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Abstract Background Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) present serious reproductive health risks and management challenges, with poor control attributed to survival of treatment-resistant biofilm communities. Boric acid is used in various regimens for non-albicans VVC and recurrent BV. We investigated safety and efficacy of a novel boric acid–based vaginal anti-infective with enhanced antibiofilm activity (TOL-463) in treating BV and VVC. Methods In this phase 2 randomized, investigator-blinded trial conducted at 2 sexual health clinics, women with BV or VVC were randomly assigned (1:1) to 7 nights of TOL-463 vaginal gel or insert. The primary test of cure (TOC) was clinical cure at day 9–12; safety was assessed at TOC and day 21–30. Results One hundred six participants (53 with BV, 36 VVC, 17 both) were enrolled; most were African American (69%). Clinical cure rate of BV at TOC was 59% (95% confidence interval [CI], 41%–75%) for TOL-463 insert and 50% (95% CI, 31%–69%) for TOL-463 gel, and for VVC, 92% (95% CI, 67%–99%) for TOL-463 insert and 81% (95% CI, 57%–93%) for TOL-463 gel. Both products were safe and well tolerated with no secondary cases of VVC; vulvovaginal burning was the most common adverse event (9.6%). Conclusions TOL-463, especially in vaginal insert form, is effective and safe in treating BV and VVC. Future studies should assess the potential role of TOL-463 as a biofilm disrupter in enhancing likelihood of cure relative to approved therapies, reducing recurrence rates, and combined with traditional antimicrobials. Clinical Trials Registration NCT02866227. TOL-463 vaginal gel or insert, a boric acid–based anti-infective with enhanced antibiofilm activity, was effective and safe in treating Bacterial Vaginosis and Vulvovaginal Candidiasis, with the vaginal insert demonstrating higher efficacy for both conditions.

Dental plaque provides a proper environment for the growth and activity of bacteria responsible for periodontal diseases and caries. As a result, it should be removed by individuals to prevent periodontal diseases and caries. There are different mechanical and chemical plaque control methods. In one study is shown that dental plaque removal efficacy of dentifrice containing Ethylenediaminetetraaceticacid(EDTA)/Methylsulfonylmethane(MSM) was nearly five times that of commercially available fluoride toothpaste. In another study, authors found that xylitol-containing chewing gums caused a marked reduction in the count of Streptococcus Mutans compared to conventional ones. This difference was highly prominent in individuals with poor oral hygiene. In this study we assessed the synergic effects of Xylitol, EDTA and MSM in a chewing gum in comparison with chlorhexidine mouthwash. This study was a crossover, randomized clinical trial. Twenty-four patients were divided in two groups randomly. At the baseline scaling and root planing was done for each patient. Group1 used chlorhexidine mouthwash twice a day. Group2 used novel chewing gum for 15 min twice a day. After 14 days, for every patient O’leary plaque index, gingival index and sulcus bleeding index were reevaluated and recorded. Professional brushing was done for patients. 14 days were considered as wash-out period. After that, method of plaque control of groups was changed. After 14 days, all patients were reevaluated and recorded and were compared with previous data. Samples in 2 groups had no significant difference in age and sex. Paired sample t test revealed that there were significant differences between first and second period for O’leary plaque index, gingival index and sulcus bleeding index in Group1 ( P  < 0.05). But in Group2 there were no differences between first and second period for all indexes. Also independent sample t test showed that there were no significant differences between baseline, after first treatment and after second one for all indexes in both groups ( P  > 0.05). According to regression model results, type of treatment had no effect on mean of all indexes. According to our findings which showed the similar efficiency of novel chewing gum and chlorhexidine mouthwash in improving and reducing plaque and gingival indexes, we can conclude that novel chewing gum can be introduced as an effective, cheap and accessible tool for dental plaque control.

