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1.
Biomater Adv ; 161: 213900, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38772132

ABSTRACT

This study investigates the safety and efficacy of 3D-printed polycaprolactone/hydroxyapatite (PCL/HA) scaffolds for patient-specific cranioplasty surgeries, employing liquid deposition modeling (LDM) technology. This research is pioneering as it explores the impact of gamma radiation on PCL/HA scaffolds and utilizes printing ink with the highest content of HA known in the composite. The mechanical, morphological, and macromolecular stability of the gamma-sterilized scaffolds were verified before implantation. Subsequent research involving animal subjects was conducted to explore the effects of sterilized implants. Eventually, three clinical cases were selected for the implantation studies as part of a phase 1 non-randomized open-label clinical trial. It was shown that a 25 kGy gamma-ray dose for sterilizing the printed implants did not alter the required geometrical precision of the printed implants. The implants exhibited well-distributed HA and strength comparable to cancellous bone. Gamma radiation reduced hydrophobicity and water uptake capacity without inducing pyrogenic or inflammatory responses. Personalized PCL/HA substitutes successfully treated various craniomaxillofacial defects, including trauma-induced facial asymmetry and congenital deformities. HA nanoparticles in the ink stimulated significant osteoconductive responses within three months of implantation. Moreover, the results revealed that while larger implants may exhibit a slower bone formation response in comparison to smaller implants, they generally had an acceptable rate and volume of bone formation. This clinical trial suggests the application of a sterilized PCL/HA composite for craniomaxillofacial surgery is safe and could be considered as a substitute for autologous bone.


Subject(s)
Durapatite , Gamma Rays , Polyesters , Printing, Three-Dimensional , Durapatite/chemistry , Durapatite/therapeutic use , Humans , Polyesters/chemistry , Animals , Sterilization/methods , Male , Female , Tissue Scaffolds/chemistry , Prostheses and Implants , Adult , Bone Substitutes/chemistry , Bone Substitutes/therapeutic use
2.
Am J Sports Med ; 52(7): 1826-1833, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38767159

ABSTRACT

BACKGROUND: Multilayered osteochondral scaffolds are becoming increasingly utilized for the repair of knee joint surface lesions (KJSLs). However, the literature on predictive factors is rather limited. PURPOSE: To (1) evaluate the clinical outcomes and safety of a combined single-step approach using a biomimetic collagen-hydroxyapatite scaffold (CHAS) and filtered bone marrow aspirate (fBMA) for the treatment of KJSLs and (2) identify significant predictors of the treatment outcomes. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: All patients who underwent surgery because of a KJSL (size ≥1.5 cm2; International Cartilage Regeneration & Joint Preservation Society grades 3-4) using the combination above were selected from a hospital registry database (100 patients; minimum 2-year follow-up). Patient characteristics, medical history, knee joint and lesion status, intraoperative details, and cellular parameters of the injected fBMA were collected. The arthroscopic evaluation of chondral and meniscal tissue quality in all knee compartments was performed using the Chondropenia Severity Score. Treatment outcomes were determined clinically using patient-reported outcome measures (Knee Injury and Osteoarthritis Outcome Score, EuroQol-5 Dimensions-3 Levels, EuroQol-Visual Analog Scale, and Tegner Activity Scale) and by assessing the occurrence of serious adverse events and graft failure. Multivariable regression analysis was performed to identify significant predictors of the treatment outcomes. RESULTS: At a mean follow-up of 54.2 ± 19.4 months, 78 (87%) patients completed the questionnaires with significant improvements toward the baseline (P < .00625): KOOS Pain subscale from 62 ± 17 to 79 ± 18, KOOS Total score from 57 ± 16 to 70 ± 20, EuroQol-Visual Analog Scale from 61 ± 21 to 76 ± 16, EuroQol-5 Dimensions-3 Levels from 0.57 ± 0.20 to 0.80 ± 0.21, and Tegner Activity Scale from 2.8 ± 1.5 to 3.9 ± 1.9. The graft failure rate was 4%. A longer duration of preoperative symptoms, previous surgery, larger lesions, older age, and female sex were the main negative predictors for the treatment outcomes. The Chondropenia Severity Score and the number of fibroblast colony-forming units in fBMA positively influenced some of the clinical results and safety. CONCLUSION: A CHAS augmented with fBMA proved to be an adequate and safe approach for the treatment of KJSLs up to midterm follow-up. Based on the subanalysis of predictive factors, the surgical intervention should be performed in a timely and precise manner to prevent lesion enlargement, deterioration of the general knee cartilage status, and recurrent surgical procedures, especially in older and female patients. When a CHAS is used, the quantity of MSCs seems to play a role in augmentation. REGISTRATION: NCT06078072 (ClinicalTrials.gov identifier).


