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"ABSTRAKPendahuluan: Pada penelitian yang telah dilakukan sebelumnya, zoledronate bisphosphonate dalam bentuk gel emulsi telah terbukti meningkatkan jumlah apoptosis sel osteoklas. Aplikasi topikal dalam bentuk gel telah banyak digunakan pada rongga mulut. Tujuan dari penelitian ini adalah untuk mengetahui stabilitas fisik gel zoledronate bisphosphonate sebagai salah satu syarat dalam pengembangan produk baru.Metode: Formulasi gel zoledronate dibuat dari carboxylmethylcellulose (CMC), gliserin, dan sodium benzoat dengan dosis 40 μg zoledronate dalam setiap 25 mg gel. Gel disimpan pada suhu 25°C dan 40°C selama 28 hari dan dievaluasi viskositas, pH, daya sebar, daya lekat, dan kadar obat pada awal, hari ke-7, hari ke-14, dan hari ke-28.Hasil: Pada penyimpanan suhu 25°C, uji repeated measure ANOVA menunjukkan tidak terdapat perbedaan bermakna secara statistik pada parameter viskositas, daya sebar, dan daya lekat antar waktu penyimpanan (p>0,05). Pada parameter kadar obat dan pH, terdapat perbedaan yang bermakna secara statistik (p<0,05) namun secara kuantatif masih dalam batas normal. Sementara pada hari ke-28 penyimpanan suhu 40°C, gel mengeras sehingga pengujian hanya dilakukan pada hari ke-7 dan ke-14. Terdapat perbedaan yang bermakna secara statistik pada semua parameter uji stabilitas (p<0,05) antar waktu pengamatan pada suhu 40°C. Hasil uji t-test independent menunjukkan tidak terdapat perbedaan bermakna secara statistik pada semua parameter (p>0,05) antar suhu penyimpanan pada hari ke-7 dan ke-14.Kesimpulan: Nilai viskositas, daya sebar, daya lekat, kadar obat, dan pH gel zoledronate stabil selama 28 hari pada suhu penyimpanan 25°C. Pada suhu 40°C setelah hari ke-14, gel zoledronate menjadi tidak stabil karena konsistensi gel mengeras pada hari ke-28.

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ABSTRACT

Introduction: In the previous study, topical application of zoledronate bisphosphonate in gel emulsion has been proven to increase the number of osteoclasts apoptosis. In the oral cavity, topical application is commonly used in gel form; therefore, this study was conducted to evaluate the physical stability of zoledronate bisphosphonate in gel form as one of the prerequisites in developing a new drug product.

Methods: The gel formulation was prepared using carboxylmethylcellulose (CMC), glycerine, and sodium benzoate in a dosage form of 40 μg zoledronate in every 25 mg gel. The gels were stored at 25°C and 40°C for 28 days and evaluated for viscosity, pH value, spreadability, adhesive strength, and drug content on the 1st day, 7th day, 14th day, and 28th day.

Results: At the 25°C of storage, repeated measure ANOVA test shows no statistically significant changes in viscosity, spreadability, and adhesive strength between the 7th, 14th, and 28th day (p>0,05). The changes in drug content and pH value were statistically significant (p<0,05) but quantitatively still in the normal range. Meanwhile, on the 28th day at the 40°C of storage, the gel hardened; therefore, the stability test could only be performed on the 7th and 14th day. There were statistically significant changes in all parameters (p<0,05) between the 7th, 14th, and 28th day at 40°C. The t-test independent shows no statistically significant changes in all parameters (p>0,05) between the 25°C and 40°C of storage on the 7th and 14th day.

Conclusion: The zoledronate bisphosphonate gel was stable in viscosity, spreadability, adhesive strength, drug content, and pH value at 25°C for 28 days. At 40°C of storage, zoledronate gel was unstable after 14 days because the consistency of the gel hardened on the 28th day."

