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Osseodensification drilling vs conventional manual instrumentation technique for posterior lumbar fixation: Ex-vivo mechanical and histomorphological analysis in an ovine model
Torroni, Andrea; Lima Parente, Paulo Eduardo; Witek, Lukasz; Hacquebord, Jacques Henri; Coelho, Paulo G
Lumbar fusion is a procedure associated with several indications, but screw failure remains a major complication, with an incidence ranging 10% to 50%. Several solutions have been proposed, ranging from more efficient screw geometry to enhance bone quality, conversely, drilling instrumentation have not been thoroughly explored. The conventional instrumentation (regular [R]) techniques render the bony spicules excavated impractical, while additive techniques (osseodensification [OD]) compact them against the osteotomy walls and predispose them as nucleating surfaces/sites for new bone. This work presents a case-controlled split model for in vivo/ex vivo comparison of R vs OD osteotomy instrumentation in posterior lumbar fixation in an ovine model to determine feasibility and potential advantages of the OD drilling technique in terms of mechanical and histomorphology outcomes. Eight pedicle screws measuring 4.5 mm × 45 mm were installed in each lumbar spine of eight adult sheep (four per side). The left side underwent R instrumentation, while the right underwent OD drilling. The animals were killed at 6- and 12-week and the vertebrae removed. Pullout strength and non-decalcified histologic analysis were performed. Significant mechanical stability differences were observed between OD and R groups at 6- (387 N vs 292 N) and 12-week (312 N vs 212 N) time points. Morphometric analysis did not detect significant differences in bone area fraction occupancy between R and OD groups, while it is to note that OD showed increased presence of bone spiculae. Mechanical pullout testing demonstrated that OD drilling provided higher degrees of implant anchoring as a function of time, whereas a significant reduction was observed for the R group.
PMID: 32369220
ISSN: 1554-527x
CID: 4439042
Osseodensification effect on implants primary and secondary stability: Multicenter controlled clinical trial
Bergamo, Edmara T P; Zahoui, Abbas; Barrera, Raúl Bravo; Huwais, Salah; Coelho, Paulo G; Karateew, Edward Dwayne; Bonfante, Estevam A
BACKGROUND:Osseodensification (OD) has shown to improve implant stability; however, the influences of implant design, dimensions, and surgical site characteristics are unknown. PURPOSE/OBJECTIVE:To compare the insertion torque (IT) and temporal implant stability quotients (ISQ) of implants placed via OD or subtractive drilling (SD). MATERIALS AND METHODS/METHODS:This multicenter controlled clinical trial enrolled 56 patients, whom were in need of at least 2 implants (n = 150 implants). Patients were treated with narrow, regular, or wide implants and short, regular, or long implants in the anterior or posterior region of the maxilla or in the posterior region of the mandible. Osteotomies were performed following manufacturers recommendation. IT was recorded with a torque indicator. ISQ was recorded with resonance frequency analysis immediately after surgery, 3 and 6 weeks. RESULTS:Data complied as a function of osteotomy indicated significantly higher IT for OD relative to SD. OD outperformed conventional SD for all pairwise comparisons of arches (maxilla and mandible) and areas operated (anterior and posterior), diameters and lengths of the implants, except for short implants. Overall, ISQ data also demonstrated significantly higher values for OD compared to SD regardless of the healing period. Relative to immediate readings, ISQ values significantly decreased at 3 weeks, returning to immediate levels at 6 weeks; however, ISQ values strictly remained above 68 throughout healing time for OD. Data as a function of arch operated and osteotomy, area operated and osteotomy, implant dimensions and osteotomy, also exhibited higher ISQ values for OD relative to SD on pairwise comparisons, except for short implants. CONCLUSIONS:OD demonstrated higher IT and temporal ISQ values relative to SD, irrespective of arch and area operated as well as implant design and dimension, with an exception for short implants. Future studies should focus on biomechanical parameters and bone level change evaluation after loading.
