height (GH) changes up to 1 year, and on the graft volume at 1 year. Autocorrelation between time lag and augmented bone volume was evaluated through time series analysis correlograms. Health-related quality-of-life outcomes were captured. RESULTS: Twenty-two patients completed the study. The mean RBH measured at baseline was 5.81 ± 2.2 mm. The mean graft volume was 1085.8 ± 733.4 mm3 . The mean GH, measured in the immediate post-operative period, at 6 and 12 months respectively, was 7.24 mm ±1.94; 6.57 mm ± 2.30; 5.46 mm ± 2.04. The mean ISQ measured after the implant placement was 62.19 ± 8.09, and 6 months later was 76.91 ± 4.50. There was a significant correlation between buccolingual dimension and graft volume at 1 year. Neither buccolingual volume nor RBH had a significant effect on GH change, while the PIL showed a significant positive correlation (P = 0.02 and P = 0.03 at 6 and 12 months, respectively). The correlograms indicated no significant correlation, meaning that there is no tendency for graft volume to increase or decrease over time, therefore suggesting graft stability, at least up to one year of follow-up. 86% of patients had no chewing interference. CONCLUSION: Within the limitations of the study, OSSIX™ Bone could be considered a valid material for SFA due to its manageability and its positive results in promoting new bone formation with long-term stability. T-SFA is confirmed as a less invasive and less painful method.

The evolving field of regenerative aesthetics.

BACKGROUND: Regenerative aesthetics (RA) is an emerging subfield based on many of the principles of regenerative medicine (RM). In order to ensure that the development of regenerative aesthetics is based on accepted regenerative concepts and to optimize treatment strategies, it is important to establish clear definitions, fundamental aims and consider the impact of the predominant RA tissue environment RM focuses on the regeneration of injured or diseased tissue, while RA aims to restore youthful properties to aging, senescent tissue. The distinction is key in understanding how best to develop treatments for these different goals. AIMS AND METHODS: The current review suggests key concepts, definitions, and foundations of regenerative aesthetic approaches and examines current evidence supporting this. It considers the importance of the aging tissue environment, the essential regenerative goals of restored tissue structure and function and introduces the concept of regenerative scaffolds with a focus on CaHA. Current techniques in the field and promising future directions are also discussed. CONCLUSION: Regenerative aesthetics is an evolving subfield of regenerative medicine. Establishing clear definitions, identifying the challenges of the aging soft tissue environment and re-evaluating current evidence in light of regenerative goals are vital for the continuing evolution of this medical field.

EFFICACY OF OSSEIN-HYDROXYAPATITE COMPLEX AS A PHARMACOLOGICAL CORRECTOR OF BONE LOSS (REVIEW).

The problem of osteoporosis is relevant due to the high frequency of its prevalence throughout the world. Complex mechanisms for maintaining bone mass biomass require various options for their pharmacological correction, so the range of proposed drugs is expanding. Among the debatable indications for the pharmacological correction of osteopenia and osteoporosis, the effectiveness and safety of the ossein-hydroxyapatite complex (OHC), which contributes to the preservation of mitogenic effects on bone cells, are specified. The literature review dis-cusses aspects of the use of OHC: in traumatology and surgery for problematic complicated fractures, the impact of both excess and deficiency of hormonal regulators in postmenopausal women or in conditions of long-term pharmacotherapy with glucocorticoids, age-related as-pects from childhood to old age correction by OHC of accompanying bone tissue imbalance in pediatrics and geriatrics are considered, as well as the mechanisms of the positive effect of OHC in experimental data are clarified. Among the unresolved debatable issues of clinical protocols, various dose aspects, duration of therapy and clarification of indications in accord-ance with the requirements of personalized medicine continue to remain.

Clinical and radiographic evaluation of platelet-rich fibrin and bone graft material (ß-tricalcium phosphate + hydroxyapatite) in the treatment of intrabony defects of periodontitis patients: a randomized controlled trial.