ObjectiveIron-containing micronutrient powders (MNPs) reduce anaemia in African infants, but the current high iron dose (12.5 mg/day) may decrease gut Bifidobacteriaceae and Lactobacillaceae, and increase enteropathogens, diarrhoea and respiratory tract infections (RTIs). We evaluated the efficacy and safety of a new MNP formula with prebiotic galacto-oligosaccharides (GOS) combined with a low dose (5 mg/day) of highly bioavailable iron.DesignIn a 4-month, controlled, double-blind trial, we randomised Kenyan infants aged 6.5–9.5 months (n=155) to receive daily (1) a MNP without iron (control); (2) the identical MNP but with 5 mg iron (2.5 mg as sodium iron ethylenediaminetetraacetate and 2.5 mg as ferrous fumarate) (Fe group); or (3) the identical MNP as the Fe group but with 7.5 g GOS (FeGOS group).ResultsAnaemia decreased by ≈50% in the Fe and FeGOS groups (p<0.001). Compared with the control or FeGOS group, in the Fe group there were (1) lower abundances of Bifidobacterium and Lactobacillus and higher abundances of Clostridiales (p<0.01); (2) higher abundances of virulence and toxin genes (VTGs) of pathogens (p<0.01); (3) higher plasma intestinal fatty acid-binding protein (a biomarker of enterocyte damage) (p<0.05); and (4) a higher incidence of treated RTIs (p<0.05). In contrast, there were no significant differences in these variables comparing the control and FeGOS groups, with the exception that the abundance of VTGs of all pathogens was significantly lower in the FeGOS group compared with the control and Fe groups (p<0.01).ConclusionA MNP containing a low dose of highly bioavailable iron reduces anaemia, and the addition of GOS mitigates most of the adverse effects of iron on the gut microbiome and morbidity in African infants.Trial registration numberNCT02118402.

The global contamination of water resources with inorganic and organic micropollutants, such as metals and pharmaceuticals, poses a critical threat to the environment and human health. Herein, we report on a bio-derived chitosan-EDTA-β-cyclodextrin (CS-ED-CD) trifunctional adsorbent fabricated via a facile and green one-pot synthesis method using EDTA as a cross-linker, for the adsorption of toxic metals and organic micropollutants from wastewater. In this system, chitosan chain is considered as the backbone, and the immobilized cyclodextrin cavities capture the organic compounds via host-guest inclusion complexation, while EDTA-groups complex metals. The thoroughly characterized CS-ED-CD was employed for batch adsorption experiments. The adsorbent displayed a monolayer adsorption capacity of 0.803, 1.258 mmol g −1 for Pb(II) and Cd(II) respectively, while a heterogeneous sorption capacity of 0.177, 0.142, 0.203, 0.149 mmol g −1 for bisphenol-S, ciprofloxacin, procaine, and imipramine, respectively. The adsorption mechanism was verified by FT-IR and elemental mapping. Importantly, the adsorbent perform is effective in the simultaneous removal of metals and organic pollutants at environmentally relevant concentrations. All these findings demonstrate the promise of CS-ED-CD for practical applications in the treatment of micropollutants. This work adds a new insight to design and preparation of efficient trifunctional adsorbents from sustainable materials for water purification.

Objectives Effective disinfection of the root canals is the cornerstone of successful endodontic treatment. Diminishing the microbial load within the root canal system is crucial for healing in endodontically treated teeth. The aim of this study was to evaluate the effect of 2780 nm Er,Cr:YSGG and 940 nm diode lasers on the eradication of microorganisms from single-rooted teeth with asymptomatic apical periodontitis. Materials and Methods Thirty participants conforming to the inclusion criteria were randomly divided into 3 groups according to the disinfection protocol used; Conventional group: 2.5% Sodium Hypochlorite (NaOCl) and 17% EDTA solution NaOCl/EDTA, Dual laser group: 2780 nm Erbium, chromium: yttrium scandium-gallium-garnet (Er,Cr:YSGG) laser and 940 nm diode laser Er,CrYSGG/Diode, and Combined group: 17% EDTA and 940 nm diode laser EDTA/Diode. Bacterial samples were collected before and after intervention. The collected data were statistically analyzed using Friedman’s test and Kruskal–Wallis test ( P  ≤  0.05 ). Results The results of the study showed that both dual laser Er,CrYSGG/Diode and combined laser EDTA/Diode groups showed significantly less mean Log10 CFU/ml of aerobic and anaerobic bacterial counts than the conventional NaOCl/EDTA group. Conclusions In this study we evaluated in vivo the bactericidal efficacy of three disinfection protocols for endodontic treatment of single-rooted teeth with apical periodontitis. The results indicated that both dual laser Er,CrYSGG/Diode and combined laser EDTA/Diode groups provide superior bactericidal effect compared to the conventional NaOCl/EDTA group. Clinical relevance The integration of lasers into root canal disinfection protocols has demonstrated significant bacterial reduction which might promote healing and long-term success.