Subject(s)
Cartilage, Articular , Tissue Scaffolds , Adolescent , Adult , Female , Humans , Male , Middle Aged , Young Adult , Arthroscopy/methods , Bone Marrow Transplantation/methods , Cartilage, Articular/surgery , Collagen/therapeutic use , Durapatite/therapeutic use , Knee Injuries/surgery , Knee Joint/surgery , Patient Reported Outcome Measures , Treatment Outcome
3.
J Craniomaxillofac Surg ; 52(4): 420-431, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38461138

ABSTRACT

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.


Subject(s)
Dental Implants , Plastic Surgery Procedures , Humans , Durapatite/therapeutic use , Tomography, X-Ray Computed , Orbit
4.
J Plast Reconstr Aesthet Surg ; 92: 118-129, 2024 May.
Article in English | MEDLINE | ID: mdl-38518624

ABSTRACT

INTRODUCTION: Facial aging has long been an area of focus in esthetic surgery. It is the consequence of physiologic and environmental factors, with a trend toward non-surgical modalities. Although volume augmentation has long been a focus of non-surgical facial rejuvenation, there is emerging interest in the use of biostimulators to induce physiologic changes in the skin. This article aimed to provide an overview of this class of therapies. METHODS: A systematic review regarding the clinical use of biostimulatory agents including platelet-rich plasma (PRP), platelet-rich fibrin (PRF), poly-L-lactic acid (PLLA) and calcium hydroxylapatite (CaHA) in facial rejuvenation was performed using PubMed databases. The protocol was developed following the preferred reporting for items for systematic reviews-protocols guidelines. Included studies matched predetermined criteria according to the employed intervention and outcomes. RESULTS: The systematic review was performed in September 2023, with the primary search yielding 464 articles. Abstract review resulted in 73 articles of potential relevance. Comprehensive review of the articles and manual reference checks were performed, independently, by 2 authors. This yielded a total of 45 articles that met the inclusion criteria. CONCLUSIONS: There is an increasing role for non-surgical modalities in facial rejuvenation. Biostimulatory agents may be used as an alternative, or act as an adjunct, to other non-surgical modalities. These agents induce physiologic changes that mitigate facial aging. There is limited, quantifiable data, which fully illustrate the effect in these products. Although these agents are known to illicit inflammatory changes, more controlled studies are needed to better elucidate the biostimulatory capacity of such non-surgical treatments.


Subject(s)
Cosmetic Techniques , Rejuvenation , Skin Aging , Humans , Skin Aging/drug effects , Face , Polyesters , Durapatite/therapeutic use , Platelet-Rich Plasma
5.
J Dent ; 145: 104973, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38556192