OBJECTIVE: The present study aimed to assess the clinical and radiographic effect of a bone graft material (ß-tricalcium phosphate + hydroxyapatite) alone and in combination with platelet-rich fibrin in intrabony defects of periodontitis patients. METHOD AND MATERIALS: This 6-month randomized controlled clinical trial was carried out in 42 intrabony periodontal defects (average age 40 years). Intrabony defects ≥ 3 mm along with associated probing depth of ≥ 5 mm following phase 1 periodontal therapy were treated either with open flap debridement with bone graft (ß-tricalcium phosphate + hydroxyapatite; control group) or open flap debridement with bone graft plus platelet-rich fibrin membrane (test group). Individual customized acrylic stents with grooves were used to ensure reproducible and repeatable measurements of clinical and radiographic parameters, including probing pocket depth (PPD), relative clinical attachment level (RCAL), gingival marginal level (GML), vertical bone defect fill (VHD), and area of intrabony defects (AOD) on intraoral periapical radiographs. Clinical attachment level (CAL) gain was considered as primary outcome and PPD reduction and radiographic bone fill as secondary outcomes. RESULTS: The preoperative Plaque Index, RCAL, GML, PPD, VHD, and AOD in the control group were 1.06 ± 0.08, 11.57 ± 2.29 mm, 5.24 ± 1.89 mm, 6.29 ± 1.52 mm, 14.36 ± 2.65 mm, and 7.79 ± 4.39 mm2, respectively. After 6 months these were 1.08 ± 0.14, 9.34 ± 2.54 mm, 5.81 ± 2.20 mm, 3.52 ± 0.93 mm, 12.64 ± 2.34 mm, and 5.34 ± 3.2 mm2, respectively. The preoperative PI, RCAL, GML, PPD, VHD, and AOD in the experimental group were 1.14 ± 0.05, 12.19 ± 2.86 mm, 4.38 ± 1.63 mm, 7.81 ± 2.6 mm, 13.46 ± 3.42 mm, and 10.31 ± 8.71 mm2, respectively. After 6 months these were 1.09 ± 0.12, 8.62 ± 2.62 mm, 4.90 ± 1.79 mm, 3.71 ± 1.68 mm, 10.10 ± 2.07 mm, and 4.38 ± 2.67 mm2, respectively. After 6 months of evaluation both the groups showed a significant reduction in PPD (P < .001) and a significant gain in CAL (P < .001), as well as significant improvement in radiographic VHD fill and AOD changes. Again, the test group showed significant changes (P < .001) over the control group considering the same outcomes. CONCLUSION: With the study limitations in mind, it can be concluded that for the treatment of intrabony defects with the bone graft material (ß-tricalcium phosphate + hydroxyapatite; Biograft, IFGL Bio Ceramics) or the same bone graft with platelet-rich fibrin membrane results in statistically significant improvement in clinical (CAL and PPD) and radiographic (VHD and AOD) parameters, the latter having highly significant benefits. However, the bone graft material requires improvement.

The effects of nano-hydroxyapatite/polyamide 66 scaffold on dog femoral head osteonecrosis model: a preclinical study.

The lack of mechanical support in the bone tunnel formed after CD often results in a poor therapeutic effect in ONFH. The n-HA/P66 has excellent biocompatibility and mechanical properties and has been widely used in bone regeneration. The present study aimed to evaluate the effects of n-HA/P66 scaffold treatment in a dog model of ONFH. A FEA was performed to analyze the mechanical changes in the femoral head after CD and n-HA/P66 scaffold or tantalum rod implantation. Fifteen male beagles were selected to establish the model of ONFH by liquid nitrogen freezing method, and the models were identified by x-ray and MRI 4 weeks after modeling and randomly divided into three groups. Nine weeks later, femoral head samples were taken for morphology, micro-CT, and histological examination. The FEA showed that the n-HA/P66 scaffold proved the structural support in the bone tunnel, similar to the tantalum rod. The morphology showed that the femoral head with n-HA/P66 implantation is intact, while the femoral heads in the model group and CD group are collapsing. Moreover, the micro-CT results of the n-HA/P66 scaffold group were better than the model group and the CD group, and the interface between the n-HA/P66 scaffold and bone tissue is blurred. Furthermore, the histological result also verifies the alterations in micro-CT, and bone tissue grows in the bone tunnel with n-HA/P66 scaffold implanted while few in the CD group. The CD results in a lack of mechanical support in the femoral head subchondral bone and bone tunnel high stress. The n-HA/P66 scaffold implantation can provide mechanical support and relieve high stress induced by CD. The n-HA/P66 scaffold can treat femoral head necrosis and provide the bone tissue growth scaffold for the femoral head after CD to promote bone tissue regeneration.

Can hydroxyapatite charged collagen sponge help reduce perioperative blood loss in adolescent idiopathic scoliosis surgery? Preliminary results in 68 patients.

PURPOSE: Patient blood management has been recently emphasized to avoid perioperative blood transfusion in AIS surgery. Hydroxyapatite charged collagen sponge (HCS) is a bone substitute material made of collagen and ceramized hydroxyapatite, with associated haemostatic properties. The goal of this study was to assess the impact of HCS in the perioperative blood loss in AIS surgery. METHODS: After IRB approval, all AIS patients undergoing primary correction were prospectively included over a 15-month period. Patients receiving HCS at the end of the procedure were compared to a control group (matched for age, gender, and fusion levels) without any haemostatic agent or bone substitute. The same perioperative blood saving strategies were used in both groups. Two subfascial drains were used for 48 h in all patients. Perioperative blood loss and transfusion rates were analysed. RESULTS: A total of 34 patients were included in each group. No difference in drainage volume was observed at day 1, but the reduction was statistically different at day 3 (1135 mL [800-1640] versus 930 [480-1510], p = 0.028, 0.63 ml/Kg/h [0.4-0.92] versus 0.46 [0.29-0.7], p = 0.042). Multivariate analysis found that the use of HCS was associated with a decrease in the postoperative blood loss (OR = 1.17 [1.10-1.25]). The transfusion rate was lower in the HCS group [0 (0% vs. 3(8.8%), p = 0.076)]. No infection occurred, and no complication was reported. CONCLUSION: With 27% reduction in drain volume, hydroxyapatite charged collagen sponge can be considered as a blood salving strategy in AIS surgery. The role of the biomaterial in fusion rate still needs to be further assessed.