Molecular insights and the role of 18F-FDG-PET/CT in the diagnosis of spinal gliomas.

BACKGROUND: In recent years, molecular findings on spinal gliomas have become increasingly important. This study aimed to investigate the role of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) in the diagnosis of spinal glioma. METHODS: This study included patients diagnosed with spinal cord glioma who underwent 18F-FDG-PET examination at the Department of Neurosurgery, Nagoya University Hospital between January 2016 and November 2023. The gliomas were divided into two groups, high-grade and low-grade, based on pathological and molecular studies. The maximum standardized uptake values (SUVmax) of the tumors were quantified and subsequently represented using receiver operating characteristic (ROC) curves. RESULTS: Eighteen participants were included in this study. Of the participants, seven had high-grade glioma with an SUVmax of 6.76 ± 0.72, and eleven had low-grade glioma with an SUVmax of 4.02 ± 1.78, and a statistically significant difference between the two groups. The ROC curve delineated an SUVmax cutoff value of 5.650, with an area under the curve (AUC) of approximately 0.909. Based on the cutoff value, the results of the diagnostic performance rendered a sensitivity and negative predictive value of 1.0, whereas the specificity and positive predictive value were 0.909 and 0.875, respectively. CONCLUSIONS: The present study shows that 18F-FDG-PET exhibits a markedly sensitive and negative predictive value in the assessment of spinal gliomas. Additionally, these findings have potential implications for the qualitative assessment of spinal gliomas using 18F-FDG-PET/CT. This imaging modality may be useful for making timely treatment decisions in situations where a detailed diagnosis by molecular analysis is not possible.

Comparison of Skeletal Stability after Le Fort I Osteotomy With Bone Fixation Using Biodegradable and Titanium Systems: A Retrospective Study.

The titanium osteosynthesis system used for fixing bone segments after maxillary osteotomy provides reliable outcomes owing to its biocompatibility and adequate strength. In addition, several studies have evaluated the skeletal stability after maxillary osteotomy with fixation using a biodegradable system. However, the indications for applying a biodegradable system after maxillary osteotomy remain controversial. Therefore, this study aimed to compare the long-term skeletal stability of bone segments after maxillary osteotomy with bone fixation using biodegradable and titanium osteosynthesis systems and to assess the usefulness of a biodegradable osteosynthesis system. Patients who underwent Le Fort I osteotomy of the maxilla to correct jaw deformities between April 2008 and March 2021 were included in this study. A total of 45 patients were included, with 28 in the biodegradable osteosynthesis system group and 17 in the titanium group. Cephalometric and computed tomography analyses were performed to evaluate the skeletal stability of the bone segments after maxillary osteotomy with bone fixation using biodegradable or titanium osteosynthesis systems. The maxillary segment was repositioned anteriorly with a clockwise rotation. Skeletal stability was similar between the biodegradable and titanium osteosynthesis systems. Segmental changes occurred mainly in the first 6 months after surgery, and the segment was completely stable between 6 and 12 months after surgery. This study revealed no significant differences in skeletal stability after maxillary osteotomy between the biodegradable and titanium osteosynthesis systems. However, the findings in this study should be interpreted with caution owing to the small sample size and small amount of maxillary-segment movement.

[Differential Diagnosis between Spinal Degenerative Disorder and Peripheral Nerve Entrapment Disease].

In the surgical treatment of spinal degenerative disorders, neural function improves to some extent upon successful neural decompression. However, we have witnessed cases with poor postoperative results. The causes include surgical procedure issues, such as insufficient decompression of neural tissues and overlooking sites to be decompressed, and neurological misdiagnosis of other causative lesions or multiple lesions. Here, as necessary knowledge for spine surgeons dealing with spinal cord degenerative disorders to prevent poor surgical results, we have discussed the differentiation of peripheral nerve entrapment neuropathy from spinal degenerative disorders. Specifically, we have focused on L5 radiculopathy or common peroneal nerve entrapment disorder and C8 radiculopathy or thoracic outlet syndrome or ulnar nerve entrapment neuropathy, which are difficult to distinguish, and have explained the difference in their neurological symptoms from an anatomical perspective. We have also described the differential diagnosis of drop fingers, which is one of the neurological symptoms, and have mentioned the possibility of diseases managed by neurologists, which neurosurgeons should know about.

Remote ischemic preconditioning protects human neural stem cells from oxidative stress.

