The use of polylactic and polyglycolic copolymer biomaterial in a pre-clinical model of compromised primary stability

Aim Primary implant stability can be compromised by overdrilling of the implant bed. Filling the gap between the implant and the bone with a highly viscous copolymer of polylactic and polyglycolic acid (PLA/PGA) might stabilize the implant and thus supply osseointegration. The aim of this study was to evaluate implants installed in overdrilled beds associated with PLA/PGA in rats tibia model by means of removal torque test and fluorochrome analysis. Materials and methods For this experiment two groups were selected: in the test group 0.4 mm overdrilled defects (2.0 in diameter and 3 mm long ) were produced in the right tibia of seven rats and implants were placed covered with PLA/PGA biomaterial to fill the gap; the control group was not overdrilled and the implants were placed without the biomaterial. Implants of 1.6 mm in diameter and 3 mm long where placed into all defects. Calcein, alizarin and oxytetracyclin were injected at 7, 15 and 21 postoperative days, respectively, and the animals were sacrificed at 35 postoperative day. Results The results showed that all the implants achieved osseointegration. There were no statistical significance differences in torque-reverse and fluorocrome analysis (P>0.05). Conclusion We can conclude that overdrilled defects filled with PLA/PGA did not disturb osseointegration in this experimental model. © ARIESDUE.

Analysis of primary stability of dental implants inserted in different substrates using the pullout test and insertion torque

The aim of the study was to evaluate mechanical behavior of implants inserted in three substrates, by measuring the pullout strength and the relative stiffness. 32 implants (Master Porous-Conexao, cylindrical, external hexagon, and surface treatment) were divided into 4 groups (n = 8): pig rib bone, polyurethane Synbone, polyurethane Nacional 40 PCF, and pinus wood. Implants were installed with the exact distance of 5 mm of another implant. The insertion torque (N·cm) was quantified using the digital Kratos torque meter and the pullout test (N) was performed by an axial traction force toward the long axis of the implant (2 min/mm) through mount implant devices attached to a piece adapted to a load cell of 200 Kg of a universal testing machine (Emic DL10000). Data of insertion torque and maximum pullout force were submitted to one-way ANOVA and Bonferroni tests (α = 0.05). Polyurethane Nacional 40 PCF and pinus wood showed the highest values of insertion torque and pullout force, with significant statistical difference (P < 0.05) with other groups. The analysis showed stiffness materials with the highest values for primary stability. © 2013 Nathalia Ferraz Oliscovicz et al.

Osseointegration of anodized implant: effect of fibrin adhesive/TEA on primary stability

Processo FAPESP: 2012/24545-3

Biocompatibility of experimental Ti-30Ta implants with compromised primary stability: effect of TEA

Purpose: Ti-Ta alloys have high potential for dental application due to a good balance between high strength and low modulus. Absence of primary anchoring may occur when dental implants are installed immediately after tooth extraction. Tranexamic acid (TEA) is used to reduce fibrin degradation and can prevent early blood clot breakdown. The aim of this study was to evaluate the biocompatibility of Ti-30Ta implants associated or not with tranexamic acid and installed with compromised primary stability. Methods and materials: Fabricated were 20 implants of titanium ASTM F67 (Grade 4) and 20 implants of Ti-30Ta alloy with dimensions of 2.1 mm × 2.8 mm Ø. They were divided (n = 10) into Group I (Ti machined), Group II (Ti machined/tranexamic acid), Group III (Ti-30Ta alloy) and Group IV (Ti-30Ta/tranexamic acid) and were implanted in tibia (defects with 2.5 mm × 3.2 mm Ø) of 40 male rats (250 g). The surgical sites were rinsed with 5% tranexamic acid solution in Groups II and IV. The animals were euthanized at 45 days postoperative. The pieces were processed in methyl methacrylate (Stevenel's blue/Alizarin red). The percentage of peri-implant tissue repair was analyzed via images obtained by an optical microscope coupled to a digital camera using Leica software and Adobe Photoshop QWin. Data were analyzed statistically with a significance level of 5%. Results: Histomorphometric results showed 97.16% of bone-implant contact for group IV, 89.78% of bone contact for group III, 70.89% for group II and 61.59% of bone contact for group I. The statistical analyses demonstrated significant differences (P < 0.05) among group I and other groups. Conclusion: The results suggest that (a) Ti-30Ta promoted an increase of bone healing and apposition around implant; (b) tranexamic acid favored the stabilization of blood clot and bone formation.