ABSTRACT

OBJECTIVE: Assessed the effect of dental products containing nano-hydroxyapatite (nano-HA) + fluoride on the remineralization of white spot lesions (WSL) in vivo or in situ. METHODS: Seven databases were explored using a two-pronged approach (intervention/treatment). After screening, full-text assessment, and further exclusion, the qualitative synthesis of five studies (four clinical and one in situ) was performed. Based on the Cochrane collaboration guidelines relevant data of the studies were collected and summarized. The Cochrane risk of bias tool for randomized trials (RoB 2.0) was used to appraise the studies' methodological quality and the GRADE guidelines to assess their level of evidence. The RoB 2.0 domains were rated on their risk of bias (RoB) as low, high, or with some concerns, and an adaptation of the tool was used to the in situ study. RESULTS: The included studies assessed 151 WSL in anterior permanent teeth, on patients with varying ages. The protocol application, treatment length (7d-12 w), and control groups varied greatly between the studies making the performance of a quantitative analysis unfeasible. The general RoB of the clinical studies was classified as being of low risk (n = 2) or some concerns (n = 2). The in situ study was considered as being of low risk. The level of the evidence was moderate. Most of the studies found moderate evidence regarding the superiority of this association in clinical settings. CONCLUSION: Even with the nano-HA + fluoride promising results for the remineralization treatment of WSL, due to the restricted number of studies and types of products, its extended use cannot be recommended based on the current systematic review, especially when considering the moderate level of the evidence found. CLINICAL SIGNIFICANCE: Due to the biocompatibility and higher surface coverage of nano-HA and the remineralization capacity of fluoride formulations, the association of these elements to remineralize WSL has been positively reported. After the collection and qualitative appraise of the data, the clinical evidence of the use of these dental products is promising but limited.


Subject(s)
Cariostatic Agents , Dental Caries , Dental Enamel , Durapatite , Fluorides , Tooth Remineralization , Humans , Tooth Remineralization/methods , Durapatite/therapeutic use , Fluorides/therapeutic use , Dental Enamel/drug effects , Dental Caries/drug therapy , Cariostatic Agents/therapeutic use
6.
Quintessence Int ; 55(4): 328-334, 2024 Apr 25.
Article in English | MEDLINE | ID: mdl-38329717

ABSTRACT

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.


Subject(s)
Bone Regeneration , Bone Substitutes , Calcium Sulfate , Durapatite , Minerals , Random Allocation , Rats, Wistar , Skull , Animals , Bone Substitutes/therapeutic use , Bone Substitutes/pharmacology , Rats , Bone Regeneration/drug effects , Skull/surgery , Calcium Sulfate/therapeutic use , Calcium Sulfate/pharmacology , Durapatite/therapeutic use , Minerals/therapeutic use , Cattle , Piezosurgery/methods , Male , Biocompatible Materials/therapeutic use , Bone Matrix/transplantation , Osteogenesis/drug effects , Alveolar Process/pathology
7.
World Neurosurg ; 184: e367-e373, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38307197

ABSTRACT

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.


Subject(s)
Spinal Diseases , Spinal Fusion , Humans , Titanium , Spinal Fusion/methods , Sacroiliac Joint/surgery , Prospective Studies , Durapatite/therapeutic use , Minimally Invasive Surgical Procedures/methods , Spinal Diseases/surgery , Outcome Assessment, Health Care
8.
J Prosthet Dent ; 131(4): 742.e1-742.e8, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38383281

ABSTRACT

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.


Subject(s)
Alloys , Titanium , Titanium/therapeutic use , Titanium/chemistry , Staphylococcus aureus , Durapatite/therapeutic use , Wettability , Surface Properties , Microscopy, Electron, Scanning
9.
Eur J Orthop Surg Traumatol ; 34(3): 1535-1541, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38267791

ABSTRACT

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.


Subject(s)
Arthroplasty, Replacement, Hip , Femoral Fractures , Femoral Neck Fractures , Hip Prosthesis , Periprosthetic Fractures , Humans , Osseointegration , Durapatite/therapeutic use , Retrospective Studies , Femoral Neck Fractures/surgery , Arthroplasty, Replacement, Hip/adverse effects , Prosthesis Design , Femoral Fractures/surgery , Periprosthetic Fractures/surgery
10.
Clin Implant Dent Relat Res ; 26(1): 183-196, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37789642

ABSTRACT

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.


Subject(s)
Bone Substitutes , Durapatite , Animals , Cattle , Dogs , Biocompatible Materials/therapeutic use , Bone Regeneration , Bone Substitutes/therapeutic use , Durapatite/therapeutic use , Mandible/surgery , Minerals , Osteogenesis
11.
Clin Oral Implants Res ; 35(2): 155-166, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37987199

ABSTRACT

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.


