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Studi ini bertujuan untuk mengembangkan produk implant tulang belakang mono-aksial pedicle screw. Prototipe implan yang terdiri dari beberapa variasi desain geometri telah didesain dan difabrikasi menggunakan metode machining. Variasi prototipe terdiri dari 3 ukuran depth thread yang berbeda, 3 ukuran pitch yang berbeda, dan 2 variasi conical. Setelah dilakukan evaluasi geometri 2 dari 7 variasi prototipe implan pedicle screw tidak sesuai dengan bentuk desainnya, dan untuk 5 variasi lainnya memiliki penyimpangan <5% dari ukuran dimensi desain. Prototipe tersebut diuji dengan pengujian pull out, torsi, dan bending untuk mengetahui performanya. Hasil pengujian pull out tertinggi dihasilkan oleh variasi pitch dengan ukuran pitch 2,1 mm dengan nilai 1658, 25 N.  Untuk nilai pull out tertinggi pada variasi depth thread dimiliki oleh ukuran depth thread 0,9 mm dengan nilai 1563,5 N. Sedangkan untuk nilai torsi terendah dihasilkan oleh variasi pitch pada ukuran 2,1 mm sebesar 0,15 Nm, dan untuk untuk variasi depth thread pada ukuran 0,9 mm sebesar 0,59 Nm. Untuk pengujian bending dilakukan pada 1 variasi pedicle screw dengan beban nilai terbesar 707 N. Setelah dilakukan beberapa pengujian pada ke-7 variasi didapatkan bahwa faktor geometri desain pedicle screw dapat mempengaruhi secara signifikan maupun tidak signifikan.

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The aim of this study is to develop a mono-axial pedicle screw for spinal implants. The implant prototype, which had varied geometries and designs, was produced through machining. The variation in the prototypes consisted of 3 different thread depths, 3 different pitch lengths, and 2 different conical geometries. After evaluations were made on the prototypes, 2 of the 7 variant prototypes did not match its original design geometry and dimensions. Meanwhile, the other 5 prototypes had a <5% measurement deviation compared to its original design. The prototypes were all tested for its pull out, torsion, and bending capabilities to compare their performances. The highest measurement in the pull out test, in terms of pitch, was made by the prototype with the 2.1 mm pitch which resulted in a 1658.25 N measurement. In terms of the thread depth, the highest measurement in the pull out test was made by the prototype with the 0.9 mm thread depth which resulted in a 1563.5 N measurement. For the torsion test, in terms of pitch, the least torsion was made by the prototype with the 2.1 mm pitch resulting in a 1.5 Nm in torsion. As for the thread depth, the least torsion was done by the prototype with the 0.9 mm thread depth at 0.59 Nm in torsion. For the bending test, the highest load obtained was 707 N in one variation of the pedicle screw. Based on the results of the tests, it can be summarized that the geometric design of the pedicle screw may affect its perfomance significantly.