Fe fortification of wheat flour was proposed in Haiti to combat Fe deficiency, but Fe bioavailability from fortificants has never been investigated in Haitian women or preschool children, two key target groups. We aimed to investigate the bioavailability of ferrous fumarate (FeFum), NaFeEDTA and their combination from fortified wheat flour. We recruited twenty-two healthy mother–child pairs in Port au Prince, Haiti, for an Fe-absorption study. We administered stable Fe isotopes as FeFum or NaFeEDTA individually in low-extraction wheat flour bread rolls consumed by all participants in a randomised, cross-over design. In a final, identical meal, consumed only by the women, FeFum+NaFeEDTA was administered. We measured Fe absorption by using erythrocyte incorporation of stable isotopes 14 d after consumption of each meal, and determined Fe status, inflammatory markers and Helicobacter pylori infection. Fe absorption (geometric mean was 9·24 (95 % CI 6·35, 13·44) and 9·26 (95 % CI 7·00, 12·31) from FeFum and 13·06 (95 % CI 9·23, 19·10) and 12·99 (95 % CI 9·18, 18·39) from NaFeEDTA in mothers and children, respectively (P<0·05 between compounds). Fe absorption from FeFum+NaFeEDTA was 11·09 (95 % CI 7·45, 17·34) and did not differ from the other two meals. H. pylori infection did not influence Fe absorption in children. In conclusion, in Haitian women and children, Fe absorption from NaFeEDTA was 40 % higher than from FeFum, and the combination FeFum+NaFeEDTA did not significantly increase Fe absorption compared with FeFum alone. In the context of Haiti, where the high costs of NaFeEDTA may not be affordable, the use of FeFum at 60 mg Fe/kg flour may be a preferable, cost-effective fortification strategy.

Purpose Gallium-68 (Ga-68)-labeled tracers for imaging expression of the prostate-specific membrane antigen (PSMA) such as the [ 68 Ga]Ga-PSMA-HBED-CC have already demonstrated high potential for the detection of recurrent prostate cancer. However, compared to Ga-68, a labeling with fluorine-18 (F-18) would offer advantages with respect to availability, production amount, and image resolution. [ 18 F]DCFPyL is a promising F-18-labeled candidate for PSMA-positron emission tomography (PET) imaging that has been recently introduced. In the current study, we aimed to compare [ 68 Ga]Ga-PSMA-HBED-CC and [ 18 F]DCFPyL for clinical use in biochemically relapsed prostate cancer. Procedures In 14 selected patients with PSA relapse of prostate cancer, [ 18 F]DCFPyL PET/X-ray computed tomography (CT) was performed in addition to [ 68 Ga]Ga-PSMA-HBED-CC PET/CT. A systematic comparison was carried out between results obtained with both tracers with regard to the number of detected PSMA-positive lesions, the standardized uptake value (SUV) max and the lesion to background ratios. Results All suspicious lesions identified by [ 68 Ga]Ga-PSMA-HBED-CC were also detected with [ 18 F]DCFPyL. In three patients, additional lesions were observed using [ 18 F]DCFPyL PET/CT. The mean SUV max in the concordant [ 18 F]DCFPyL PSMA-positive lesions was significantly higher as compared to [ 68 Ga]Ga-PSMA-HBED-CC (14.5 vs. 12.2, p  = 0.028, n  = 15). The mean tumor to background ratios ( n  = 15) were significantly higher for [ 18 F]DCFPyL compared to [ 68 Ga]Ga-PSMA-HBED-CC using kidney, spleen, or parotid as reference organs ( p  = 0.006, p  = 0.002, p  = 0.008), but no significant differences were found using the liver ( p  = 0.167) or the mediastinum ( p  = 0.363) as reference organs. Conclusion [ 18 F]DCFPyL PET/CT provided a high image quality and visualized small prostate lesions with excellent sensitivity. [ 18 F]DCFPyL represents a highly promising alternative to [ 68 Ga]Ga-PSMA-HBED-CC for PSMA-PET/CT imaging in relapsed prostate cancer.