In previous clinical trials, we showed that remote ischemic preconditioning (rIPC) reduced myocardial damage in children undergoing treatment for congenital heart defects and postoperative renal failure in patients undergoing abdominal aortic aneurysm surgery. In rabbit experiments, pre-treatment with plasma and plasma dialysate (obtained using 15-kDa cut-off dialysis membrane) from donor rabbits subjected to rIPC similarly protected against cardiac infarction. However, the protective substances containing in rIPC plasma have been unknown. In the present study, we showed that rIPC plasma exerted anti-apoptotic and anti-oxidative effects on human neural stem cells under oxygen glucose deprivation (OGD) that mimics brain ischemia. Additionally, we applied the sample to the liquid chromatography integrated with mass spectrometry to identify candidate key molecules in the rIPC plasma and determine its role in protecting neural stem cells from OGD-induced cell death. Thioredoxin increased significantly after rIPC compared to pre-IPC. Pretreatment with thioredoxin, the antioxidant protein, markedly protected human neural stem cells from OGD-induced cell death. The effect of thioredoxin on brain ischemia in animals should be further evaluated. However, the present study first evaluated the effect of rIPC in the ischemic cellular model.

Sex differences of dental pathology in early modern samurai and commoners at Kokura in Japan.

So-called "Ohaguro", teeth blackening, in the married females was a general custom regardless of class in the early modern period. As a result, Ohaguro was thought to have enhanced the acid resistance of tooth substance and tightened gingiva and prevented tooth morbidity due to periodontal disease. For investigation into the influence of Ohaguro, the skeletal remains of early modern samurai and commoners at Kokura were examined for differences in the dental pathology based on sex. Though females from archeological sites have significantly more carious teeth and antemortem tooth loss (AMTL) than males in the previous studies, the prevalence of caries and AMTL in males was higher than in females among the early modern samurai and commoners in Kokura. The efficacies of Ohaguro may influence the good dental health of females. On the other hand, as females were considered inferior to males under the feudal system in Japan, males, including children, might tend to consume more nutritious foods compared to females. However, those foods are certainly not better with regard to dental health, since those foods are more highly cariogenic. These factors may have caused higher caries and AMTL prevalence among males compared to females in early modern Kokura.

An immuno-wall microdevice exhibits rapid and sensitive detection of IDH1-R132H mutation specific to grade II and III gliomas.

World Health Organization grade II and III gliomas most frequently occur in the central nervous system (CNS) in adults. Gliomas are not circumscribed; tumor edges are irregular and consist of tumor cells, normal brain tissue, and hyperplastic reactive glial cells. Therefore, the tumors are not fully resectable, resulting in recurrence, malignant progression, and eventual death. Approximately 69-80% of grade II and III gliomas harbor mutations in the isocitrate dehydrogenase 1 gene (IDH1), of which 83-90% are found to be the IDH1-R132H mutation. Detection of the IDH1-R132H mutation should help in the differential diagnosis of grade II and III gliomas from other types of CNS tumors and help determine the boundary between the tumor and normal brain tissue. In this study, we established a highly sensitive antibody-based device, referred to as the immuno-wall, to detect the IDH1-R132H mutation in gliomas. The immuno-wall causes an immunoreaction in microchannels fabricated using a photo-polymerizing polymer. This microdevice enables the analysis of the IDH1 status with a small sample within 15 min with substantially high sensitivity. Our results suggested that 10% content of the IDH1-R132H mutation in a sample of 0.33 µl volume, with 500 ng protein, or from 500 cells is theoretically sufficient for the analysis. The immuno-wall device will enable the rapid and highly sensitive detection of the IDH1-R132H mutation in routine clinical practice.

Transvertebral anterior cervical foraminotomy: midterm outcomes of clinical and radiological assessments including the finite element method.