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"Instrumentasi posterior mengharuskan dipertahankannya fiksasi stabil sekrup pedikel di tulang belakang untuk mencapai fusi. Hal ini dapat menjadi sulit terutama pada kondisi tertentu, misalnya pada penurunan densitas masa tulang pedikel. Teknik insersi sekrup dengan lintasan kortikal diharapkan menambah antarmuka sekrup dan tulang dengan meningkatkan engagement antara sekrup dengan korteks tulang. Lintasan sekrup dari arah kortikal infero-superior serta kortikal supero-inferior diharapkan memiliki keunggulan kekuatan cabut (pullout strength) dibandingkan dengan lintasan konvensional dalam mengatasi masalah ini. Penelitian ini bertujuan untuk mendapatkan profil biomekanik awal lintasan kortikal dan perbedaan pull out strength lintasan konvensional (Weinstein, 1992), kortikal infero-superior (Santoni, 2009), dan kortikal supero-inferior. Metode: Sampel dari lumbal (L1-L5) babi Yorkshire (n=30) dilakukan pengukuran morfometri dan dibagi secara acak. Sampel dilakukan pengeboran dan sekrup dimasukkan ke dalam tulang dengan tiga lintasan: konvensional, kortikal infero-superior, dan kortikal supero-inferior. Arah lintasan diperiksa kembali dengan sinar-x. Dilakukan penarikan sekrup dengan arah sesuai aksis insersi sekrup dengan kecepatan translasi 5mm/menit. Hasil dicatat dengan satuan Newton (N). Hasil: Didapatkan rata-rata nilai uji tarik pada kelompok konvensional, infero-superior, dan supero-inferior masing-masing 491,72 (187.23) N, 822,16 (295.73) N, dan 644,14 (201.97) N. Lintasan kortikal infero-superior dan kortikal supero-inferior masing-masing mendapatkan nilai 67% dan 30% lebih tinggi dibandingkan dengan lintasan konvensional. Hasil uji ANOVA satu arah dan uji post-hoc Tukey menunjukkan perbedaan signifikan antara lintasan kortikal infero-superior dengan konvensional (p<0.01). Kesimpulan: Lintasan sekrup dalam tulang lumbal dapat memengaruhi nilai pullout sekrup. Keterlibatan tulang kortikal pada lintasan insersi sekrup baru ini bisa meningkatkan nilai pullout sekrup pedikel. Secara statistik pullout strength lintasan kortikal infero-superior dan kortikal supero-inferior tidak ada perbedaan. Studi ini menunjukkan nilai pullout yang lebih tinggi sebesar 30% dari lintasan yang disarankan peneliti dibandingkan dengan lintasan konvensional, walaupun tidak ada perbedaan signifikan secara statistik.

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Introduction: Posterior instrumentation is aimed to achieve spinal fusion which is helped by maintaining a stable pedicle screw insertion within the pedicle. This presents a challenge especially in conditions with low bone quality. Pedicle screw insertion with cortical bone trajectory is designed to add interface between the screw and the bone through engagement between pedicles and the cortex when compared to conventional pedicle screw insertion. Pedicle screw insertion trajectory from cortical infero-superior and the proposed cortical supero-inferior should obtain better pull out performance when compared with conventional pedicle trajectory. We aim to evaluate the pull out strength differences between conventional (Weinstein, 1992) pedicle screw trajectory, cortical infero-superior (Santoni, 2009), and a proposed cortical supero-inferior trajectory. Methods: Samples from Yorkshire porcine lumbar spine (L1-L5) (n=30) were relieved of soft tissue attachments and dried. Morphometric measurements were conducted and the samples were randomly assigned to three groups. The screws were inserted into the vertebrae by drilling with the three trajectories: conventional, cortical infero-superior, and cortical supero-inferior. The trajectory of the screws were examined using x-rays. Pull-out tests were conducted by applying uniaxial traction in line with the screw trajectory with a translational speed of 5mm/minutes. The results of the pull-out are measured in Newton (N). Results: We obtained a mean value of pullout force in conventional trajectory 491,72 (187.2) N, cortical infero-superior 822,16 (295.73) N, and cortical supero-inferior 644,14 (201.97) N. Cortical infero-superior trajectory and cortical supero-inferior trajectory attained 67% and 30% higher pullout mean respectively. Using one-way ANOVA and a post-hoc Tukey test revealed a significant difference between cortical infero-superior and conventional trajectory (p<0.01). Differing pull out strengths between cortical infero-superior and supero-inferior trajectory showed no statistical significance. Our study showed a 30% higher pull-out strength in our proposed trajectory compared with conventional trajectory although not statistically significant. Conclusion: The trajectory of the screws within the lumbar spine seemed to have an impact in pullout strength. Cortical bone engagement using the novel trajectories may increase screw pullout strength of pedicle screws."

