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Efficacy of Negative-Pressure Wound Therapy with Tetrachlorodecaoxygen-Anion Complex Instillation Compared with Standard Negative-Pressure Wound Therapy for Accelerated Wound Healing: A Prospective, Randomized, Controlled Trial.
Burusapat, C, Sringkarawat, S
Plastic and reconstructive surgery. 2021;(2):339-352
Abstract
BACKGROUND Negative-pressure wound therapy (NPWT) with instillation is a novel wound therapy. The optimal solution is still being investigated. Tetrachlorodecaoxygen-anion complex (TCDO) causes increased phagocytosis and oxygenation. The authors' objective was to investigate the efficacy of NPWT with TCDO instillation (NPWTi) and to compare the results with NPWT alone. METHODS A randomized controlled trial was conducted. Inclusion criteria were wound size greater than 4 cm2 and depth greater than 10 mm. Exclusion criteria were malignancy, immunocompromise, and allergy to TCDO. Patients were randomized into NPWT and NPWTi groups. Outcome measurements consisted of wound surface area, depth, volume, tissue culture, and pathologic evaluation. RESULTS A total of 24 patients in each group were enrolled. The percentages of wound surface area reduction of NPWTi and NPWT groups were 24.1 ± 6.8 and 28.2 ± 7.6 on day 12, and 19.0 ± 6.6 and 22.7 ± 7.8 on day 15, respectively (p < 0.05). The percentages of wound depth reduction were 16.4 ± 5.3 and 22.5 ± 10.5 on day 12, and 12.0 ± 6.7 and 14.1 ± 8.0 on day 15, respectively (p < 0.05). The percentages of wound volume reduction were 17.9 ± 4.6 and 21.6 ± 5.8 on day 12, and 14.7 ± 6.0 and 17.1 ± 6.6 on day 15, respectively (p < 0.05). No statistically significant difference in microbial reduction was found between the groups. Histopathologic examination showed that more angiogenesis was observed in the NPWTi group than in the NPWT group. CONCLUSIONS NPWT with TCDO instillation statistically significantly accelerated wound healing, but it did not show significant microbial reduction. The authors' results suggest that TCDO instillation may be an adjunctive treatment in NPWT. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.
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A Randomized Trial of Magnesium Oxide and Oral Carbon Adsorbent for Coronary Artery Calcification in Predialysis CKD.
Sakaguchi, Y, Hamano, T, Obi, Y, Monden, C, Oka, T, Yamaguchi, S, Matsui, I, Hashimoto, N, Matsumoto, A, Shimada, K, et al
Journal of the American Society of Nephrology : JASN. 2019;(6):1073-1085
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BACKGROUND Developing strategies for managing coronary artery calcification (CAC) in patients with CKD is an important clinical challenge. Experimental studies have demonstrated that magnesium inhibits vascular calcification, whereas the uremic toxin indoxyl sulfate aggravates it. METHODS To assess the efficacy of magnesium oxide (MgO) and/or the oral carbon adsorbent AST-120 for slowing CAC progression in CKD, we conducted a 2-year, open-label, randomized, controlled trial, enrolling patients with stage 3-4 CKD with risk factors for CAC (diabetes mellitus, history of cardiovascular disease, high LDL cholesterol, or smoking). Using a two-by-two factorial design, we randomly assigned patients to an MgO group or a control group, and to an AST-120 group or a control group. The primary outcome was percentage change in CAC score. RESULTS We terminated the study prematurely after an interim analysis with the first 125 enrolled patients (of whom 96 completed the study) showed that the median change in CAC score was significantly smaller for MgO versus control (11.3% versus 39.5%). The proportion of patients with an annualized percentage change in CAC score of ≥15% was also significantly lower for MgO compared with control (23.9% versus 62.0%). However, MgO did not suppress the progression of thoracic aorta calcification. The MgO group's dropout rate was higher than that of the control group (27% versus 17%), primarily due to diarrhea. The percentage change in CAC score did not differ significantly between the AST-120 and control groups. CONCLUSIONS MgO, but not AST-120, appears to be effective in slowing CAC progression. Larger-scale trials are warranted to confirm these findings.