PMID: 34047046
ISSN: 1708-8208
CID: 4895002
Three-Dimensionally-Printed Bioactive Ceramic Scaffolds: Construct Effects on Bone Regeneration
Fama, Christopher; Kaye, Gabriel J; Flores, Roberto; Lopez, Christopher D; Bekisz, Jonathan M; Torroni, Andrea; Tovar, Nick; Coelho, Paulo G; Witek, Lukasz
BACKGROUND/PURPOSE/OBJECTIVE:The utilization of three-dimensionally (3D)-printed bioceramic scaffolds composed of beta-tricalcium phosphate in conjunction with dipyridamole have shown to be effective in the osteogenesis of critical bone defects in both skeletally immature and mature animals. Furthermore, previous studies have proven the dura and pericranium's osteogenic capacity in the presence of 3D-printed scaffolds; however, the effect galea aponeurotica on osteogenesis in the presence of 3D scaffolds remains unclear. METHOD/DESCRIPTION/UNASSIGNED:Critical-sized (11 mm) bilateral calvarial defects were created in 35-day old rabbits (n = 7). Two different 3D scaffolds were created, with one side of the calvaria being treated with a solid nonporous cap and the other with a fully porous cap. The solid cap feature was designed with the intention of preventing communication of the galea and the ossification site, while the porous cap permitted such communication. The rabbits were euthanized 8 weeks postoperatively. Calvaria were analyzed using microcomputed tomography, 3D reconstruction, and nondecalcified histologic sectioning in order assess differences in bone growth between the two types of scaffolding. RESULTS:Scaffolds with the solid (nonporous) cap yielded greater percent bone volume (P = 0.012) as well as a greater percent potential bone (P = 0.001) compared with the scaffolds with a porous cap. The scaffolds with porous caps also exhibited a greater percent volume of soft tissue (P < 0.001) presence. There were no statistically significant differences detected in scaffold volume. CONCLUSION/CONCLUSIONS:A physical barrier preventing the interaction of the galea aponeurotica with the scaffold leads to significantly increased calvarial bone regeneration in comparison with the scaffolds allowing for this interaction. The galea's interaction also leads to more soft tissue growth hindering the in growth of bone in the porous-cap scaffolds.
PMID: 33003153
ISSN: 1536-3732
CID: 5050092
Survival of implant-supported resin-matrix ceramic crowns: In silico and fatigue analyses
Bergamo, Edmara T P; Yamaguchi, Satoshi; Coelho, Paulo G; Lopes, Adolfo C O; Lee, Chunwoo; Bonfante, Gerson; Benalcázar Jalkh, Ernesto B; de Araujo-Júnior, Everardo N S; Bonfante, Estevam A
OBJECTIVE:To evaluate the fatigue survival, failure mode, and maximum principal stress (MP Stress) and strain (MP Strain) of resin-matrix ceramic systems used for implant-supported crowns. METHODS:Identical molar crowns were milled using four resin-matrix ceramics (n = 21/material): (i) Shofu Hard, (ii) Cerasmart (iii) Enamic, and (iv) Shofu HC. Crowns were cemented on the abutments, and the assembly underwent step-stress accelerated-life testing. Use level probability Weibull curves at 300 N were plotted and the reliability at 300, 500 and 800 N was calculated for a mission of 50,000 cycles. Fractographic analysis was performed using stereomicroscope and scanning electron microscope. MP Stress and MP Strain were determined by finite element analysis. RESULTS:While fatigue dictated failures for Cerasmart (β > 1), material strength controlled Shofu Hard, Enamic, and Shofu HC failures (β < 1). Shofu HC presented lower reliability at 300 N (79%) and 500 N (59%) than other systems (>90%), statistically different at 500 N. Enamic (57%) exhibited a significant reduction in the probability of survival at 800 N, significantly lower than Shofu Hard and Cerasmart; however, higher than Shofu HC (12%). Shofu Hard and Cerasmart (>93%) demonstrated no significant difference for any calculated mission (300-800 N). Failure mode predominantly involved resin-matrix ceramic fracture originated from occlusal cracks, corroborating with the MP Stress and Strain location, propagating through the proximal and cervical margins. SIGNIFICANCE/CONCLUSIONS:All resin-matrix ceramics crowns demonstrated high probability of survival in a physiological molar load, whereas Shofu Hard and Cerasmart outperformed Enamic and Shofu HC at higher loads. Material fracture comprised the main failure mode.