"ABSTRAKOBJECTIVE: We determined whether the accuracy of thoracaolumbar pedicle screwdirection placement is optimized with a technique using anatomic landmarks forpedicle screw and using S30 as guidance (Technique 1). This technique wascompared with a technique using anatomic landmarks for pedicle screw placementwithout S3D as guidance (Technique 2).METHODS: T7-L1 specimens were harvested from fresh human cadavers. Pediclescrew placement using technique 2 was performed on lelt side. Vertebral rotationand vertebral tilting measurement was determined using S3D. Then pedicle screwplacement using technique 1 was performed on right side. Axial dissections wereperformed on pedicular specimens. Deviation of the screws from the ideal entry pointor trajectory was analyzed to quantitatively compare the two techniques.RESULTS: Axial analysis of the specimens showed that all screw placements werewithin the pedicles. Scatter plot analysis demonstrated that screws placed usingTechnique 2 were more likely to have the combination of entry points andtrajectories medial to the ideal entry point and trajectory.CONCLUSION: All screw placements were grossly within the confines of thepedicles, regardless of technique, as evidenced by axial dissections analysis."

"Saat ini sebagian besar produk implan yang beredar di Indonesia adalah produk impor. Kementerian Kesehatan dan Kementerian Riset,Teknologi,dan Pendidikan Tinggi mendorong produksi produk implan dalam negeri supaya bisa menjadi alternatif produk implan yang selama ini didominasi oleh produk impor. Penelitian ini bertujuan untuk mengetahui kemampuan pullout dan torsi dari screw domestik yang telah dibuat dengan mengacu kepada STM F-543 tentang metode pengetesan untuk screw tulang. Spesifikasi screw yang digunakan dalam penelitian ini adalah screw titanium berukuran M1.5 yang digunakan untuk fiksasi pada area maksilofasial. Performa pullout dicari dengan menggunakan cara eksperimen, finite elemen, dan matematikal. Performa pullout screw domestik kemudian dibandingkan dengan performa screw impor. Sedangkan untuk performa torsi hanya dilakukan dengan cara eksperimen kemudian dibandingkan dengan performa dari screw impor.Hasil yang didapatkan menunjukkan bahwa nilai pull out screw domestik adalah 10,02 N dan screw impor 11,88 N. Nilai screw domestik dibandingkan dengan hasil finite elemen menunjukkan bahwa terjadi error sebesar 10,30. Sedangkan dengan menggunakan analitikal menggunakan chapman yang dimodifikasi didapat nilai sebesar 10,12 N atau error sebesar 1 Dari nilai yang didapat menunjukkan bahwa performa pullout screw domestik lebih buruk dari screw impor. Untuk performa torsi kedua screw menunjukkan performa yang sama baiknya yaitu 0,029 Nm untuk screw domestic dan 0,028 Nm untuk screw impor. Akan tetapi screw domestik membutuhkan gaya yang lebih besar untuk dipasang karena memiliki ujung yang lebih tumpul dari screw impor.

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Currently, the most of implant products that sold at Indonesia are imported product. The Ministry of Health and the Ministry of Research, Technology and Higher Education stimulate domestic implant production as an alternative for imported products that have been dominating domestic market. This study aims to observe domestic titanium screw performance especially from torque and pull out performance based on ASTM F 532 about test method for metallic bone screw. The implant spesification that observed is screw M1.5 for maxillofacial region. Those performances are tested using experimental approach, Finite Element Analysis FEA, and mathematical approach for pull out and only experimental approach for torque test.

The results of this study show that the value of pull out from domestic titanium screw UI and commmercial screw respectively are 10,02 N and 11,88 N. This result for domestic screw UI is not slightly different from result which using FEA approach with error 10,30 for pull out. In the other hands, mathematical approach using chapman modified method give error 1 for pull out. The result of this study shows that the value of pull out performance of domestic titanium screw is a little bit worse than imported commercial product. For torwque performance, domestic screw UI has value 0,029 Nm which is as good as commercial screw with value 0,028 Nm. But, domestic screw needs more force to drive the screw into test block because it has duller tip than commercial screw."