"Latar Belakang: Tingkat keberhasilan dan stabilitas jangka panjang dari perawatan menggunakan alat ortodontik cekat dapat dipengaruhi oleh beberapa faktor, seperti mekanisme biomekanik dan biologis yang mendasari pergerakan gigi ortodontik. Penelitian terdahulu menunjukkan adanya keterkaitan antara faktor keberhasilan perawatan ortodontik dan ekspresi gen, seperti gen TIMP-1 yang berperan dalam pergerakan gigi ortodontik. Tissue inhibitor of metalloproteinase (TIMP) merupakan kelas penghambat MMP (TIMP-1, -2, -3, dan -4) yang dapat menghambat hampir setiap MMP secara nonspesifik. MMP dan TIMP terlibat dalam pergantian fisiologis jaringan periodontal dan dianggap memainkan peran penting dalam pergerakan gigi ortodontik. Penelitian ini dilakukan untuk memvalidasi perbedaan ekspresi gen pada pengguna alat ortodontik cekat dibandingkan dengan kontrol. Tujuan: Menganalisis ekspresi gen pada pengguna alat ortodontik cekat dibandingkan dengan individu sehat yang tidak menggunakan alat ortodontik cekat. Metode: Sampel penelitian ini menggunakan sampel buccal swab pada pengguna alat ortodontik cekat, masing-masing 61 sampel untuk sampel buccal swab dari tiap pengguna alat ortodontik cekat serta 30 sampel kontrol dari individu sehat. Kemudian dilakukan ekstraksi RNA dan sintesis cDNA pada masing-masing sampel. Setelah itu, ekspresi gen TIMP-1 dan gen referensi GAPDH diuji menggunakan quantitative reverse-transcription PCR (RT-qPCR), Hasil: Tidak ada perbedaan ekspresi relatif gen TIMP-1 antara pengguna alat ortodontik cekat dan kontrol yang bermakna secara statistik (p≥0,05). Kesimpulan: Tidak terdapat perbedaan ekspresi gen TIMP-1 yang signifikan pada pengguna alat ortodontik cekat dibandingkan dengan individu sehat.

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Background: The success rate and long-term stability of treatment using fixed orthodontic appliances can be influenced by several factors, such as the biomechanical and biological mechanisms that underlie orthodontic tooth movement. Previous studies have shown that there is a link between success factors for orthodontic treatment and gene expression, such as the TIMP-1 gene, which plays a role in orthodontic tooth movement. Tissue inhibitors of metalloproteinase (TIMP) are a class of MMP inhibitors that can inhibit almost every MMP nonspecifically. MMP and TIMP are involved in the physiological turnover of the periodontal tissues and are considered to play an important role in orthodontic tooth movement. This study was conducted to validate differences in gene expression in fixed orthodontic appliance patients compared to controls. Objective: To analyze gene expression in fixed orthodontic appliance patients compared to healthy individuals who do not use fixed orthodontic appliance. Methods: The sample of this study used buccal swab samples in patients who used certain materials for treatment in dentistry, namely fixed orthodontic appliances, 61 samples for each patient's buccal swab samples and 30 control samples from healthy individuals. Then, RNA extraction and cDNA synthesis is performed in each sample. Furthermore, the expression of the TIMP-1 gene and the GAPDH reference gene were tested using quantitative reverse-transcription PCR (RT-qPCR). Results: There was no statistically significant difference in the relative expression of the TIMP-1 gene between fixed orthodontic appliance patients and healthy patients (p≥0.05). Conclusion: There was no significant difference in TIMP-1 gene expression in patients with fixed orthodontic appliances compared to healthy patients.