PMID: 33483102
ISSN: 1879-0097
CID: 4819212
Effect of Surgical Instrumentation Variables on the Osseointegration of Narrow- and Wide-Diameter Short Implants
Witek, Lukasz; Parra, Marcelo; Tovar, Nick; Alifarag, Adham; Lopez, Christopher D; Torroni, Andrea; Bonfante, Estevam A; Coelho, Paulo G
PURPOSE/OBJECTIVE:The aim of the present study was to systematically analyze how a multifactorial surgical instrumentation approach affects osseointegration on both narrow-diameter and wide-diameter short implants. MATERIALS AND METHODS/METHODS:Twelve skeletally mature female sheep were used in the study along with 144 plateau-root-form healing chamber titanium (Ti-6Al-4V) implants (Bicon LLC, Boston, MA), evenly distributed between narrow (3.5 mm) and wide (6.0 mm) diameters. The presence or the absence of irrigation, different drilling speeds, and 2 time points quantifying bone-implant contact (BIC) and bone area fraction occupancy (BAFO) to evaluate the osteogenic parameters around the implants. RESULTS:There were no signs of inflammation, infection, or failure of the implants observed at either healing period. The narrow 3.5-mm implant, at 6 weeks, yielded significant differences in terms of BIC at a drilling speed of 50 rotations per minute (RPM), with higher values of the samples using irrigation (30.6 ± 6.1%) compared with those without (19.7 ± 6.1%). No statistical differences were detected for 500 and 1,000 RPM with or without irrigation. The wide 6-mm diameter implant showed differences with respect to drilling speed, 500 and 1,000 RPM, with higher values associated with samples subjected to irrigation. BAFO results, for both diameters, only detected statistical differences between the 2 times (3 vs 6 weeks); no statistical differences were detected when evaluating as a function of time, drilling speed, and irrigation. CONCLUSIONS:Surgical instrumentation variables (ie, drilling speed [RPM] and irrigation) yielded to be more of an effect for BIC at longer healing time (6 weeks) for the wider implants. Furthermore, deploying narrow or wide plateau-root-form implants, where conditions allow, has shown to be a safe alternative, considering the high BIC and BAFO values observed, independent of irrigation.
PMID: 33137302
ISSN: 1531-5053
CID: 4759432
Comparison of Surface Treatments of Endosteal Implants in Ovariectomized Rabbits
Parra, Marcelo; Elias, Carlos Nelson; Olate, Sergio; Witek, Lukasz; Coelho, Paulo G
PURPOSE/OBJECTIVE:The aim of this work was to evaluate osseointegration of endosteal implants with two different surface treatments at early stages (~3 weeks) in the tibia of healthy and ovariectomized rabbits. MATERIALS AND METHODS/METHODS:The study comprised 10 adult New Zealand female rabbits (Oryctolagus cuniculus; 6 months and 3.0 ± 0.5 kg). Five animals were subjected to bilateral ovariectomy to mimic osteoporotic-like conditions, and the remaining rabbits (n = 5) served as the healthy control group. After 3 months, specimens from the ovariectomized and control groups were subject to implant placement in both tibiae, using two different types of surface treatment. A total of 36 implants were placed, n = 18 acid-etched and n = 18 anodized. After 3 weeks, euthanasia of the animals was performed, and samples were obtained for processing. Bone-to-implant contact and bone area fraction occupancy were quantified to evaluate the osseointegration parameters around the implant surface and within the thread area, respectively, and nanoindentation tests were performed to determine elastic modulus and hardness of the new bone. Both analyses were performed on the entire implant (total), as well as individually within the cortical and bone marrow cavity area. RESULTS:All animals were evaluated with no signs of infection or postoperative complications. The total bone-to-implant contact and bone area fraction occupancy results, independent of surface treatment, yielded significant differences between the ovariectomized and control groups (P = .002 and P < .001, respectively). In the marrow cavity, analyzing the surface treatments independently as a function of bone condition, the only differences detected were in the anodized treatment (P = .04). Regarding the elastic modulus, differences were detected only with the anodized implants between the ovariectomized and control groups (P = .015). CONCLUSION/CONCLUSIONS:At 3 weeks after implant placement, there were better osseointegration values of the implants in the healthy control group compared with the ovariectomized group independent of surface treatment. Also, specifically in the medullary region of the rabbit tibia, the acid-etched implants had more uniform osseointegration values in conditions of low-quality bone in comparison to the anodized implants, histomorphometrically and biomechanically.
PMID: 33600521
ISSN: 1942-4434
CID: 4821002
Clinical application of a FOXO1 inhibitor improves connective tissue healing in a diabetic minipig model
Jeon, Hyeran H; Yu, Quan; Witek, Lukasz; Lu, Yongjian; Zhang, Tianshou; Stepanchenko, Olga; Son, Victoria J; Spencer, Evelyn; Oshilaja, Temitope; Shin, Min K; Alawi, Faizan; Coelho, Paulo G; Graves, Dana T
The forkhead box O1 (FOXO1) transcription factor plays a key role in wound healing process. Recently it has been reported that lineage-specific genetic ablation of FOXO1 significantly improves diabetic wound healing in a mouse model. To investigate the clinical usefulness of these findings, translational preclinical studies with a large animal model are needed. We report for the first time that the local application of a FOXO1 inhibitor (AS1842856) significantly improves connective tissue healing in a preclinical T2DM minipig model, reflected by increased collagen matrix formation, increased myofibroblast numbers, improved angiogenesis, and a shift in cell populations from pro-inflammatory (IL-1β+, TNF-α+ and iNOS+) to pro-healing (CD163+). Our results set up the basis for the clinical application of a FOXO1 antagonist in early diabetic wounds where there is impaired connective tissue healing.