"On March 2nd 2000, a female patient age 47 years, originally had crown & bridges on region 22,,23,24,25,26, region 33,34,35,36,37, region 44,45,46,47. And region 13,14,15,16. She had suffered her abutments teeth as anchorages which initially healthy, then became caries, offtently swelling, pain, halitosis and finally several of its had pulled out. Formerly she asked removable denture on her edentulous ridges, then I had made her Valplast Denture. But the denture still felt uncomfortable and seldom be used. After suggesting the other alternative to use implant denture, on region 35,37 with ITI Straumann to make crown and bridge inplant denture with dummy 36, patient feltsatisfied. Then patient asked another crown and bridges which had problems to be pulled out too. Finally on 5 th February 2008 she had already completely installed combination implant denture ITI Straumann and Biohorizon although it takes along time periode, but now she feels satisfy, because she has fixed denture without sacrifice another healthy teeth as anchorages."

"Kehilangan gigi telah menjadi salah satu permasalahan yang umum untuk ditemukan di Indonesia, dengan angka sekitar 19% kasus gigi hilang akibat dicabut ataupun tanggal sendiri. Untuk mengatasi permasalahan kehilangan gigi, implan gigi merupakan alternatif yang banyak digunakan karena sudah terbukti dapat memberikan hasil yang baik secara jangka panjang. Keberhasilan pemasangan implan gigi dinilai berdasarkan tingkat stabilitasnya, yang terbagi kembali menjadi stabilitas primer dan stabilitas sekunder. Kedua jenis stabilitas tersebut saling berkaitan. Kekhawatiran akan pemasangan implan gigi banyak ditemukan pada kasus dimana pemasangan dilakukan pada pasien dengan tulang berkepadatan rendah. Tulang tempat terpasangnya implan gigi yang memiliki kualitas dan kepadatan yang kurang baik memiliki risiko kegagalan implan yang lebih tinggi. Untuk dapat meningkatkan tingkat stabilitas implan, banyak dilakukan proses modifikasi desain dan permukaan implan gigi, seperti penambahan fitur self-tapping dan peningkatan kekasaran permukaan badan implan. Fabrikasi dilakukan untuk menghasilkan purwarupa implan gigi dengan variasi sudut kemiringan dan panjang cutting flute, sebagai bagian dari fitur self-tapping. Purwarupa akan melalui proses surface treatment untuk mendapatkan tingkat kekasaran yang optimum untuk penggunaannya pada tulang berkepadatan rendah. Purwarupa akan diuji dengan uji torsi insersi dan uji pull-out test. Purwarupa 1 menunjukkan performa terbaik dengan nilai kekasaran permukaan sebesar 1,0636 μm, serta nilai insertion torque value dan pull-out load sebesar 22,4415 Ncm dan 317,068 N.

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Tooth loss has become a common health issue in Indonesia, with approximately 19% of cases resulting from extraction or natural loss. Dental implant are widely used as an alternative due to their proven long-term effectiveness. The success of dental implant placement is evaluated based on its stability, which can be categorized as primary stability and secondary stability. Both types of stability are interrelated with one another. Concerns about dental implant placement are often encountered when dealing with patients with low bone density. Poor quality and low-density bone in the implant insertion site might result in a higher risk of implant failure. To improve implant stability, various modifications are made to the design and surface of the implant body, such as adding self-tapping features and increasing the surface roughness of the implant body. Fabrication is done to produce dental implant prototypes with variations in in angulation and length of the cutting flute, as a part of the self-tapping feature. These prototypes will undergo surface treatment to achieve an optimal level of surface roughness for use in low bone density. Each prototypes are then tested using insertion torque test and pull-out tests. Prototype 1 showed the best performance with a surface roughness value of 1,0636 μm, as well as an insertion torque value of 22,4415 Ncm and a pull-out load of 317,068 N."