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"Latar Belakang: Zoledronat merupakan jenis obat bisfosfonat yang paling kuat dalam menghambat resorpsi tulang. Zoledronat terbukti dapat menghambat pergerakan gigi ortodonti dan memperkuat penjangkaran maksimum, pada studi hewan. Sebagian besar studi masih menggunakan obat zoledronat dalam bentuk injeksi. Sediaan topikal mulai dikembangkan untuk mengatasi permasalahan yang ditimbulkan melalui pemberian obat secara injeksi Gel dan emulsi gel (emulgel) merupakan jenis sediaan obat topikal semi padat. Uji stabilitas suatu produk farmasi perlu dilakukan untuk menilai kemampuan suatu formulasi dalam mempertahankan sifat dan karakteristiknya saat pengemasan selama periode penyimpanan dan penggunaan. Penelitian ini bertujuan untuk membandingkan stabilitas fisik gel dan emulgel zoledronat yang disimpan pada suhu ruang (28±2°C) dan akselerasi (40°C) selama 8 minggu pengamatan. Metode penelitian: Gel dan emulgel disimpan selama 8 minggu pada suhu 28±2°C dan 40°C. Parameter stabilitas fisik yang dilihat antara lain organoleptis, pH, daya sebar, viskositas dan ukuran globul emulgel. Evaluasi dilakukan pada hari pertama, minggu ke-2,4,6 dan 8. Hasil: Terdapat perbedaan bermakna secara statistik pada seluruh parameter antar sediaan gel dan emulgel pada setiap waktu pengamatan. Pada sediaan emulgel yang disimpan di suhu 28±2°C, tidak terdapat perbedaan bermakna pada parameter viskositas, daya sebar dan ukuran globul selama 8 minggu pengamatan. Pada sediaan gel yang disimpan pada suhu 28±2°C, terdapat perbedaan bermakna pada seluruh parameter selama 8 minggu pengamatan. Kesimpulan: Emulgel zoledronat yang disimpan pada suhu 28±2°C selama 8 minggu stabil menurut semua parameter-parameter fisik yang diuji, kecuali pH. Perubahan pada nilai pH masih dekat dengan kisaran normal pH pada rongga mulut. Selain itu, gel zoledronat yang disimpan pada suhu 28±2°C selama 8 minggu dapat disimpulkan tidak stabil.

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Introduction: Zoledronate is the most potent bisphosphonate at inhibiting bone resorption. Zoledronate has been shown to inhibit orthodontic tooth movement and increase maximum anchorage in animal studies. Most studies are still using zoledronate in injectable form. The strategy to overcome problems associated with drug administration by injection is to develop zoledonate that can be administered topically. Gel and emulsion gel (emulgel) are a semi-solid drug preparation. Stability testing of pharmaceutical product must be done to evaluate the capability of a particular formulation to retain its properties and characteristics at the time of packaging throughout its period of storage and use. This study aims to compare the physical stability of zoledronat gel and emulgel stored in room temperature (28±2°C) and accelerated temperature (40°C) for eight weeks. Methods: Gel and emulgel were stored in room temperature (28±2°C) and accelerated temperature (40°C) for eight weeks. The physical stability parameters that were used in this study is organoleptic, pH, spreadability, viscosity and globule size diameter for emulgel preparation. Gel and emulgel were evaluated on the first day, 2nd week, 4th week, 6th week and 8th week. Results: There were statistically significant differences in all stability parameters, except pH, between gel and emulgel prepatations. For emulgel preparations that was stored in room temperature, there was no statistically significant differences in viscosity, spreadability and globule size diameter during eight weeks of observation. For gel preparations that was stored in room temperature, there were significant differences in all stability parameters during eight week of observation. Conclusion: According to the parameters in physical stability test, except pH, zoledronate emulgel stable in room temperature (28±2°C) storage for eight week observation. The changes in pH values was near from normal pH range in oral cavity. Other than that, zoledronate gel was not stable in room temperature (28±2°C) storage for eight week observation."