In vitro analysis of the influence of surface treatment of dental implants on primary stability

Surface treatment interferes with the primary stability of dental implants because it promotes a chemical and micromorphological change on the surface and thus stimulates osseointegration. This study aimed to evaluate the effects of different surface treatments on primary stability by analyzing insertion torque (IT) and pullout force (PF). Eight samples of implants with different surface treatments (TS - external hexagon with acid surface treatment; and MS - external hexagon, machined surface), all 3.75 mm in diameter x 11.5 mm in length, were inserted into segments of artificial bones. The IT of each sample was measured by an electronic torquemeter, and then the pullout test was done with a universal testing machine. The results were subjected to ANOVA (p < 0.05), followed by Tukey's test (p < 0.05). The IT results showed no statistically significant difference, since the sizes of the implants used were very similar, and the bone used was not highly resistant. The PF values (N) were, respectively, TS = 403.75 +/- 189.80 and MS = 276.38 +/- 110.05. The implants were shown to be different in terms of the variables of maximum force (F = 4.401, p = 0.0120), elasticity in maximum flexion (F = 3.672, p = 0.024), and relative stiffness (F = 4.60, p = 0.01). In this study, external hexagonal implants with acid surface treatment showed the highest values of pullout strength and better stability, which provide greater indication for their use.

Primary stability in cementless total hip replacement: measurement techniques and aided-surgery

Primary stability of stems in cementless total hip replacements is recognized to play a critical role for long-term survival and thus for the success of the overall surgical procedure. In Literature, several studies addressed this important issue. Different approaches have been explored aiming to evaluate the extent of stability achieved during surgery. Some of these are in-vitro protocols while other tools are coinceived for the post-operative assessment of prosthesis migration relative to the host bone. In vitro protocols reported in the literature are not exportable to the operating room. Anyway most of them show a good overall accuracy. The RSA, EBRA and the radiographic analysis are currently used to check the healing process of the implanted femur at different follow-ups, evaluating implant migration, occurance of bone resorption or osteolysis at the interface. These methods are important for follow up and clinical study but do not assist the surgeon during implantation. At the time I started my Ph.D Study in Bioengineering, only one study had been undertaken to measure stability intra-operatively. No follow-up was presented to describe further results obtained with that device. In this scenario, it was believed that an instrument that could measure intra-operatively the stability achieved by an implanted stem would consistently improve the rate of success. This instrument should be accurate and should give to the surgeon during implantation a quick answer concerning the stability of the implanted stem. With this aim, an intra-operative device was designed, developed and validated. The device is meant to help the surgeon to decide how much to press-fit the implant. It is essentially made of a torsional load cell, able to measure the extent of torque applied by the surgeon to test primary stability, an angular sensor that measure the relative angular displacement between stem and femur, a rigid connector that enable connecting the device to the stem, and all the electronics for signals conditioning. The device was successfully validated in-vitro, showing a good overall accuracy in discriminating stable from unstable implants. Repeatability tests showed that the device was reliable. A calibration procedure was then performed in order to convert the angular readout into a linear displacement measurement, which is an information clinically relevant and simple to read in real-time by the surgeon. The second study reported in my thesis, concerns the evaluation of the possibility to have predictive information regarding the primary stability of a cementless stem, by measuring the micromotion of the last rasp used by the surgeon to prepare the femoral canal. This information would be really useful to the surgeon, who could check prior to the implantation process if the planned stem size can achieve a sufficient degree of primary stability, under optimal press fitting conditions. An intra-operative tool was developed to this aim. It was derived from a previously validated device, which was adapted for the specific purpose. The device is able to measure the relative micromotion between the femur and the rasp, when a torsional load is applied. An in-vitro protocol was developed and validated on both composite and cadaveric specimens. High correlation was observed between one of the parameters extracted form the acquisitions made on the rasp and the stability of the corresponding stem, when optimally press-fitted by the surgeon. After tuning in-vitro the protocol as in a closed loop, verification was made on two hip patients, confirming the results obtained in-vitro and highlighting the independence of the rasp indicator from the bone quality, anatomy and preserving conditions of the tested specimens, and from the sharpening of the rasp blades. The third study is related to an approach that have been recently explored in the orthopaedic community, but that was already in use in other scientific fields. It is based on the vibration analysis technique. This method has been successfully used to investigate the mechanical properties of the bone and its application to evaluate the extent of fixation of dental implants has been explored, even if its validity in this field is still under discussion. Several studies have been published recently on the stability assessment of hip implants by vibration analysis. The aim of the reported study was to develop and validate a prototype device based on the vibration analysis technique to measure intra-operatively the extent of implant stability. The expected advantages of a vibration-based device are easier clinical use, smaller dimensions and minor overall cost with respect to other devices based on direct micromotion measurement. The prototype developed consists of a piezoelectric exciter connected to the stem and an accelerometer attached to the femur. Preliminary tests were performed on four composite femurs implanted with a conventional stem. The results showed that the input signal was repeatable and the output could be recorded accurately. The fourth study concerns the application of the device based on the vibration analysis technique to several cases, considering both composite and cadaveric specimens. Different degrees of bone quality were tested, as well as different femur anatomies and several levels of press-fitting were considered. The aim of the study was to verify if it is possible to discriminate between stable and quasi-stable implants, because this is the most challenging detection for the surgeon in the operation room. Moreover, it was possible to validate the measurement protocol by comparing the results of the acquisitions made with the vibration-based tool to two reference measurements made by means of a validated technique, and a validated device. The results highlighted that the most sensitive parameter to stability is the shift in resonance frequency of the stem-bone system, showing high correlation with residual micromotion on all the tested specimens. Thus, it seems possible to discriminate between many levels of stability, from the grossly loosened implant, through the quasi-stable implants, to the definitely stable one. Finally, an additional study was performed on a different type of hip prosthesis, which has recently gained great interest thus becoming fairly popular in some countries in the last few years: the hip resurfacing prosthesis. The study was motivated by the following rationale: although bone-prosthesis micromotion is known to influence the stability of total hip replacement, its effect on the outcome of resurfacing implants has not been investigated in-vitro yet, but only clinically. Thus the work was aimed at verifying if it was possible to apply to the resurfacing prosthesis one of the intraoperative devices just validated for the measurement of the micromotion in the resurfacing implants. To do that, a preliminary study was performed in order to evaluate the extent of migration and the typical elastic movement for an epiphyseal prosthesis. An in-vitro procedure was developed to measure micromotions of resurfacing implants. This included a set of in-vitro loading scenarios that covers the range of directions covered by hip resultant forces in the most typical motor-tasks. The applicability of the protocol was assessed on two different commercial designs and on different head sizes. The repeatability and reproducibility were excellent (comparable to the best previously published protocols for standard cemented hip stems). Results showed that the procedure is accurate enough to detect micromotions of the order of few microns. The protocol proposed was thus completely validated. The results of the study demonstrated that the application of an intra-operative device to the resurfacing implants is not necessary, as the typical micromovement associated to this type of prosthesis could be considered negligible and thus not critical for the stabilization process. Concluding, four intra-operative tools have been developed and fully validated during these three years of research activity. The use in the clinical setting was tested for one of the devices, which could be used right now by the surgeon to evaluate the degree of stability achieved through the press-fitting procedure. The tool adapted to be used on the rasp was a good predictor of the stability of the stem. Thus it could be useful for the surgeon while checking if the pre-operative planning was correct. The device based on the vibration technique showed great accuracy, small dimensions, and thus has a great potential to become an instrument appreciated by the surgeon. It still need a clinical evaluation, and must be industrialized as well. The in-vitro tool worked very well, and can be applied for assessing resurfacing implants pre-clinically.