"Kondisi kehilangan gigi dapat menyebabkan gangguan pada efisiensi pengunyahan dan berdampak pada penyakit sistemik. Penggunaan implan gigi menjadi perawatan terbaik dengan manfaat jangka panjang. Untuk mencapai kesuksesan pemasangan implan gigi, produk implan gigi harus memiliki desain optimal guna mempercepat proses osseointegrasi. Alternatif yang dapat meningkatkan osseointegrasi dengan memodifikasi permukaan implan yang berpori. Penelitian ini akan berfokus pada simulasi, desain, dan manufaktur dari screw implan gigi berpori dengan prinsip hybrid porous dimana terdiri dari inti implan gigi yang padat dengan permukaan profil ulir yang berpori. Proses manufaktur akan menggunakan metode metal injection molding (MIM) yang melalui tahapan injeksi, debinding, dan sintering. Hasil green part dari injeksi menggunakan feedstock Ti-6Al-4V yang telah dilakukan menunjukkan adanya kecacatan produk pada profil ulir dan short shot. Proses dilanjutkan ke tahap debinding yang terdiri dari solvent debinding dan thermal debinding. Terakhir, proses sintering dilakukan dengan temperatur 1150°C dan waktu tahan 60 menit. Evaluasi pengamatan mikrostruktur dilakukan untuk mengetahui penampakan dari permukaan berpori yang diketahui memiliki %area porositas sebesar 36.268% untuk produk screw Ti-6Al-4V implan gigi trial.

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The condition of tooth loss can disrupt chewing efficiency and have systemic implications. The use of dental implants provides the best long-term treatment option. To achieve successful dental implant placement, the dental implant products must have an optimal design to expedite the osseointegration process. An alternative approach to enhance osseointegration is through modifying the implant surface to incorporate porosity. This study focuses on the simulation, design, and manufacturing of porous screw dental implants using the hybrid porous principle, consisting of a solid core implant with a porous threaded surface. The manufacturing process involves metal injection molding (MIM) with stages of injection, debinding, and sintering. The results of the injection process using Ti-6Al-4V feedstock revealed product defects in the threaded profile and short shots. The process then proceeds to the debinding stage, which includes solvent debinding and thermal debinding. Lastly, sintering is conducted at a temperature of 1150°C and a holding time of 60 minutes. Microstructure observations are performed to examine the appearance of the porous surface, which is known to have a porosity area percentage of 36.268% for the trial Ti-6Al-4V screw dental implant product."

"Implan gigi merupakan perawatan medis bagi gigi tanggal yang diakibatkan oleh berbagai kelainan periodontitis, maupun karies, trauma, serta kelainan pada perkembangan dan genetik, dengan tingkat keberhasilan mencapai 95% ditandai oleh kemampuan implan gigi melakukan osseointegrasi. Osseointegrasi dipengaruhi oleh beberapa hal, termasuk kualitas dan kuantitas tulang, serta desain implan gigi. Kegagalan implan gigi dapat terjadi pada tulang dengan kualitas lebih rendah akibat kelelahan yang berlebihan, serta desain implan gigi yang tidak memadai. Pada beberapa penelitian yang telah dilakukan, menunjukkan bahwa fitur self-tapping memiliki tingkat keberhasilan yang sama dengan implan gigi tanpa fitur ­­self-tapping, namun dengan torsi insersi yang lebih sederhana, sehingga dapat mengurangi risiko kerusakan tulang dan meningkatkan stabilitas primer dengan meminimalisir jumlah drilling yang digunakan. Penelitian ini dilakukan dengan melakukan simulasi finite element pada variasi desain cutting flute, berupa sudut kemiringan celah pemotong, panjang celah pemotong, dan jumlahnya, untuk menjalankan fungsi self-tapping. Simulasi ini dijalankan dengan memberikan pembebanan oklusal pada implan gigi yang dipasang pada tulang berdensitas rendah (tulang tipe III). Dari simulasi tersebut, dilakukan analisis distribusi tegangan dan strain yang terjadi pada implan gigi. Desain implan gigi dengan tiga buah celah pemotong dengan sudut kemiringan 5? di sepanjang badan implan yang berulir memiliki nilai tegangan Von Mises maksimum paling rendah, sebesar 92,127 MPa, bersesuaian dengan nilai strain maksimum paling rendah, yaitu 0,000555.