PURPOSE: The aim of this study was to compare the clinical features, radiological changes, biomechanical effects, and efficacy in patients treated by transvertebral anterior foraminotomy. Preservation of segmental motion and avoidance of adjacent segment degeneration are theoretical advantages of transvertebral anterior foraminotomy. In practice, this procedure is minimally invasive and has shown good clinical results, especially in patients with unilateral cervical radiculopathy. METHOD: We conducted a retrospective minimum 2-year follow-up study of the cervical spine of patients treated by transvertebral anterior foraminotomy at our institution. Radiological outcomes, which were estimated by measuring disc and functional spinal unit heights, and the angle and range of motion (ROM) from C2 to C7 of the functional spinal unit and adjacent segments were evaluated. Furthermore, a three-dimensional finite element method was used to biomechanically analyze the strength of the postoperative vertebral body. RESULTS: Between 2004 and 2009, 34 patients underwent surgery. The improvement rate was 94.2 %. The average flexion-extension ROM from C2 to C7 was 36.6 ± 16.6°. On plain radiographs, the disc height and ROM and height of the functional spinal unit in the operated segment were not significantly decreased relative to the preoperative levels. The finite element method also revealed that there was no difference in strength between the pre- and postvertebral bodies. CONCLUSIONS: These results demonstrate that biomechanical stability was achieved. Transvertebral anterior cervical foraminotomy did not limit motion in the operated and adjacent segments and did not cause a significant decrease in disc and vertebral heights after surgery.

Comparative Study of Surgical Outcomes of Occipitocervical and Atlantoaxial Fusion for Retro-Odontoid Pseudotumor.

OBJECTIVE: To compare the surgical and radiographic outcomes of occipitocervical fusion (OCF) with those of atlantoaxial fusion (AAF) in patients with cervical myelopathy caused by retroodontoid pseudotumors (ROPs). METHODS: This retrospective, comparative study included 26 patients; 12 underwent occipitocervical fusion (OCF) (group O) and 14 retroodontoid pseudotumor (AAF) (group A) with a minimum 2-year follow-up. Neurologic outcomes were evaluated using the Japanese Orthopedic Association (JOA) score. Radiologic assessment included the maximum anteroposterior (AP) diameter of the anteroposterior-retroodontoid pseudotumor (AP-ROP), C2-7 angle, O-C2 angle, C1-2 angle, atlantodental interval (ADI), range of motion (ROM) of the ADI, C2-C7 sagittal vertical axis (C2-7 SVA), and T1 slope. Global spinal alignments (pelvic incidence [PI] minus lumbar lordosis [LL] [PI-LL], pelvic tilt, sacral slope, and C7 sagittal vertical axis) were also compared between the groups. RESULTS: Both groups had equally good clinical outcomes with equal complication rates. Three patients had a three-level fusion, 5 cases had a four-level fusion, and 4 cases had more than five-level fusion in group O. All cases had a single-level fusion in group A. Surgical time was significantly shorter in group A. AP-ROP was significantly downsized postoperatively in both groups and was more prominent in group O. C2-7 SVA was significantly increased and C2-7A ROM was significantly reduced in group O at the final follow-up. The PI-LL showed a significant increase in group O at the final follow-up. CONCLUSIONS: Although OCF and AAF were similarly effective for cervical myelopathy with ROP, AAF was less invasive, and spinal alignment was better maintained postoperatively in AAF than OCF.

Surgical Outcomes of Common Peroneal Nerve Entrapment Neuropathy Associated with L5 Radiculopathy.

Impingement of the common peroneal nerve, a branch of the L5 nerve root, causes common peroneal nerve entrapment neuropathy (CPNE). Although there are cases of CPNE associated with L5 radiculopathy, surgical intervention's effectiveness remains to be elucidated. This retrospective case-control study aimed to evaluate the efficacy of surgery in patients with CPNE associated with L5 radiculopathy. Twenty-two patients (25 limbs) with surgically treated CPNE between 2015 and 2022 were retrospectively reviewed. The limbs were classified into two groups: group R (limbs of CPNE associated with L5 radiculopathy) and group O (limbs of CPNE without L5 radiculopathy). The durations from onset to surgery, the nerve conduction studies (NCSs), and postoperative improvement rates for motor weakness, pain, and dysesthesia were compared between the groups. Group R included 15 limbs (13 patients), and group O included 10 limbs (9 patients). There were no significant differences in the duration from onset to surgery or abnormal findings of NCS between the two groups. The postoperative improvement rates were 88% and 100% (p = 0.62) for muscle weakness, 87% and 80% (p = 0.53) for pain, and 71% and 56% (p = 0.37) for dysesthesia in group R and group O, respectively, without significant differences between groups. CPNE associated with L5 radiculopathy is common, and the results of the present study showed that the surgical outcomes in such cases were satisfactory and comparable to those in CPNE without L5 radiculopathy.

Comparative Study of Anterior Transvertebral Foraminotomy and Anterior Cervical Discectomy and Fusion for Unilateral Cervical Spondylotic Radiculopathy.