Significance of primary stability for osseointegration of dental implants

AIM: To investigate the significance of the initial stability of dental implants for the establishment of osseointegration in an experimental capsule model for bone augmentation. MATERIAL AND METHODS: Sixteen male rats were used in the study. In each rat, muscle-periosteal flaps were elevated on the lateral aspect of the mandibular ramus on both sides, resulting in exposure of the bone surface. Small perforations were then produced in the ramus. A rigid, hemispherical Teflon capsule with a diameter of 6 mm and a height of 4 mm and with a hole in its middle portion, prepared to fit the circumference of an ITI HC titanium implant of 2.8 mm in diameter, was fixed to the ramus using 4 mini-screws. On one side of the jaw, the implant was placed through the hole in such a way that its apex did not make contact with the mandibular ramus (test). This placement of the implant did not ensure primary stability. On the other side of the jaw, a similar implant was placed through the hole of the capsule in such a way that contact was made between the implant and the surface of the ramus (control). This provided primary stability of the implant. After placement of the implants, the soft tissues were repositioned over the capsules and sutured. After 1, 3, 6 and 9 months, four animals were sacrificed and subjected to histometric analysis. RESULTS: The mean height of direct bone-to-implant contact of implants with primary stability was 38.8%, 52.9%, 64.6% and 81.3% of the implant length at 1, 3, 6 and 9 months, respectively. Of the bone adjacent to the implant surface, 28.1%, 28.9%, 52.6% and 69.6%, respectively, consisted of mineralized bone. At the test implants, no bone-to-implant contact was observed at any observation time or in any of these non-stabilized specimens. CONCLUSION: The findings of the present study indicate that primary implant stability is a prerequisite for successful osseointegration, and that implant instability results in fibrous encapsulation, thus confirming previously made clinical observations.