"Fase awal pergerakan gigi ortodontik diawali dengan respon inflamasi akut. Proses ini menimbulkan respon dari sel paradental dan sel pertahanan tubuh dengan mensintesis dan melepaskan berbagai biomolekul seperti sitokin. Tumor necrosis factor-a TNF-? merupakan sitokin pro-inflamasi penting yang meregulasi respon awal inflamasi pada pergerakan gigi ortodontik. Tujuan dari penelitian ini adalah untuk menganalisis ekspresi TNF-? dengan membandingkan konsentrasinya pada gingival crevicular fluid GCF antara sistem self-ligating SL dan preadjusted edgewise appliance PEA pada tahap awal perawatan. Metode: Delapan belas pasien usia 15-35 tahun yang berpartisipasi dalam penelitian ini dibagi menjadi dua kelompok eksperimental PEA dan SL dan satu kelompok kontrol tanpa perawatan ortodontik. Pasien dipilih berdasarkan kriteria inklusi: indeks iregularitas Little sebesar 4-9 mm pada anterior maksila dengan indikasi perawatan non-ekstrakasi serta tanpa karies aktif, penyakit periodontal, dan penyakit sistemik terkait kerusakan tulang. Cairan krevikular gingiva subjek diambil pada lima titik di anterior maksila sebelum perawatan dan pada: 1, 24, dan 168 jam setelah aplikasi gaya ortodontik. Konsentrasi TNF-? pada sampel GCF diperiksa menggunakan metode enzyme-linked immunoabsorbent assay ELISA. Hasil: Konsentrasi TNF-? meningkat pada 1 jam dan 24 jam setelah aplikasi gaya ortodontik pada kedua sistem baik pada kelompok SL dan PEA. Konsentrasi TNF-? menurun signifikan pada 168 jam setelah aplikasi gaya ortodontik pada kelompok PEA. Sementara itu, pada kelompok SL konsentrasi TNF-? pada 168 jam tetap meningkat walaupun secara statistik tidak signifikan. Kesimpulan: Konsentrasi TNF-? meningkat pada 1 jam dan 24 jam setelah aplikasi gaya ortodontik pada kelompok PEA dan SL. Pada kelopok PEA, konsentrasi TNF-? menurun signifikaan pada 168 jam, sedangkan pada kelompok SL konsentrasi TNF-? tetap meningkat. Perbedaan konsentrasi TNF-? antara kelompok PEA dan SL mungkin disebabkan oleh perbedaan braket, kawat, dan sistem ligasi yang digunakan antara kedua sistem tersebut.

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The early phase of orthodontic tooth movement begins with acute inflammation response. This processes engender a response on the part of paradental cells and migrating inflammatory cells from periodontal ligament capillaries via the synthesis and release of various biomolecules such as cytokines. Tumor necrosis factor a TNF is an important pro inflammatory cytokine that regulates the early phase of inflammation reaction during orthodontic tooth movement. The aim of the present study was to analyze TNF expression by comparing its concentrations in the gingival crevicular fluid GCF between self ligating SL and preadjusted edgewise appliance PEA systems during the early levelling stage of orthodontic treatment.

Methods: Eighteen patients aged 15 35 years who participated in this study were divided into two experimental groups PEA and SL and control group without orthodontic treatment. Patients were selected according to the inclusion criteria Little irregularity index on maxillary anterior teeth ranging from 4 9 mm non extraction orthodontic treatment for the experimental group no active dental caries, periodontitis, and medical history of bone disorder. The GCF was taken at five sites in the maxilla anterior teeth from each subject just before bracket bonding and at 1, 24, and 168 hours after orthodontic force application. TNF levels in GCF were determined by enzyme linked immunoabsorbent assay ELISA.

Results: The concentration of TNF was significantly higher in the experimental groups than in the control group at 24 hours after force application. TNF levels were significantly decreased at 168 hours after force application in the PEA group. Meanwhile, in the SL group, the level of TNF at 168 hours was still increased, although there was no statistically significant difference.

Conclusion: TNF concentration was increased at 1 hour and 24 hours after orthodontic force application in both the PEA and SL groups. In the PEA group, TNF concentration was significantly decreased at 168 hours, meanwhile in the SL group, this value remained increased at this time point. The differences in TNF concentration between the PEA and SL groups may be caused by their different types of brackets, wires, and ligation methods."