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The evaluation of MTA and Biodentine as a pulpotomy materials for carious exposures in primary teeth.
Çelik, BN, Mutluay, MS, Arıkan, V, Sarı, Ş
Clinical oral investigations. 2019;(2):661-666
Abstract
OBJECTIVE This study examined the effects of MTA and Biodentine on the clinical and radiographic success rates of pulpotomies performed on primary teeth with carious pulp exposures. MATERIALS AND METHODS This study was conducted with 44 mandibular primary molars requiring vital pulpotomy. Carious dentin surrounding the exposure site was used as the inclusion criteria for all teeth, which were randomly divided into two groups according to pulpotomy material [MTA group (n = 24), Biodentine group (n = 20)]. Treatment was followed up clinically and radiologically for 24 months. Pulp canal obliteration was not regarded as a failure. RESULTS Clinical and radiographic success rates at the end of 24 months were 100% for the MTA group and 89.4% for the Biodentine group. Success rates did not vary significantly between the groups (p = 0.646). Pulp canal obliteration was observed in two teeth (8.3%) in the MTA group at 6 months, but the teeth were found to be stabilized by 24 months. CONCLUSION The long-term clinical and radiographic success rates obtained in this study indicate that both MTA and Biodentine are appropriate options for pulpotomy treatment of primary teeth with carious exposure in patients whose teeth should be retained for long periods of time. CLINICAL RELEVANCE The etiology of exposure determines pulpal response, making it crucial to distinguish between mechanical and carious exposures. The carious exposure is presumed to be accompanied by severe inflammation, which makes the prognosis of treatment unpredictable. Biomaterials can be used especially in cases with carious pulp exposures.
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Comparison between calcium hydroxide mixtures and mineral trioxide aggregate in primary teeth pulpotomy: a randomized controlled trial.
Silva, LLCE, Cosme-Silva, L, Sakai, VT, Lopes, CS, Silveira, APPD, Moretti Neto, RT, Gomes-Filho, JE, Oliveira, TM, Moretti, ABDS
Journal of applied oral science : revista FOB. 2019;:e20180030
Abstract
OBJECTIVES To evaluate the effect of calcium hydroxide (CH) associated with two different vehicles as a capping material for pulp tissue in primary molars, compared with mineral trioxide aggregate (MTA). METHODOLOGY Forty-five primary mandibular molars with dental caries were treated by conventional pulpotomy using one of the following materials: MTA only (MTA group), CH with saline (CH+saline group) and CH with polyethylene glycol (CH+PEG group) (15 teeth/group). Clinical and periapical radiographic examinations of the pulpotomized teeth were performed 3, 6, and 12 months after treatment. Data were tested by chi-squared analysis and a multiple comparison post-test. RESULTS The MTA group showed both clinical and radiographic treatment success in 14/14 teeth (100%), at all follow-up appointments. By clinical evaluation, no teeth in the CH+saline and CH+PEG groups had signs of mobility, fistula, swelling or inflammation of the surrounding gingival tissue. However, in the CH+saline group, radiographic analysis detected internal resorption in up to 9/15 teeth (67%), and inter-radicular bone resorption and furcation radiolucency in up to 5/15 teeth (36%), from 3 to 12 months of follow-up. In the CH+PEG group, 2/11 teeth (18%) had internal resorption and 1/11 teeth (9%) presented bone resorption and furcation radiolucency at all follow-up appointments. CONCLUSION CH with PEG performed better than CH with saline as capping material for pulpotomy of primary teeth. However, both combinations yielded clinical and radiographic results inferior to those of MTA alone.
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NBTXR3, a first-in-class radioenhancer hafnium oxide nanoparticle, plus radiotherapy versus radiotherapy alone in patients with locally advanced soft-tissue sarcoma (Act.In.Sarc): a multicentre, phase 2-3, randomised, controlled trial.