Three-dimensional primary stability of cementless femoral stems

OBJECTIVE: This study investigates by means of a new bone-prosthesis interface motion detector whether conceptual design differences of femoral stems are reflected in their primary stability pattern. DESIGN: An in vitro experiment using a biaxial materials testing machine in combination with three-dimensional motion measurement devices was performed. BACKGROUND: Primary stability of uncemented total hip replacements is considered to be a prerequisite for the quality of bony ongrowth to the femoral stem. Dynamic motion as a response to loading as well as total motion of the prosthesis have to be considered under quasi-physiological cyclic loading conditions. METHODS: Seven paired fresh cadaveric femora were used for the testing of two types of uncemented femoral stems with different anchoring concepts: CLS stem (Spotorno) and Cone Prosthesis (Wagner). Under sinusoidal cyclic loading mimicking in vivo hip joint forces a new measurement technique was applied allowing for the analysis of the three-dimensional interface motion. RESULTS: Considerable differences between the two prostheses could be detected both in their dynamic motion and total motion behaviour. Whereas the CLS stem, due to the wedge-shaped concept, provides smaller total motions, the longitudinal ribs of the Cone prostheses result in a substantially smaller dynamic motion. CONCLUSIONS: The measuring technique provided reliable and accurate data illustrating the three-dimensional interface motion of uncemented femoral stems.

Compromised Primary Implant Stability

The aim of this study was to evaluate implants installed with compromised primary stability associated or not with polylactide and polyglycolide copolymer (PLA/PGA). Two 0.4-mm overdrilled defects (3 mm in diameter and 6 mm long) were produced in the right tibia of 25 rabbits. Half of the defects were left untreated, and the other half was filled with PLA/PGA. Implants of 2.6 mm in diameter and 6 mm long were placed into all defects. Animals were killed at 5, 15, 40, and 60 postoperative days, and biomechanical analysis (torque-reverse), histomorphometry, and immunohistochemistry (osteoprotegerin, receptor activator of NFJB ligand [RANKL], osteocalcin, and collagen-1 [ COL- I] staining) were performed. All the implants achieved osseointegration. There were no statistically significant differences in the torque-reverse and in linear contact extension between bone tissue and implant surface and no statistically significant difference in osteoprotegerin, RANKL, osteocalcin, and collagen-1 expression between the studied groups in all studied periods (P > 0.05). We can conclude that osseointegration can occur in compromised primary implant stability situations, and the addition of PLA/PGA did not improve the osseointegration process in this experimental model.

Stability of dental implants after irradiation with an 830-nm low-level laser: a double-blind randomized clinical study

Little is known about the benefits of low-level laser therapy (LLLT) on improvement of stability of dental implants. The aim of this randomized clinical study was to assess the LLLT effect on implants stability by means of resonance frequency analysis (RFA). Thirty implants were distributed bilaterally in the posterior mandible of eight patients. At the experimental side, the implants were submitted to LLLT (830 nm, 86 mW, 92.1 J/cm(2), 0.25 J, 3 s/point, at 20 points), and on the control side, the irradiation was simulated (placebo). The first irradiation was performed in the immediate postoperative period, and it was repeated every 48 h in the first 14 days. The initial implant stability quotient (ISQ) of the implants was measured by means of RFA. New ISQ measurements were made after 10 days, 3, 6, 9, and 12 weeks. The initial ISQ values ranged from 65-84, with a mean of 76, undergoing a significant drop in stability from the 10th day to the 6th week in the irradiated group, and presenting a gradual increase from the 6th to the 12th week. The highest ISQ values were observed on the 10th day in the irradiated group, and the lowest in the 6th week in both groups. Under the conditions of this study, no evidence was found of any effect of LLLT on the stability of the implants when measured by RFA. Since high primary stability and good bone quality are of major relevancy for a rigid bone-implant interface, additional LLLT may have little impact macroscopically.