OBJECTIVE: To study the compared surgical and radiographic outcomes of Transvertebral foraminotomy (TVF) with anterior cervical discectomy and fusion (ACDF) in patients with unilateral cervical spondylotic radiculopathy (CSR). METHODS: We performed a retrospective comparative study of 72 consecutive patients with 1- or 2-level CSR treated with ACDF or TVF. 27 patients who underwent TVF (group T) and 45 patients who underwent ACDF (group A) with a minimum 2-year follow-up were enrolled. We evaluated clinical outcomes and radiological assessment. Clinical outcome included Visual analog scale (VAS) scores for axial, arm pain at preoperatively and final follow-up. VAS score for painful swallowing was also evaluated 1 week after surgery. Radiological assessment included C2-7 sagittal Cobb angle (C2-7 CA), range of motion (ROM) of C2-7 CA, the height, angle and ROM of the functional spinal unit (FSU), and tip of the spinous process of the operated segment. We also evaluated the disc height, FSU angle, and ROM of the FSU at the cranial adjacent segment. RESULTS: Both groups had good clinical outcomes. Soft tissue swelling was significantly less prominent in group T than that for group A. VAS scores for painful swallowing is lower in group T without significant difference. The ROM of C2-7 CA, FSU, and spinous processes demonstrated a significant reduction in group A compared with group T.(P < 0.05). Disc height at the cranial adjacent segment was maintained in group T. CONCLUSIONS: TVF is as effective as ACDF for unilateral CSR and preserves whole cervical spine and segmental alignment.

Evaluation of Posterior Ligamentous Complex Injury in Thoracolumbar Burst Fractures: Correlation Analysis of CT and MRI Findings.

The goal of this study is to perform correlation analysis of Computed tomography (CT) and magnetic resonance imaging (MRI) results in posterior ligament complex (PLC) injury and define the morphological traits of thoracolumbar (TL) burst fractures connected to PLC injury. Forty patients with surgically repaired TL burst fractures between January 2013 and December 2020 were retrospectively analyzed. The patients were split into two groups for comparison based on MRI (Group P: patients with a confirmed or suspected PLC injury; Group N: patients with PLC injury denied). The radiographic morphological examination based on CT scans and clinical evaluation was performed and compared between two groups. The thoracolumbar injury classification and severity score (TLICS), the load sharing classification (LSC) scores, and the number of patients with neurological impairments were considerably greater in Group P. Loss of height of the fracture (loss height), local kyphosis of the fracture (local kyphosis), and supraspinous distance were significantly higher in Group P and significantly associated with PLC injuries indicating severe vertebral body destruction and traumatic kyphosis in multivariate logistic analysis [odds ratio: 1.90, 1.06, and 1.13, respectively]. Cutoff value for local kyphosis obtained from the receiver operating characteristic curve was 18.8. If local kyphosis is greater than 18.8 degrees on CT scans, we should take into account the probability of the highly damaged burst fracture associated with PLC injury. In this situation, we should carefully assess MRI to identify the spinal cord injury or spinal cord compression in addition to PLC injury because these instances likely present with neurological abnormalities.

Laminectomy triggers symptomatic growth of spinal schwannoma in a patient with schwannomatosis.

Background: Schwannomatosis (SWN) is genetically similar to neurofibromatosis type 2 (NF2) and represents a NF2 gene mutation. Previous studies have shown that these mutations in both neurons and Schwann cells can lead to the development of schwannomas after nerve crush injuries. Here, we reviewed the potential pathoanatomical mechanisms for the development of a trauma-induced spinal schwannomas in a 55-year-old male with SWN. Case Description: A 49-year-old male had originally undergone a L3-L5 lumbar laminectomy for stenosis; the schwannomas seen on the preoperative magnetic resonance imaging (MRI) were not resected. Now at age 55, he newly presented with low back pain and numbness in the left L5 dermatome, and he was diagnosed with an L4 vertebral level cauda equina tumor on MRI. Following gross-total resection, the histopathological assessment revealed a Ki-67 labeling index 5-10% in hotspots (i.e., slightly higher than the normal range of schwannomas) and a 20% mosaic loss of SMARCB1. Based on these criteria, he was diagnosed as having SWN. Conclusion: In this patient with SWN, compression/physical trauma to nerves of the cauda equina during the L3-L5 laminectomy 6 years ago likely caused the progression of schwannoma.

Downward penetrating endplate screw technique under O-arm navigation posterior fusion in patients with osteoporotic vertebral body fractures associated with diffuse idiopathic skeletal hyperostosis.