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Dental implant is a medical treatment for missing tooth caused by various conditions such as periodontitis, cavities, trauma, as well as abnormalities in growth and genetics, with a success rate of up to 95%, characterized by the ability of dental implants to achieve osseointegration. Osseointegration is affected by several factors, including the quality and quantity of bone, as well as the design of dental implants geometry. Dental implants failure can occur in lower quality bone due to excessive fatigue and inadequate implant design for acquired conditions. Research indicates that self-tapping features have the same success rate as dental implants without self-tapping features, but offer simpler insertion torque, reducing the risk of bone damage and improving primary stability by minimizing the drilling procedures. This study was conducted by performing finite element simulations on various cutting flute design, including the angle of the cutting flute, length of the cutting flute, and the number of cutting flute, to provide a self-tapping function. The simulation was conducted by applying occlusal loading to dental implants placed in low-density bone (bone type III). From the simulation, an analysis of stress distribution and strain in dental implants. Among the developed dental implant designs, the one featuring three cutting flutes at a 5? angle along the threaded implant body exhibits the lowest maximum Von Mises stress value of 92,127 MPa, as well as the lowest maximum strain value of 0,000555."

"PendahuluanUntuk menentukan apakah diperlukan fusi tulang belakang disamping dekompresi untuk kasus stenosis spinal lumbar (SSL) akan bergantung kepada stabilitas segmen tulang belakang yang terkena. Stabilitas tulang belakang didefinisikan sebagai kemampuan tulang belakang untuk mempertahankan kemampuan geraknya dengan serta mencegah terjadinya nyeri, defisit neurologis, dan angulasi yang tidak normal. Namun, sampai saat ini, belum ada konsensus yang jelas tentang definisi ketidakstabilan untuk menentukan apakah diperlukan fusi pada kasus SSL. Dalam penelitian ini, kami mengembangkan sistem penilaian baru, yang disebut dengan Indonesia Score of Spinal Instability (ISSI), untuk membantu menentukan adanya ketidakstabilan pada tulang belakang dan mengevaluasi kebutuhan fusi pada LSS.Metodologi Penelitian ini terdiri dari tiga tahap, tahap pertama adalah tinjauan sistematis untuk menemukan prediktor ketidakstabilan tulang belakang pada SSL, tahap kedua adalah pengembangan sistem penilaian untuk ketidakstabilan tulang belakang - Indonesia Score of Spinal Instability (ISSI) melalui pendapat ahli dan teknik Delphi yang dimodifikasi, dan tahap ketiga adalah studi validitas dan reliabilitas sistem penilaian yang baru dikembangkan. Tinjauan sistematis dilakukan dengan menggunakan pedoman dari Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Pendapat ahli dan teknik Delphi yang dimodifikasi dilakukan oleh ahli bedah tulang belakang berpengalaman di Indonesia yang telah terpilih, tahap ini dilakukan dua kali untuk menilai apakah ada perbedaan antara putaran pertama dan kedua. Tahap kedua akan menghasilkan ISSI yang baru. Pengujian validitas dan reliabilitas dilakukan di rumah sakit institusional kami, yang melibatkan ahli bedah Ortopedi dan Ahli Radiologi yang bersertifikasi dan dibandingkan dengan penilaian radiologis dari White & Panjabi.HasilSebanyak 54 studi dimasukkan dalam tinjauan sistematis, dan prediktor ketidakstabilan pada stenosis tulang belakang dibagi menjadi klinis (adanya nyeri punggung sebagai gejala primer atau sekunder), radiografi polos statis (adanya vacuum phenomenon, kolaps diskus intervertebralis, sklerosis subkondral, dan traction spur), radiografi polos dinamik (translasi dan angulasi dinamik), dan temuan pencitraan resonansi magnetik/ (magnetic resonance imaging, MRI) yang terdiri dari efusi sendi faset, degenerasi otot multifidus, degenerasi endplate, dan degenerasi diskus. Melalui pendapat para ahli dan teknik Delphi yang dimodifikasi, penilaian ISSI dikembangkan dan terdiri dari komponen klinis (nyeri punggung), komponen radiografi dinamik (translasi horizontal dan angulasi), dan komponen MRI (efusi sendi faset), masing- masing komponen tersebut akan diberi nilai, dan total nilai adalah 0 hingga 14. Penilaian akhir akan mengklasifikasikan pasien ke dalam tiga kelompok: kelompok stabil (nilai 0 hingga 4) di mana fusi tidak diperlukan, kelompok berpotensi tidak stabil (nilai 5 hingga 8) di mana keputusan fusi didasarkan pada penilaian klinis dokter bedah, dan kelompok tidak stabil (nilai 9 hingga 14) di mana fusi diperlukan. Tahap akhir penelitian menyimpulkan bahwa ISSI ini memiliki validitas dan reliabilitas yang baik.Diskusi dan KesimpulanISSI yang baru dikembangkan adalah sistem penilaian ketidakstabilan tulang belakang pada kasus SLL degeneratif yang sahih (valid) dan dapat diandalkan (reliabel), yang dapat membantu mengidentifikasi adanya ketidakstabilan pada SSL degenratif. ISSI diharapkan dapat digunakan sebagai pedoman untuk memutuskan apakah fusi tulang belakang diperlukan.

