Comparative Studies of the Structural and Physicochemical Properties of the First Fullerene Derivative FD-C (Fullerenol) and Second Fullerene Derivate SD-C (3HFWC).

In order to maximally reduce the toxicity of fullerenol (the first derivative of C, FD-C), and increase its biomedical efficiency, the second derivative SD-C (3HFWC, Hyper-Harmonized Hydroxylated Fullerene Water Complex) was created. Several different methods were applied in the comparative characterization of FD-C and SD-C with the same OH groups in their core. FD-C as an individual structure was about 1.

Effect of Denture Hygiene Protocols on Patient Satisfaction, Oral Health-Related Quality of Life, and Salivary Parameters: A Randomized Clinical Trial.

Purpose: This randomized controlled trial compared four denture hygiene protocols in terms of patient satisfaction, oral health-related quality of life (OHRQoL), and salivary parameters in complete denture wearers with denture stomatitis.

Material And Methods: For this randomized, double-blind, controlled clinical trial, 108 participants were assigned to soak their dentures in one of the following solutions: (1) 0.25% sodium hypochlorite (positive control), (2) 0.

Effect of local hygiene protocols on denture-related stomatitis, biofilm, microbial load, and odor: A randomized controlled trial.

Statement Of Problem: Denture stomatitis affects complete denture wearers and is frequently treated with antifungals drugs, as well as treating the denture with sodium hypochlorite. Whether the limitations of these treatments can be overcome with local hygiene protocols that do not damage the denture materials or adversely affect the patient is unclear.

Purpose: The purpose of this randomized controlled trial was to evaluate the effect of denture hygiene protocols on complete denture wearers with denture stomatitis.

Efficacy of PerioTabs, a NitrAdine-based gingiva brushing solution, on periodontally affected patients treated with fixed partial dentures: a randomized controlled study.

Objectives: Recent data show that teeth prepared with horizontal finishing lines supporting crowns and fixed partial dentures present more periodontal disorders than untreated control teeth. Several studies have shown that NitrAdine (bonyf) induces a significant reduction of dental biofilm. The aim of this study was to demonstrate that 10-day use of PerioTabs (bonyf), a NitrAdine-based gingiva brushing solution, is effective in treating gingival inflammation of prosthodontic patients.

The safety and efficacy of AphtoFix® mouth ulcer cream in the management of recurrent aphthous stomatitis.

Background: Recurrent Aphthous stomatitis (RAS) is a prevalent ulcerative and painful disorder of the oral cavity with unknown etiology and for which no efficient treatment is currently available. The present study aimed to evaluate the safety and the efficacy of AphtoFix®, a new mouth ulcer cream that was developed to help treat RAS. Prior to launching the product on the market, two initial safety assessment studies were performed.

Alternative methods for the replacement of eye irritation testing.

In the last decades significant regulatory attempts were made to replace, refine and reduce animal testing to assess the risk of consumer products for the human eye. As the original in vivo Draize eye test has been criticized for limited predictivity, costs and ethical issues, several animal-free test methods have been developed to categorize substances according to the global harmonized system (GHS) for eye irritation.This review summarizes the progress of alternative test methods for the assessment of eye irritation.

State-of-the-art of 3D cultures (organs-on-a-chip) in safety testing and pathophysiology.

Integrated approaches using different in vitro methods in combination with bioinformatics can (i) increase the success rate and speed of drug development; (ii) improve the accuracy of toxicological risk assessment; and (iii) increase our understanding of disease. Three-dimensional (3D) cell culture models are important building blocks of this strategy which has emerged during the last years. The majority of these models are organotypic, i.

State of the art on alternative methods to animal testing from an industrial point of view: ready for regulation?

Despite changing attitudes towards animal testing and current legislation to protect experimental animals, the rate of animal experiments seems to have changed little in recent years. On May 15-16, 2013, the In Vitro Testing Industrial Platform (IVTIP) held an open meeting to discuss the state of the art in alternative methods, how companies have, can, and will need to adapt and what drives and hinders regulatory acceptance and use. Several key messages arose from the meeting.

Retrospective analysis of the Draize test for serious eye damage/eye irritation: importance of understanding the in vivo endpoints under UN GHS/EU CLP for the development and evaluation of in vitro test methods.

For more than two decades, scientists have been trying to replace the regulatory in vivo Draize eye test by in vitro methods, but so far only partial replacement has been achieved. In order to better understand the reasons for this, historical in vivo rabbit data were analysed in detail and resampled with the purpose of (1) revealing which of the in vivo endpoints are most important in driving United Nations Globally Harmonized System/European Union Regulation on Classification, Labelling and Packaging (UN GHS/EU CLP) classification for serious eye damage/eye irritation and (2) evaluating the method's within-test variability for proposing acceptable and justifiable target values of sensitivity and specificity for alternative methods and their combinations in testing strategies. Among the Cat 1 chemicals evaluated, 36-65 % (depending on the database) were classified based only on persistence of effects, with the remaining being classified mostly based on severe corneal effects.

Improvement of the Bovine Corneal Opacity and Permeability (BCOP) assay as an in vitro alternative to the Draize rabbit eye irritation test.

Measurement of ocular irritancy is a necessary step in the safety evaluation of both industrial and consumer products. Assessment of the acute eye irritation potential is therefore part of the international regulatory requirements for testing of chemicals. The Bovine Corneal Opacity and Permeability (BCOP) assay is generally accepted as a valid in vitro alternative method to the Draize eye irritation test to detect corrosive and severe eye irritants (category 1), but has not proven sensitive enough to discriminate accurately moderate (category 2A/2B) to mild and non-irritating compounds.

