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Influence of the long-term use of oral hygiene products containing stannous ions on the salivary microbiome - a randomized controlled trial.
Anderson, AC, Al-Ahmad, A, Schlueter, N, Frese, C, Hellwig, E, Binder, N
Scientific reports. 2020;(1):9546
Abstract
Oral hygiene products containing tin are suitable to prevent erosive tooth wear, yet effects on the oral microbiota are not known yet. Therefore, this study determined the salivary microbiome of 16 participants using products with stannous ions for three years (TG) compared with a control group (CG) to assess their influence on the microbiota. Participants were included in a randomized controlled clinical trial (RCT) with biannual visits. Illumina Miseq sequencing revealed as most abundant genera: Streptococcus (TG 14.3%; CG 13.0%), Veillonella (TG 11.3%; CG 10.9%), Prevotella (TG 7.0%; CG 9.8%), Haemophilus (TG 6.6%; CG 7.2%), Porphyromonas (TG 5.9%, CG 5.1%), Leptotrichia (TG 5.8%; CG 4.9%), Actinomyces (TG 4.0%; CG 4.6%) and Neisseria (TG 5.4%; CG 4.2%). Beta-Diversity was not significantly different between groups at both time points, although significant differences between groups were found for certain taxa after three years. The genus Prevotella was found in higher abundance in CG whereas Neisseria and Granulicatella, health-associated taxa, were found more abundantly in TG. Salivary microbiota after three years reflected a composition associated with oral health, hence continual use as a preventive measure for dental erosion can be considered safe and benefitting oral health for patients with a high risk of erosion.
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Randomized exploratory study to measure ion release from calcium sodium phosphosilicate-containing dentifrice.
Burnett, GR, Morrison, J, Whitworth, D, Hughes, AJ, Nehme, M, Sanyal, S, Brotherhood, AJ, Hall, PJ
European journal of oral sciences. 2018;(5):382-389
Abstract
This exploratory study investigated salivary concentrations of silicon, calcium, sodium, and phosphorous over a 60-min time period following the use of a calcium sodium phosphosilicate (CSPS)-containing dentifrice. Participants brushed with a dentifrice containing 5% (w/w) or 0% (w/w) CSPS or swilled with a slurry containing 5% (w/w) CSPS/glycerol. Saliva samples were collected before, and 2, 5, 15, and 60 min after, product use and were analysed using inductively coupled plasma optical emission spectroscopy. Intra-oral pH measurements were also taken. Primary analysis was of centrifuged saliva supernatant containing only dissolved material. At most time points, the CSPS-containing dentifrice and slurry generated significantly more salivary silicon than the dentifrice containing 0% CSPS. At 2-15 min after brushing there was significantly more salivary calcium after use of the CSPS-containing dentifrice and slurry, compared with the 0% CSPS dentifrice; a significant reduction, from baseline, in salivary calcium after use of dentifrice containing 0% CSPS; and an increase in salivary sodium after use of dentifrices containing either 5% or 0% CSPS, but no differences between them. Salivary phosphorous concentration decreased significantly with all treatments 2-5 min after use. There were no significant between-treatment differences in intra-oral pH. Products were generally well tolerated. This study establishes that it is possible to measure changes in salivary ionic composition derived through oral retention of CSPS, delivered via a dentifrice.
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Randomized phase II trial of hypofractionated proton versus carbon ion radiation therapy in patients with sacrococcygeal chordoma-the ISAC trial protocol.
Uhl, M, Edler, L, Jensen, AD, Habl, G, Oelmann, J, Röder, F, Jäckel, O, Debus, J, Herfarth, K
Radiation oncology (London, England). 2014;:100
Abstract
BACKGROUND Chordomas are relatively rare lesions of the bones. About 30% occur in the sacrococcygeal region. Surgical resection is still the standard treatment. Due to the size, proximity to neurovascular structures and the complex anatomy of the pelvis, a complete resection with adequate safety margin is difficult to perform. A radical resection with safety margins often leads to the loss of bladder and rectal function as well as motoric/sensoric dysfunction. The recurrence rate after surgery alone is comparatively high, such that adjuvant radiation therapy is very important for improving local control rates. Proton therapy is still the international standard in the treatment of chordomas. High-LET beams such as carbon ions theoretically offer biologic advantages in slow-growing tumors. Data of a Japanese study of patients with unresectable sacral chordoma showed comparable high control rates after hypofractionated carbon ion therapy only. METHODS AND DESIGN This clinical study is a prospective randomized, monocentric phase II trial. Patients with histologically confirmed sacrococcygeal chordoma will be randomized to either proton or carbon ion radiation therapy stratified regarding the clinical target volume. Target volume delineation will be carried out based on CT and MRI data. In each arm the PTV will receive 64 GyE in 16 fractions. The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points. DISCUSSION The aim of this study is to confirm the toxicity results of the Japanese data in raster scan technique and to compare it with the toxicity analysis of proton therapy given in the same fractionation. Using this data, a further randomized phase III trial is planned, comparing hypofractionated proton and carbon ion irradiation. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01811394.
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Metal hypersensitivity and metal ion levels in patients with coated or uncoated total knee arthroplasty: a randomised controlled study.