Subject(s)
Bone Substitutes , Sinus Floor Augmentation , Humans , Durapatite/therapeutic use , Sinus Floor Augmentation/methods , Prospective Studies , Quality of Life , Hydroxyapatites/therapeutic use , Bone Substitutes/therapeutic use , Maxillary Sinus/surgery
12.
Medicina (Kaunas) ; 59(11)2023 Nov 09.
Article in English | MEDLINE | ID: mdl-38004027

ABSTRACT

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.


Subject(s)
Durapatite , Tooth Socket , Humans , Biocompatible Materials/therapeutic use , Bone Regeneration , Durapatite/therapeutic use , Multicenter Studies as Topic , Tooth Socket/surgery
13.
Med Sci Monit ; 29: e941112, 2023 Oct 24.
Article in English | MEDLINE | ID: mdl-37872747

ABSTRACT

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.


Subject(s)
Bone Substitutes , Fractures, Bone , Humans , Retrospective Studies , Bone Substitutes/therapeutic use , Bone Substitutes/chemistry , Case-Control Studies , Fractures, Bone/drug therapy , Fractures, Bone/surgery , Durapatite/therapeutic use , Durapatite/chemistry , Fracture Healing , Treatment Outcome
14.
BMC Oral Health ; 23(1): 826, 2023 10 30.
Article in English | MEDLINE | ID: mdl-37904192

ABSTRACT

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.


Subject(s)
Lasers, Solid-State , Nanoparticles , Humans , Lasers, Solid-State/therapeutic use , Durapatite/pharmacology , Durapatite/therapeutic use , Dental Enamel , Hardness , Nanoparticles/therapeutic use
15.
Int J Oral Maxillofac Implants ; 38(5): 923-932, 2023 Oct 17.
Article in English | MEDLINE | ID: mdl-37847834

ABSTRACT

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.


Subject(s)
Alveolar Ridge Augmentation , Bone Substitutes , Dogs , Animals , Cattle , Durapatite/therapeutic use , Osteogenesis , X-Ray Microtomography , Guided Tissue Regeneration, Periodontal/methods , Bone Regeneration/physiology , Bone Substitutes/therapeutic use , Collagen/therapeutic use , Alveolar Ridge Augmentation/methods
16.
Br J Oral Maxillofac Surg ; 61(9): 587-597, 2023 11.
Article in English | MEDLINE | ID: mdl-37845099

ABSTRACT

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.


Subject(s)
Bone Regeneration , Tissue Scaffolds , Humans , Tissue Engineering/methods , Polyesters , Durapatite/therapeutic use
17.
BMC Oral Health ; 23(1): 695, 2023 09 27.
Article in English | MEDLINE | ID: mdl-37759198

ABSTRACT

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.


Subject(s)
Dentin Sensitivity , Powders , Humans , Dentin Sensitivity/therapy , Durapatite/therapeutic use , Japan , Pain , Powders/therapeutic use
18.
J Contemp Dent Pract ; 24(7): 500-506, 2023 Jul 01.
Article in English | MEDLINE | ID: mdl-37622630

ABSTRACT

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.


Subject(s)
Bone and Bones , Durapatite , Platelet-Rich Fibrin , Humans , Biocompatible Materials/therapeutic use , Calcium Phosphates/therapeutic use , Durapatite/therapeutic use , Bone and Bones/drug effects , Bone and Bones/surgery
19.
Clin Implant Dent Relat Res ; 25(5): 974-983, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37288709

ABSTRACT

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.


Subject(s)
Dental Implants , Sinus Floor Augmentation , Humans , Sinus Floor Augmentation/methods , Dental Implantation, Endosseous/methods , Pilot Projects , Prospective Studies , Durapatite/therapeutic use , Maxillary Sinus/surgery , Maxilla/surgery
20.
J Dent ; 135: 104601, 2023 08.
Article in English | MEDLINE | ID: mdl-37364728

ABSTRACT

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.


Subject(s)
Dental Caries , Tooth Demineralization , Humans , Dental Caries/diagnostic imaging , Dental Caries/drug therapy , Dental Caries Susceptibility , Porosity , Tooth Demineralization/diagnostic imaging , Tooth Demineralization/pathology , Durapatite/therapeutic use
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