Bonvalot, S, Rutkowski, PL, Thariat, J, Carrère, S, Ducassou, A, Sunyach, MP, Agoston, P, Hong, A, Mervoyer, A, Rastrelli, M, et al
The Lancet. Oncology. 2019;(8):1148-1159
Abstract
BACKGROUND Pathological complete response to preoperative treatment in adults with soft-tissue sarcoma can be achieved in only a few patients receiving radiotherapy. This phase 2-3 trial evaluated the safety and efficacy of the hafnium oxide (HfO2) nanoparticle NBTXR3 activated by radiotherapy versus radiotherapy alone as a pre-operative treatment in patients with locally advanced soft-tissue sarcoma. METHODS Act.In.Sarc is a phase 2-3 randomised, multicentre, international trial. Adults (aged ≥18 years) with locally advanced soft-tissue sarcoma of the extremity or trunk wall, of any histological grade, and requiring preoperative radiotherapy were included. Patients had to have a WHO performance status of 0-2 and a life expectancy of at least 6 months. Patients were randomly assigned (1:1) by an interactive web response system to receive either NBTXR3 (volume corresponding to 10% of baseline tumour volume at a fixed concentration of 53·3 g/L) as a single intratumoural administration before preoperative external-beam radiotherapy (50 Gy in 25 fractions) or radiotherapy alone, followed by surgery. Randomisation was stratified by histological subtype (myxoid liposarcoma vs others). This was an open-label study. The primary endpoint was the proportion of patients with a pathological complete response, assessed by a central pathology review board following European Organisation for Research and Treatment of Cancer guidelines in the intention-to-treat population full analysis set. Safety analyses were done in all patients who received at least one puncture and injection of NBTXR3 or at least one dose of radiotherapy. This study is registered with ClinicalTrials.gov, number NCT02379845, and is ongoing for long-term follow-up, but recruitment is complete. FINDINGS Between March 3, 2015, and Nov 21, 2017, 180 eligible patients were enrolled and randomly assigned and 179 started treatment: 89 in the NBTXR3 plus radiotherapy group and 90 in the radiotherapy alone group. Two patients in the NBTXR3 group and one patient in the radiotherapy group were excluded from the efficacy analysis because they were subsequently discovered to be ineligible; thus, a total of 176 patients were analysed for the primary endpoint in the intention-to-treat full analysis set (87 in the NBTXR3 group and 89 in the radiotherapy alone group). A pathological complete response was noted in 14 (16%) of 87 patients in the NBTXR3 group and seven (8%) of 89 in the radiotherapy alone group (p=0·044). In both treatment groups, the most common grade 3-4 treatment-emergent adverse event was postoperative wound complication (eight [9%] of 89 patients in the NBTXR3 group and eight [9%] of 90 in the radiotherapy alone group). The most common grade 3-4 adverse events related to NBTXR3 administration were injection site pain (four [4%] of 89) and hypotension (four [4%]) and the most common grade 3-4 radiotherapy-related adverse event was radiation skin injury in both groups (five [6%] of 89 in the NBTXR3 group and four [4%] of 90 in the radiotherapy alone group). The most common treatment-emergent grade 3-4 adverse event related to NBTXR3 was hypotension (six [7%] of 89 patients). Serious adverse events were observed in 35 (39%) of 89 patients in the NBTXR3 group and 27 (30%) of 90 patients in the radiotherapy alone group. No treatment-related deaths occurred. INTERPRETATION This trial validates the mode of action of this new class of radioenhancer, which potentially opens a large field of clinical applications in soft-tissue sarcoma and possibly other cancers. FUNDING Nanobiotix SA.
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Mineral Trioxide Aggregate Partial Pulpotomy Versus Formocresol Pulpotomy: A Randomized, Split-Mouth, Controlled Clinical Trial with 24 Months Follow-Up.