Lützner, J, Hartmann, A, Dinnebier, G, Spornraft-Ragaller, P, Hamann, C, Kirschner, S
International orthopaedics. 2013;(10):1925-31
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Abstract
PURPOSE Metal ion release by orthopaedic implants may cause local and systemic effects and induce hypersensitivity reactions. Coated implants have been developed to prevent or reduce these effects. This study was initiated to investigate the safety of a novel coating for total knee arthroplasty (TKA) implants. METHODS A total of 120 patients undergoing primary TKA with no history of hypersensitivity and no other metal implant were randomised to receive either a coated or uncoated implant. Chromium (Cr), cobalt (Co), molybdenum (Mb) and nickel (Ni) hypersensitivity patch testing and plasma ion concentrations were evaluated pre-operatively and one year post-operatively. RESULTS At the one year follow-up both groups demonstrated significant improvement in knee function and quality of life. One new weakly positive reaction to Co in the TKA group with coated implant and two doubtful skin reactions to Ni (one in each group) were noted. Even with sensitisation to implant materials no skin reactions were observed. Plasma metal ion concentrations did not increase and were not elevated at the one year follow-up in either group. CONCLUSIONS Sensitisation after TKA was rare and had no influence on clinical results. TKA with coated implant and standard TKA demonstrated no plasma metal ion elevation.
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Seric ion level and its relationship with the symptoms of premenstrual syndrome in young women.
dos Santos, LA, de Azeredo, VB, Eloy Chaves Barbosa, D, Augusta de Sá, S
Nutricion hospitalaria. 2013;(6):2194-200
Abstract
UNLABELLED The aim of the study was to evaluate the seric ions level and its relationship with Premenstrual Syndrome (PMS) symptoms in young women. METHOD Ninety-three volunteers were monitored for three months. The nutritional status evaluation was based on BMI. Three "maps of daily symptoms" were used to investigate the frequency of the SPM symptoms. The biochemical evaluation was done in the first month in the luteal phase. The levels of sodium, potassium, calcium, magnesium were determined by colorimetric methods. The hemoglobin and hematocrit concentration were determined by conventional methods. RESULTS The symptoms like anxiety (1,13; 0,81; 0,66), edema (0,99; 0,51; e 0,22), depression (0,58; 0,36; 0,20) and mastalgia (0,56; 0,35; 0,09) were the most evident in the menstrual than luteal and follicular phase. A small number of volunteers presented hypocalemia (1,4%), hyponatremia (4,22%) and hypernatremia (7,04%). However, the higher number of the volunteers presented lower calcium level (83,09%). The frequency of anemic women was high (24%). Significant associations (P < 0.05) were observed between the anxiety symptom and sodium (r = 0,2630); and magnesium and depression (r = 0,2508) and nauseas (r = 2882). CONCLUSIONS The anemia and hypocalcemia is a important nutritional problem. The regulation of the calcium serum level seems to be affected in the luteal phase of the menstrual cycle and the sodium and magnesium ions influence some psychological (anxiety and depression) and gastrointestinal (nausea and constipation) symptoms.
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Tolevamer, a novel nonantibiotic polymer, compared with vancomycin in the treatment of mild to moderately severe Clostridium difficile-associated diarrhea.
Louie, TJ, Peppe, J, Watt, CK, Johnson, D, Mohammed, R, Dow, G, Weiss, K, Simon, S, John, JF, Garber, G, et al
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2006;(4):411-20
Abstract
BACKGROUND Current antibiotic therapies for Clostridium difficile-associated diarrhea have limitations, including progression to severe disease, recurrent C. difficile-associated diarrhea, and selection for nosocomial pathogens. Tolevamer, a soluble, high-molecular weight, anionic polymer that binds C. difficile toxins A and B is a unique nonantibiotic treatment option. METHODS In this 3-arm, multicenter, randomized, double-blind, active-controlled, parallel-design phase II study, patients with mild to moderately severe C. difficile-associated diarrhea were randomized to receive 3 g of tolevamer per day (n = 97), 6 g of tolevamer per day (n = 95), or 500 mg of vancomycin per day (n = 97). The primary efficacy parameter was time to resolution of diarrhea, defined as the first day of 2 consecutive days when the patient had hard or formed stools (any number) or < or = 2 stools of loose or watery consistency. RESULTS In the per-protocol study population, resolution of diarrhea was achieved in 48 (67%) of 72 patients receiving 3 g of tolevamer per day (median time to resolution of diarrhea, 4.0 days; 95% confidence interval, 2.0-6.0 days), in 58 (83%) of 70 patients receiving 6 g of tolevamer per day (median time to resolution of diarrhea, 2.5 days; 95% confidence interval, 2.0-3.0 days), and in 73 (91%) of 80 patients receiving vancomycin (median time to resolution of diarrhea, 2.0 days; 95% confidence interval, 1.0-3.0 days). Tolevamer administered at a dosage of 6 g per day was found to be noninferior to vancomycin administered at a dosage of 500 mg per day with regard to time to resolution of diarrhea (P = .02) and was associated with a trend toward a lower recurrence rate. Tolevamer was well tolerated but was associated with an increased risk of hypokalemia. CONCLUSIONS Tolevamer, a novel polystyrene binder of C. difficile toxins A and B, effectively treats mild to moderate C. difficile diarrhea and merits further clinical development.