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Introduction

Whether spinal fusion is performed in addition to a decompression for lumbar spinal stenosis (LSS) depends on the stability of the involved spinal segments. Spinal stability is defined as the ability of the spine to maintain its degree of motion while simultaneously preventing pain, neurologic deficits, and abnormal angulation. However, until currently, there is no clear consensus regarding the definition of instability to perform fusion in the cases of LSS. We developed a new scoring system, the Indonesia Score of Spinal Instability (ISSI), to identify spinal instability and to evaluate the need of spinal fusion in LSS.

Materials and Methods

This study consisted of three stages, the first stage was the systematic review to find predictors of spinal instability in LSS, the second stage was the development of scoring system for spinal instability – the Indonesia Score of Spinal Instability (ISSI) through expert opinion and modified Delphi technique, and the third stage was validity and reliability studies of the new developed scoring system. The systematic review was performed through Preferred Reporting Items for Systematic Reviews and Meta- Analyses (PRISMA) guideline. Expert opinion and modified Delphi technique were performed by experience spine surgeons in Indonesia who had been elected, this stage was performed twice to assess whether there was difference between first and second rounds. The second stage would yield the new developing ISSI. Validity and reliability testing were performed in our institutional hospitals, which included the board-certified Orthopaedic surgeon and Radiologist and was compared with the radiological checklist from White & Panjabi.

Results

A total of 54 studies were included in the systematic reviews, and the predictors of instability in spinal stenosis were divided into clinical (presence of back pain as primary or secondary symptoms), static plain radiograph (presence of vacuum phenomenon, intervertebral disk collapse, subchondral sclerosis, and traction spurs), dynamic plain radiograph (horizontal translation and angulation), and magnetic resonance imaging/ MRI findings (facet joint effusion, fatty degeneration of multifidus, endplate degeneration, and disk degeneration). Through expert opinion and modified Delphi technique, ISSI score was developed and consisted of the clinical component (back pain), dynamic radiograph component (horizontal translation and angulation), and MRI component (facet joint effusion), each of the component would be scored, and the total scoring would be from 0 to 14. The final scoring would classify patients into three groups: stable group (score of 0 to 4) in which the fusion is not needed, potentially unstable group (score of 5 to 8) in which the decision of fusion is based on surgeon’s clinical judgment, and unstable group (score of 9 to 14) in which the fusion is needed. Final stage of study concluded that this ISSI had good reliability and validity