Nematollahi, H, Noorollahian, H, Bagherian, A, Yarbakht, M, Nematollahi, S
Pediatric dentistry. 2018;(3):184-189
Abstract
PURPOSE The purpose of this study was to evaluate the clinical and radiographic success rates of mineral trioxide aggregate partial pulpotomy (PP) compared to formocresol pulpotomy (FP) in human primary molars. METHODS In this randomized, controlled, split-mouth, clinical trial, 25 healthy five- to eight-year-olds, with 50 carious primary mandibular second molars lacking clinical and radiographic evidence of pulp pathology, were selected. The selected teeth were randomly assigned into two groups, PP and FP, for vital pulp therapy. Stainless steel crowns were placed as final restorations for both groups. Clinical and radiographic evaluation at six, 12, and 24 months used the following criteria for failure: pain; swelling; sinus tract; mobility; internal or external root resorption; furcation or periapical radiolucency; and widening of periodontal ligament space. The data were analyzed using a binary logistic generalized estimating equation model. RESULTS At the 12-month and 24-month follow-ups, one child and three children, respectively, were lost to follow-up. At the 24-month follow-up, the clinical, radiographic, and overall success rates of PP were 90.9 percent, 90.5 percent, and 81.8 percent versus FP success of 100 percent, 95.2 percent, and 95.2 percent, respectively. CONCLUSION There were no significant differences between clinical, radiographic, and overall success rate of mineral trioxide aggregate partial pulpotomy and formocresol pulpotomy overall 24 months.
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Response of periodontium to mineral trioxide aggregate and Biodentine: a pilot histological study on humans.
Tirone, F, Salzano, S, Piattelli, A, Perrotti, V, Iezzi, G
Australian dental journal. 2018;(2):231-241
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BACKGROUND The aim of this study was to investigate for the first time the histological response of human periodontium to mineral trioxide aggregate (MTA) and Biodentine. METHODS Six patients scheduled for implant full-arch rehabilitation were randomly assigned to one of the two test groups: MTA or Biodentine treatment. For each patient, two teeth scheduled for strategic extraction were randomly assigned either to the test or to the control treatment. A lateral perforation was drilled on the root and either repaired with MTA/Biodentine or filled with gutta-percha(control). Three months later, the teeth were extracted along with the coronal third of the alveolar bone and a portion of gingival tissue, while performing implant placement, and processed for histological analysis. RESULTS Biodentine resulted in less extrusion into the periodontal environment. All the materials showed good biocompatibility. A new mineralized cementum-like tissue incorporating periodontal fibres was visible in all cases treated with MTA. A small amount of new mineralized tissue was found in two Biodentine cases but not in control cases. Biodentine resulted in less damage to the periodontal ligament. CONCLUSIONS Bioactivity and biocompatibility of MTA were confirmed in human models. Biodentine proved to be biocompatible, but it seems not to induce cementum regeneration.
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Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial.
Bakhtiar, H, Nekoofar, MH, Aminishakib, P, Abedi, F, Naghi Moosavi, F, Esnaashari, E, Azizi, A, Esmailian, S, Ellini, MR, Mesgarzadeh, V, et al
Journal of endodontics. 2017;(11):1786-1791
Abstract
INTRODUCTION Questions exist regarding the efficacy of resin-containing materials such as TheraCal directly applied on the pulp. This study sought to investigate the clinical efficacy of TheraCal as compared with Biodentine and ProRoot mineral trioxide aggregate (MTA) for partial pulpotomy. METHODS In this clinical trial, partial pulpotomy was performed for 27 sound human maxillary and mandibular third molars scheduled for extraction. The teeth were randomly divided into 3 groups (n = 9) and underwent partial pulpotomy with TheraCal, Biodentine, and ProRoot MTA. The teeth were then restored with glass ionomer cement. Clinical and electric pulp tests were performed after 1 and 8 weeks. The teeth were radiographed and extracted at 8 weeks. Histologic sections were prepared and analyzed for pulp inflammation and dentinal bridge formation. Data were analyzed by using one-way analysis of variance. RESULTS Clinical examination showed no sensitivity to heat, cold, or palpation in ProRoot MTA and Biodentine groups. Two patients in TheraCal group (20%) reported significant pain at 1 week. Periapical radiographs showed no periapical pathology, and electric pulp test revealed a normal pulp response with no hypersensitivity. Inflammation was absent with all materials at 8 weeks. Normal pulp organization was seen in 33.33% of the teeth in ProRoot MTA, 11.11% in TheraCal, and 66.67% in Biodentine group (P = .06). Biodentine group showed complete dentinal bridge formation in all teeth, whereas this rate was 11% and 56% in TheraCal and ProRoot MTA groups, respectively (P = .001). CONCLUSIONS Overall, Biodentine and MTA performed better than TheraCal when used as partial pulpotomy agent and presented the best clinical outcomes.