Cryopreservation is the gold standard for preserving high molecular weight (HMW) DNA (>10 kb) in tissue samples. However, frozen tissues are typically thawed either before or during DNA extraction, which can lead to substantial DNA degradation. In this study, we thawed the previously frozen tissues of 10 marine species (five fishes and five invertebrates) in the preservatives EDTA (250 mM, pH 10) or ethanol (EtOH, 95%) and maintained them in their respective preservatives overnight at 4°C before DNA extraction. We then compared the recovery of HMW DNA in these extracts to extracts prepared directly from frozen tissues. To evaluate the effect of these treatments on HMW DNA recovery, we determined the percentage of high molecular weight DNA (%HMW) and yield of HMW DNA normalized by tissue weight (nY) in each DNA extract. The average %HMW values for eight of the 10 species and the average nY values for five of the 10 species were significantly higher in extracts from EDTA-treated tissues compared to extracts from untreated frozen tissues. For all 10 species, we observed no significant decreases in average %HMW or nY values in extracts of EDTA-thawed tissues compared to those extracted directly from frozen tissues. In contrast, EtOH treatment did not significantly improve the average %HMW or nY values in extracts from tissues of nine of the 10 species when compared to extracts prepared directly from frozen tissues. Therefore, investigators may consider EDTA treatment as a simple method for improving HMW DNA recovery from frozen tissues.

Intravenous edetate disodium-based infusions reduced cardiovascular events in a prior clinical trial. The Trial to Assess Chelation Therapy 2 (TACT2) will replicate the initial study design. TACT2 is an NIH-sponsored, randomized, 2x2 factorial, double masked, placebo-controlled, multicenter clinical trial testing 40 weekly infusions of a multi-component edetate disodium (disodium ethylenediamine tetra-acetic acid, or Na2EDTA)-based chelation solution and twice daily oral, high-dose multivitamin and mineral supplements in patients with diabetes and a prior myocardial infarction (MI). TACT2 completed enrollment of 1000 subjects in December 2020, and infusions in December 2021. Subjects are followed for 2.5 to 5 years. The primary endpoint is time to first occurrence of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. The trial has >;85% power to detect a 30% relative reduction in the primary endpoint. TACT2 also includes a Trace Metals and Biorepository Core Lab, to test whether benefits of treatment, if present, are due to chelation of lead and cadmium from patients. Design features of TACT2 were chosen to replicate selected features of the first TACT, which demonstrated a significant reduction in cardiovascular outcomes in the EDTA chelation arm compared with placebo among patients with a prior MI, with the largest effect in patients with diabetes. Results are expected in 2024. TACT2 may provide definitive evidence of the benefit of edetate disodiumbased chelation on cardiovascular outcomes, as well as the clinical importance of longitudinal changes in toxic metal levels of participants.

This study aimed to compare the effectiveness of initial irrigation with sodium hypochlorite (NaOCl) and final irrigation with QMix, 40% citric acid, and 17% ethylenediaminetetraacetic acid (EDTA) on smear layer removal and dentin erosion. Forty extracted human mandibular premolar teeth were randomly divided into four groups (n = 10) according to the type of final irrigants used: 17% EDTA, QMix, citric acid, and control (normal saline). Canals were mechanically prepared using ProTaper Next instruments to an apical size of X3. Subsequently, the roots were sectioned in a buccolingual direction. Scanning electron microscopy (SEM) was used to assess the presence of the smear layer and the amount of dentin erosion in the coronal, middle, and apical thirds of the root canals. In regards to smear layer removal, there was a significant difference between the control group and the other tested groups. Moreover, it was significantly higher in the coronal and middle thirds than in the apical third. However, there were no significant differences between the groups of EDTA, QMix, and citric acid. Concerning dentin erosion, citric acid produced significantly more dentin erosion than the other tested groups. Final irrigation with solutions had a higher ability to remove the smear layer in the coronal and middle thirds compared to the apical third. Of all the solutions tested, 40% citric acid had the most pronounced impact on dentin erosion, followed by 17% EDTA and QMix.