The effect of NitrAdine on the Candida levels of maxillary removable appliances.

Objective: Candida colonization is a consequence of orthodontic treatment and can lead to oral candidosis as a complication of maxillary removable appliance treatment. During orthodontic treatment, it is important to minimize colonization to prevent active infection that could consequently interfere with treatment. Hygiene is the most important factor in managing colonization; in this study, the efficacy of NitrAdine to reduce Candida was tested.

Implementation challenges for designing integrated in vitro testing strategies (ITS) aiming at reducing and replacing animal experimentation.

At the IVTIP (in vitro testing industrial platform) meeting of November 26th 2009 entitled 'Toxicology in the 21st century ('21C')--working our way towards a visionary reality' all delegates endorsed the emerging concept of the '21C' vision as the way forward to enable a thorough, reliable and systematic approach to future toxicity testing without the use of animals. One of the emerging concepts focused on integrating a defined number of tests modelling in vivo-relevant and well-characterised toxicity pathways representing mechanistic endpoints. At this meeting the importance of Integrated Testing Strategies (ITS) as tools towards reduction and eventually replacement of the animals currently used for hazard identification and risk assessment was recognised.

Toxicology in the 21st century--working our way towards a visionary reality.

In November 2009 the In Vitro Testing Industrial Platform (IVTIP) organized a meeting entitled 'Toxicology in the 21st century--working our way towards a visionary reality'. Participating delegates included scientists, key opinion leaders, developers and users of 3Rs-related tests and testing strategies. This paper summarizes the discussions with respect to the conditions required to move the vision towards an applicable reality.

Clinical and antimicrobial efficacy of NitrAdine ™-based disinfecting cleaning tablets in complete denture wearers.

Objective: This study evaluated the efficacy of NitrAdine ™-based disinfecting cleaning tablets for complete denture, in terms of denture biofilm removal and antimicrobial action.

Material And Methods: Forty complete denture wearers (14 men and 26 women) with a mean age of 62.3 ± 9.

Randomized, double-blind, placebo-controlled trial to test the efficacy of nitradine tablets in maxillary removable orthodontic appliance patients.

Objective: to evaluate the efficiency of NitrAdine (MSI Laboratories) tablets in the reduction of oral Candida levels, biofilm formation, and appliance odor in maxillary removable orthodontic appliance wearers.

Method And Materials: seventy children between 11 and 15 years of age undergoing maxillary removable appliance treatment were assigned via a double-blind randomized method to the experimental or placebo arm of the study. One milliliter of unstimulated saliva was collected at the beginning of the experiment and 6 weeks later after treatment of the maxillary removable appliance with NitrAdine tablets.

An evaluation of a cultured human corneal epithelial tissue model for the determination of the ocular irritation potential of pharmaceutical process materials.

Irritation and other forms of local toxicity following contact with eyes is a potentially serious problem arising from occupational exposure to chemicals. Traditionally, evaluation of the irritant potential of novel chemicals has relied on the use of in vivo studies with rabbits. Concerns about the predictive potential of in vivo methods for human hazard and demand for economical and rapid screening of chemicals has stimulated a great deal of work to investigate in vitro alternatives for evaluating ocular irritation potential.

Assessment of the skin irritation potential of chemicals by using the SkinEthic reconstructed human epidermal model and the common skin irritation protocol evaluated in the ECVAM skin irritation validation study.

Currently, two reconstructed human skin models, EpiDerm and EPISKIN are being evaluated in an ECVAM skin irritation validation study. A common skin irritation protocol has been developed, differing only in minor technical details for the two models. A small-scale study, applying this common skin irritation protocol to the SkinEthic reconstructed human epidermis (RHE), was performed at ZEBET at the BfR, Berlin, Germany, to consider whether this protocol could be successfully transferred to another epidermal model.

Assessment of the human epidermis model SkinEthic RHE for in vitro skin corrosion testing of chemicals according to new OECD TG 431.

Based on two successfully completed ECVAM validation studies for in vitro skin corrosion testing of chemicals, the National Co-ordinators of OECD Test Guideline Programme endorsed in 2002 two new test guidelines: TG 430 'Transcutaneous Electrical Resistance assay' and TG 431 'Human Skin Model Test'. To allow all suitable in vitro human reconstructed (dermal or epidermal) models to be used for skin corrosion testing, the OECD TG 431 defines general and functional conditions that the model must meet before it will be routinely used for skin corrosion testing. In addition, the guideline requires correct prediction of 12 reference chemicals and assessment of intra- and inter-laboratory variability.

Differential expression of extracellular matrix metalloproteinase inducer (CD147) in normal and ulcerated corneas: role in epithelio-stromal interactions and matrix metalloproteinase induction.

Extracellular matrix metalloproteinase inducer (EMMPRIN) was originally identified on the tumor cell surface as an inducer of matrix metalloproteinase (MMP) production in neighboring fibroblasts. Here we demonstrate a role for EMMPRIN in MMP induction during corneal wound healing. MMP and EMMPRIN expression was analyzed in normal and ulcerated human corneas, as well as in corneal epithelial and stromal cells in culture using confocal microscopy, zymography, immunoblots, and real-time polymerase chain reaction.

Transcriptional profiling of epidermal keratinocytes: comparison of genes expressed in skin, cultured keratinocytes, and reconstituted epidermis, using large DNA microarrays.

Epidermal keratinocytes are complex cells that create a unique three-dimensional (3-D) structure, differentiate through a multistage process, and respond to extracellular stimuli from nearby cells. Consequently, keratinocytes express many genes, i.e.