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Arsenic trioxide intravenous infusion combined with transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with pulmonary metastasis: Long-term outcome analysis.
Hu, HT, Yao, QJ, Meng, YL, Li, HL, Zhang, H, Luo, JP, Guo, CY, Geng, X
Journal of gastroenterology and hepatology. 2017;(2):295-300
Abstract
OBJECTIVE To evaluate the safety, clinical efficacy, and long-term outcome of arsenic trioxide (As2 O3 ) intravenous infusion for pulmonary metastases in patients with HCC. MATERIALS AND METHODS Sixty consecutive patients who were diagnosed with advanced hepatocellular carcinoma (HCC) with pulmonary metastasis were randomized 1:1 into the treatment and control groups. Treatment group underwent transcatheter arterial chemoembolization (TACE) for the primary liver tumor and then underwent As2 O3 treatment, whereas control group underwent TACE alone. The treatment group underwent a continuous 5-h intravenous infusion of 10 mg/day As2 O3 . The course of As2 O3 treatment was initiated 3-5 days after TACE (to allow liver and gastrointestinal function to recover) and continued for 14 consecutive days. All patients in the treatment group underwent at least four treatment courses. Response to treatment was evaluated after four treatment courses. RESULT In treatment group, two patients had a complete response (CR), six had a partial response (PR), 10 had stable disease (SD), and 12 had progressive disease. A clinically effective rate (CR + PR) was achieved in 26.7%, and the clinical benefit rate (CR + PR + SD) was 60%. In the control group, no patients had a CR or PR, five had SD, and 25 had progressive disease. The clinically effective rate was 0%, and the clinical benefit rate was 16.7%. The overall 1-year survival was 56.7% in treatment group and 36.7% in control group. The overall 2-year survival was 16.7% in treatment group and 3.3% in control group. CONCLUSION Transcatheter arterial chemoembolization plus an intravenous infusion of As2 O3 effectively controlled pulmonary metastasis and prolonged overall survival in patients with HCC compared with TACE alone.
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Reduction of health care-associated infection indicators by copper oxide-impregnated textiles: Crossover, double-blind controlled study in chronic ventilator-dependent patients.
Marcus, EL, Yosef, H, Borkow, G, Caine, Y, Sasson, A, Moses, AE
American journal of infection control. 2017;(4):401-403
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BACKGROUND Copper oxide has potent wide-spectrum biocidal properties. The purpose of this study is to determine if replacing hospital textiles with copper oxide-impregnated textiles reduces the following health care-associated infection (HAI) indicators: antibiotic treatment initiation events (ATIEs), fever days, and antibiotic usage in hospitalized chronic ventilator-dependent patients. METHODS A 7-month, crossover, double-blind controlled trial including all patients in 2 ventilator-dependent wards in a long-term care hospital. For 3 months (period 1), one ward received copper oxide-impregnated textiles and the other received untreated textiles. After a 1-month washout period of using regular textiles, for 3 months (period 2) the ward that received the treated textiles received the control textiles and vice versa. The personnel were blinded to which were treated or control textiles. There were no differences in infection control measures during the study. RESULTS There were reductions of 29.3% (P = .002), 55.5% (P < .0001), 23.0% (P < .0001), and 27.5% (P < .0001) in the ATIEs, fever days (>37.6°C), days of antibiotic treatment, and antibiotic defined daily dose per 1,000 hospitalization days, respectively, when using the copper oxide-impregnated textiles. CONCLUSIONS Use of copper oxide-impregnated biocidal textiles in a long-term care ward of ventilator-dependent patients was associated with a significant reduction of HAI indicators and antibiotic utilization. Using copper oxide-impregnated biocidal textiles may be an important measure aimed at reducing HAIs in long-term care medical settings.