PMCID:7868841
PMID: 33594326
ISSN: 1943-8141
CID: 4820992
Retention of zirconia crowns to Ti-base abutments: effect of luting protocol, abutment treatment and autoclave sterilization
Bergamo, Edmara T. P.; Zahoui, Abbas; Amorin Ikejiri, Larissa Luri; Marun, Manoela; da Silva, Kimberly Peixoto; Coelho, Paulo G.; Soares, Simone; Bonfante, Estevam A.
ISI:000668171300007
ISSN: 1883-1958
CID: 5017242
Histological and Nanomechanical Properties of a New Nanometric Hydroxiapatite Implant Surface. An In Vivo Study in Diabetic Rats
Oliveira, Paula G F P; Coelho, Paulo G; Bergamo, Edmara T P; Witek, Lukasz; Borges, Cristine A; Bezerra, Fábio B; Novaes, Arthur B; Souza, Sergio L S
Implant therapy is a predictable treatment to replace missing teeth. However, the osseointegration process may be negatively influenced by systemic conditions, such as diabetes mellitus (DM). Microtopography and implant surface developments are strategies associated to better bone repair. This study aimed to evaluate, in healthy and diabetic rats, histomorphometric (bone to implant contact = %BIC; and bone area fraction occupancy = %BAFO) and nanomechanical (elastic modulus = EM; and hardness = H) bone parameters, in response to a nanometric hydroxyapatite implant surface. Mini implants (machined = MAC; double acid etched = DAE, and with addition of nano-hydroxyapatite = NANO) were installed in tibias of healthy and diabetic rats. The animals were euthanized at 7 and 30 days. NANO surface presented higher %BIC and %BAFO when compared to MAC and DAE (data evaluated as a function of implant surface). NANO surface presented higher %BIC and %BAFO, with statistically significant differences (data as a function of time and implant surface). NANO surface depicted higher EM and H values, when compared to machined and DAE surfaces (data as a function of time and implant surface). Nano-hydroxyapatite coated implants presented promising biomechanical results and could be an important tool to compensate impaired bone healing reported in diabetics.
PMID: 33322243
ISSN: 1996-1944
CID: 4726652
Three-Dimensional Printing for Craniofacial Bone Tissue Engineering
Shen, Chen; Witek, Lukasz; Flores, Roberto L; Tovar, Nick; Torroni, Andrea; Coelho, Paulo G; Kasper, F Kurtis; Wong, Mark; Young, Simon
The basic concepts from the fields of biology and engineering are integrated into tissue engineering to develop constructs for the repair of damaged and/or absent tissues, respectively. The field has grown substantially over the past two decades, with particular interest in bone tissue engineering (BTE). Clinically, there are circumstances in which the quantity of bone that is necessary to restore form and function either exceeds the patient's healing capacity or bone's intrinsic regenerative capabilities. Vascularized osseous or osteocutaneous free flaps are the standard of care with autologous bone remaining the gold standard, but is commonly associated with donor site morbidity, graft resorption, increased operating time, and cost. Regardless of the size of a craniofacial defect, from trauma, pathology, and osteonecrosis, surgeons and engineers involved with reconstruction need to consider the complex three-dimensional (3D) geometry of the defect and its relationship to local structures. Three-dimensional printing has garnered significant attention and presents opportunities to use craniofacial BTE as a technology that offers a personalized approach to bony reconstruction. Clinicians and engineers are able to work together to produce patient-specific space-maintaining scaffolds tailored to site-specific defects, which are osteogenic, osseoconductive, osseoinductive, encourage angiogenesis/vasculogenesis, and mechanically stable upon implantation to prevent immediate failure. In this work, we review biological and engineering principles important in applying 3D printing technology to BTE for craniofacial reconstruction as well as present recent translational advancements in 3D printed bioactive ceramic scaffold technology.
PMCID:7759279
PMID: 32842918
ISSN: 1937-335x
CID: 4751522