Implant Stability Measurements of Two Immediate Loading Protocols for the Edentulous Mandible: Rigid and Semi-rigid Splinting of the Implants

Aim: Primary and secondary stabilities of immediately loaded mandibular implants restored with fixed prostheses (FP) using rigid or semirigid splinting systems were clinically and radiographically evaluated. Methods: Fifteen edentulous patients were rehabilitated using hybrid FP; each had 5 implants placed between the mental foramens. Two groups were randomly divided: group 1-FP with the conventional rigid bar splinting the implants and group 2-semi-rigid cantilever extension system with titanium bars placed in the 2 distal abutment cylinders. Primary stability was evaluated using resonance frequency analysis after installation of the implant abutments. The measurements were made at 3 times: T0, at baseline; T1, 4 months after implant placement; and T2, 8 months after implant placement. Presence of mobility and inflammation in the implant surrounding regions were checked. Stability data were submitted to statistical analysis for comparison between groups (P, 0.05). Results: Implant survival rate for the implants was of 100% in both groups. No significant differences in the mean implant stability quotient values were found for both groups from baseline and after the 8-month follow-up. Conclusion: The immediate loading of the implants was satisfactory, and both splinting conditions (rigid and semi-rigid) can be successfully used for the restoration of edentulous mandibles. (Implant Dent 2012;21:486-490)

SOFT TISSUE INTEGRATION IN THE NECK AREA OF TITANIUM IMPLANTS - AN ANIMAL TRIAL

Dental implant materials are required to enable good apposition of bone and soft tissues. They must show sufficient resistance to chemical, physical and biological stress in the oral cavity to achieve good long-term outcomes. A critical issue is the apposition of the soft tissues, as they have provided a quasi-physiological closure of oral cavity. The present experiment was performed to study the peri-implant tissue response to non-submerged (1-stage) implant installation procedures. Two different implants types (NobelBiocare, NobelReplace (R) Tapered Groovy 4.3 x 10 mm and Replace (R) Select Tapered TiU RP 4.3 x 10 mm) were inserted into the right and left sides of 8 domestic pigs (Sus scrofa domestica) mandibles, between canines and premolars and immediately provided with a ceramic crown. Primary implant stability was determined using ressonance frequency analysis. Soft tissue parameters were assessed: sulcus depth (SDI) and junctional epithelium (JE). Following 70 days of healing, jaw sections were processed for histology and histomorphometric examination. Undecalcified histological sections demonstrated osseointegration with direct bone contact. The soft tissue parameters revealed no significant differences between the two implant types. The peri-implant soft tissues appear to behave similarly in both implant types.

A new technique to measure micromotion distribution around a cementless femoral stem.

The interfacial micromotion is closely associated to the long-term success of cementless hip prostheses. Various techniques have been proposed to measure them, but only a few number of points over the stem surface can be measured simultaneously. In this paper, we propose a new technique based on micro-Computer Tomography (μCT) to measure locally the relative interfacial micromotions between the metallic stem and the surrounding femoral bone. Tantalum beads were stuck at the stem surface and spread at the endosteal surface. Relative micromotions between the stem and the endosteal bone surfaces were measured at different loading amplitudes. The estimated error was 10μm and the maximal micromotion was 60μm, in the loading direction, at 1400N. This pilot study provided a local measurement of the micromotions in the 3 direction and at 8 locations on the stem surface simultaneously. This technique could be easily extended to higher loads and a much larger number of points, covering the entire stem surface and providing a quasi-continuous distribution of the 3D interfacial micromotions around the stem. The new measurement method would be very useful to compare the induced micromotions of different stem designs and to optimize the primary stability of cementless total hip arthroplasty.

Tightening force and torque of nonlocking screws in a reverse shoulder prosthesis.

BACKGROUND: Reversed shoulder arthroplasty is an accepted treatment for glenohumeral arthritis associated to rotator cuff deficiency. For most reversed shoulder prostheses, the baseplate of the glenoid component is uncemented and its primary stability is provided by a central peg and peripheral screws. Because of the importance of the primary stability for a good osteo-integration of the baseplate, the optimal fixation of the screws is crucial. In particular, the amplitude of the tightening force of the nonlocking screws is clearly associated to this stability. Since this force is unknown, it is currently not accounted for in experimental or numerical analyses. Thus, the primary goal of this work is to measure this tightening force experimentally. In addition, the tightening torque was also measured, to estimate an optimal surgical value. METHODS: An experimental setup with an instrumented baseplate was developed to measure simultaneously the tightening force, tightening torque and screwing angle, of the nonlocking screws of the Aquealis reversed prosthesis. In addition, the amount of bone volume around each screw was measured with a micro-CT. Measurements were performed on 6 human cadaveric scapulae. FINDINGS: A statistically correlated relationship (p<0.05, R=0.83) was obtained between the maximal tightening force and the bone volume. The relationship between the tightening torque and the bone volume was not statistically significant. INTERPRETATION: The experimental relationship presented in this paper can be used in numerical analyses to improve the baseplate fixation in the glenoid bone.