Discussion and Conclusion

The new developed ISSI was a valid and reliable scoring system that could help to identify the presence of instability in LSS and the need of fusion. This ISSI can be used as a guideline to decide whether spinal fusion would be needed."

"Latar belakang: Gigi tiruan dukungan implan, salah satu perawatan kehilangan gigi terbaik, diterima luas di seluruh dunia. Namun, penggunaannya di Indonesia masih relatif rendah. Studi terkait kesadaran (awareness), pengetahuan (knowledge), dan sikap (attitude) terhadap implan gigi telah banyak dilakukan di negara lain, tetapi belum pernah dilakukan di Indonesia. Tujuan: Mengembangkan kuesioner kesadaran, pengetahuan, dan sikap pasien terhadap implan gigi yang valid dan reliabel. Metode: Penelitian kualitatif melalui studi literatur pada 9 studi, wawancara semi-struktur 8 pakar implan dan 10 subjek kehilangan gigi, focus group discussion, dan uji-coba kuesioner. Penelitian kuantitatif pada 227 subjek untuk pengujian validitas dan reliabilitas kuesioner. Hasil: Kuesioner final 28 item (domain kesadaran, pengetahuan, dan sikap) berhasil dikembangkan dengan validitas isi (content validity) dan validitas muka (face validity) terpenuhi. Analisis faktor dapat dilakukan pada ketiga domain berdasarkan hasil Uji Kaiser-Meyer Olkin (KMO) dan Uji Bartlett (0,680;P<0,05| 0,922;P<0,05| 0,849;P<0,05). Uji validitas konvergen dan uji konsistensi internal Cronbach’s alpha menghasilkan nilai baik pada domain kesadaran (r=0,736; P<0,05; α=0,848), domain pengetahuan (r=0,616; P<0,05; α=0,922), dan domain sikap (r=0,658; P<0,05; α=0,794). Kesimpulan: Kuesioner kesadaran, pengetahuan, dan sikap pasien terhadap perawatan dengan implan gigi teruji valid dan reliabel untuk mengevaluasi kesadaran, pengetahuan, dan sikap pasien terhadap perawatan dengan implan gigi di Indonesia.

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Background: Implant-supported prosthesis, one of the best treatment for tooth loss, are widely accepted worldwide. However, its utilization is still relatively low in Indonesia. Studies related to awareness, knowledge, and attitude towards dental implants have been conducted in many other countries, but there has been no study in Indonesia. Objective: To develop a valid and reliable questionnaire on patient awareness, knowledge and attitudes towards dental implants. Methods: Qualitative study was done through literature review on 9 studies, semi-structured interviews with 8 implant experts and 10 tooth loss subjects, focus group discussion, and pre-testing. Quantitative study on 227 subjects for validity and reliability test. Results: The final questionnaire of 28 items (awareness, knowledge, and attitude domains) was successfully developed with achieved content validity and face validity. Factor analysis can be performed on all three domains based on the results of the Kaiser-Meyer-Olkin Test (KMO) and Bartlett Test (0.680;P<0.05| 0.922;P<0.05| 0.849;P<0.05). The convergent validity and Cronbach's alpha internal consistency were high in awareness domain (r=0.736; P<0.05; α=0.848), knowledge domain (r=0.616; P<0.05; α=0.922), and attitude domain (r=0.658; P<0.05; α=0.794). Conclusion: The questionnaire developed was valid and reliable to evaluate patient awareness, knowledge, and attitudes towards dental implant treatment in Indonesia."