Background: A downward penetrating endplate screw (PES) technique combined with caudal anchor screws inserted in the upward direction under O-arm navigation (i.e., crossing screw technique) avoided screw backout and proximal junctional kyphosis (PJK) in three patients with osteoporotic vertebral body fractures and diffuse idiopathic skeletal hyperostosis (DISH). Methods: The PES techniques were utilized for patients with T12 (one patient) and L1 (two patients) spontaneous fusion across the targeted vertebrae, with minimal damage to the involved endplates/intervertebral discs. The average number of instrumented vertebrae was 5.3. Results: There were no perioperative complications over the mean follow-up period of 28.7 months; no screw loosening, and no PJK. Conclusion: The PES technique prevented screw backout, and PJK in three patients with lumbar osteoporotic vertebral fractures and DISH.

Radiological Analysis of Minimally Invasive Microscopic Laminectomy for Lumbar Canal Stenosis with a Focus on Multilevel Stenosis and Spondylolisthesis.

OBJECTIVE: We retrospectively compared the radiological and clinical outcomes of two different surgical techniques (lumbar spinous process splitting laminectomy [LSPSL] and unilateral laminotomy for bilateral decompression [ULBD]) to treat lumbar spinal canal stenosis (LCS). METHODS: We performed a retrospective comparative study of 141 consecutive patients with an average age of 70.8 ± 9.4 years who had undergone LSPSL or ULBD for LCS between April 2015 and April 2019. None of the patients had developed remote fractures of the spinous processes using either technique. These cases were divided into 2 groups: group L, 73 patients who had undergone LSPSL from April 2015 to April 2017; and group U, 68 patients who had undergone ULBD from May 2017 to April 2019. The clinical and radiological outcomes and surgical complications at the 1-year postoperative follow-up period were evaluated. RESULTS: We found no significant differences in the operative time between the 2 groups. However, group U had had significantly less blood loss than group L. The facet joints were significantly well preserved in group U. We examined the multilevel and spondylolisthesis cases separately and found that both surgical procedures were equally effective and that the visual analog scale scores for back or leg pain and Japanese Orthopaedic Association scores had significantly improved postoperatively in each group. Group U showed better outcomes in terms of LCS recurrence, with 3 patients in the group L requiring repeat surgery. CONCLUSIONS: We found both ULBD and LSPSL to be safe and effective techniques for LCS, even for patients with spondylolisthesis and multilevel disease. ULBD was superior in terms of recurrence prevention, preservation of the facet joints, and less blood loss.

Spinal Cord Stimulation for Neuropathic Pain following a Spinal Cord Lesion with Past Spinal Surgical Histories Using a Paddle Lead Placed on the Rostral Side of the Lesion: Report of Three Cases.

Spinal cord parenchymal lesions may induce intractable neuropathic pain. However, the efficacy of conventional spinal cord stimulation for the neuropathic pain following spinal cord lesions remains to be controversial. In this study, we present three cases of spinal cord stimulation using a paddle lead at the rostral side of the spinal lesion causing pain symptoms. Good pain reductions were achieved using conventional stimulation in one case and using differential target multiplexed stimulation in two cases. Case 1: A 55-year-old man presented with neuropathic pain affecting his bilateral upper extremities due to a traumatic cervical spinal cord injury. Conventional stimulation via a paddle-type electrode was able to reduce the pain from 8 to 4 via a visual analog scale. Case 2: A 67-year-old man had undergone three spinal surgeries. He presented with pain and numbness of bilateral lower extremities due to a spinal cord lesion by thoracic disc herniation. Differential target multiplexed stimulation via a paddle-type electrode achieved excellent pain reduction, that is, from 9 to 2 on the visual analog scale. Case 3: An 80-year-old man presented with pain in his bilateral upper extremities due to a cervical spinal cord lesion caused by compression and spinal canal stenosis. Posterior cervical decompression and paddle-type electrode placement were performed simultaneously. Differential target multiplexed stimulation was able to achieve excellent pain reduction, from 7 to 2 on the visual analog scale. Spinal cord stimulation using a paddle lead at the rostral side of the spinal lesion and differential target multiplexed stimulation may provide significant opportunities for patients with intractable neuropathic pain following spinal cord lesions.

Safety and Validity of Anterior Cervical Disc Replacement for Single-level Cervical Disc Disease: Initial Two-year Follow-up of the Prospective Observational Post-marketing Surveillance Study for Japanese Patients.

Anterior cervical disc replacement (ACDR) using cervical artificial disc (CAD) has the advantage of maintaining the range of motion (ROM) at the surgical level, subsequently reducing the postoperative risk of adjacent disc disease. Following the approval for the clinical use in Japan, a post-marketing surveillance (PMS) study was conducted for two different types of CAD, namely, Mobi-C (metal-on-plastic design) and Prestige LP (metal-on-metal design). The objective of this prospective observational multicenter study was to analyze the first 2-year surgical results of the PMS study of 1-level ACDR in Japan. A total of 54 patients were registered (Mobi-C, n = 24, MC group; Prestige LP, n = 30, PLP group). Preoperative neurological assessment revealed radiculopathy in 31 patients (57.4%) and myelopathy in 15 patients (27.8%). Preoperative radiological assessment classified the disease category as disc herniation in 15 patients (27.8%), osteophyte in 6 patients (11.1%), and both in 33 patients (61.1%). The postoperative follow-up rates at 6 weeks, 6 months, 1 year, and 2 years after ACDR were 92.6%, 87.0%, 83.3%, and 79.6%, respectively. In both groups, patients' neurological condition improved significantly after surgery. Radiographic assessment revealed loss of mobility at the surgical level in 9.5% of patients in the MC group and in 9.1% of patients in the PLP group. No secondary surgeries at the initial surgical level and no serious adverse events were observed in either group. The present results suggest that 1-level ACDR is safe, although medium- to long-term follow-up is mandatory to further verify the validity of ACDR for Japanese patients.

Double Crush Syndrome of the Lower Limb in L5 Radiculopathy and Peroneal Neuropathy: A Case Report.

Double crush syndrome (DCS) is a clinical condition involving impingement of the spinal and peripheral nerves. DCS of the lower limbs has been recognized; however, no detailed reports have been published. Herein, we report a rare case of the coexistence of L5 radiculopathy and peroneal nerve entrapment neuropathy. The patient suffered from pain in the left lower leg and left foot combined with muscle weakness in the left leg without a Tinel-like sign in the peroneal tunnel area. MRI showed a deficit in the left L5 nerve root sleeve, and X-ray imaging revealed L5 spondylolysis. Lumbar fusion surgery was performed at L5-S1. Subsequently, the patient's symptoms were partially improved, but the pain and toe and ankle motor weakness persisted. In addition, a Tinel-like sign appeared at the entrapment point of the peroneal nerve. The entrapped peroneal nerve was decompressed, and the patient's symptoms improved. The patient had L5 radiculopathy owing to the improvement in his symptoms in the upper leg before and after lumbar surgery. It is unclear why no Tinel-like sign was detected before the first surgery, but we hypothesized that L5 nerve disorder may mask the symptoms triggered by compression of the peroneal nerve due to the complex pathology of DCS and dynamic factors. Distinguishing between radiculopathy and relative peripheral neuropathy should always be a consideration. DCS may mask characteristic symptoms, and it is important to carefully follow up the patient to detect changes in his or her condition.

Clinical Safety Assessment of Autologous Freeze-Drying Platelet-Rich Plasma for Bone Regeneration in Maxillary Sinus Floor Augmentation: A Pilot Study.

The purpose of this clinical study is to evaluate the safety and preliminary efficacy of autologous freeze-drying platelet-rich plasma (FD-PRP) on bone regeneration in maxillary sinus floor augmentation as a preliminary pilot study. Five patients that required sinus floor augmentation to facilitate the placement of dental implants participated in this clinical study. The PRP was prepared from the autologous peripheral blood and was lyophilized and stored at -20 °C for 4 weeks before surgery. At surgery, triple-concentrated FD-PRP (x3FD-PRP) mixed with synthetic bone grafting materials was rehydrated following the transplantation into the sinus floor. The primary outcome was a safety verification of x3FD-PRP, evaluated in terms of the clinical course and consecutive blood tests. The secondary outcome was clinical efficacy focused on bone regeneration in sinus floor augmentation evaluated by radiographic examination and implant stability. There were no adverse events, such as systemic complications, excessive inflammatory reactions, severe infection, or local site healing complications, besides those on the usual course associated with surgery. Vertical augmented height was maintained, and the initial stability of implants was achieved post-operatively in 6 months. The results obtained in this study suggest that x3FD-PRP can be used safely for bone engineering in clinical practice. Further studies are required to draw a conclusion concerning the efficacy of x3FD-PRP since this was a pilot study with a single arm and a small sample size.