In Vitro Biocompatibility of Several Children's Toothpastes on Human Gingival Fibroblasts.

The European Academy of Paediatric Dentistry has recommended fluoride toothpastes from the eruption of the first teeth in children. Toothpastes stay in the mouth in contact with human gingival fibroblasts (hGFs) for a long time. Thus, the objective of this study was to compare the cytotoxicity of five different commonly used children's toothpastes: Oral B Kids +3 (Procter & Gamble, Alicante, Spain), Fluor Kin Calcium (Kin, Madrid, Spain), PHB Junior (PHB, Barcelona, Spain), Colgate +3 (Colgate Palmolive, Madrid, Spain) and Vitis Kids (Dentaid, Valencia, Spain) on hGFs. The children's toothpastes were exposed to hGFs at different concentrations (1:1, 1:2, 1:4). Afterwards, several tests were performed: MTT assays, cell cycle analyses, cell cytoskeleton staining assays, apoptosis/necrosis assays, and ICP-MS and ion chromatography. Oral B displayed the lowest cytotoxicity and was the toothpaste with the highest fluoride ion release; meanwhile, the other toothpastes were cytotoxic (*** p < 0.0001); Fluor Kin being the one with the lowest fluoride ion release. Among all the toothpastes analyzed, Oral B exhibited the best results in vitro in terms of biocompatibility. Future evaluations, both in vitro and in vivo, are required to confirm the biocompatibility of sodium lauryl sarcosinate and sodium lauryl sulfate containing toothpastes.

Cytotoxic effects of different detergent containing children's toothpastes on human gingival epithelial cells.

BACKGROUND: This study aimed to evaluate possible cytotoxic effects to gingival epithelial cells exposed to children toothpastes containing different detergent. METHODS: Tissues required for the isolation of human gingival epithelial cells were obtained by biopsy during the extraction of the impacted third molar tooth. Toothpaste solutions of different concentrations were prepared from five different children's toothpastes with different detergent contents. Isolated gingival epithelial cells were stimulated with experimental groups consisting of toothpaste solutions (Colgate, Sensodyne, Splat, Nenedent, Perlodent) at different concentrations and a control group consisting of complete Dulbecco's modified eagle medium. After the experiments, cell viability was evaluated using flow cytometry. 2 Way ANOVA was used to see the interaction effect of the main effects of toothpaste solution and concentration factors. Pairwise comparisons were made by Tukey post hoc tests. In the study, the significance level was taken as 0.05. RESULTS: As a result of the analysis, it was seen that the toothpaste solution and concentration factors and the interactions of these 2 factors were effective on the viable, early apoptotic, late apoptotic and necrotic cell rates. The statistically highest live cell ratios were detected in Splat's toothpaste solutions (90.14% at 0.4% concentration) after the control group (90.82%) and the group with the lowest viability values was determined in Colgate group (75.74% at 0.4% concentration) (p < 0.05). CONCLUSIONS: According to the results of the study, it was observed that toothpastes containing SLS affected the viability of cells more negatively than toothpastes with other detergent contents.

Toxicity and effect of whitening toothpastes on enamel surface.

This in vitro study evaluated the biocompatibility and abrasivity of whitening and conventional toothpastes. Samples of conventional (non-whitening) - Edel White Infant (EWI) - and whitening toothpastes - Edel White Whitening (EWW), Edel White CAREFORTE (EWC), Colgate Total 12 Ò Professional (C), and Oral-B Whitening (OB) - were dissolved in culture medium (0.2 g sample weight per mL). Human gingival fibroblasts (hGF) were placed in contact with different dilutions of culture media that had been previously exposed to these toothpastes. Cytotoxicity was then assessed using the methyl tetrazolium test (MTT) and the cell survival rate was determined. Genotoxicity was assessed by the micronucleus test (MNT) and the number of micronuclei was determined before and after exposure to the toothpaste solutions. The enamel surface roughness was evaluated in specimens of bovine teeth (n = 10 per group) before and after 10,000 brushing cycles, using the investigated toothpastes. The results were statistically analyzed using the Mann-Whitney U test and two-way ANOVA (p < 0.05). According to the MTT assay, EWW and OB presented significant cytotoxicity (p < 0.01), but no genotoxic (MNT) effects (p > 0.05). C toothpaste was statistically significantly abrasive to the enamel surface (p < 0.01). The findings of this study may be helpful for individualized selection of commercial toothpastes, as some whitening toothpastes present significant cytotoxicity and conventional toothpaste cause significant surface changes.

Toxicity and effect of whitening toothpastes on enamel surface

Abstract This in vitro study evaluated the biocompatibility and abrasivity of whitening and conventional toothpastes. Samples of conventional (non-whitening) - Edel White Infant (EWI) - and whitening toothpastes - Edel White Whitening (EWW), Edel White CAREFORTE (EWC), Colgate Total 12 Ò Professional (C), and Oral-B Whitening (OB) - were dissolved in culture medium (0.2 g sample weight per mL). Human gingival fibroblasts (hGF) were placed in contact with different dilutions of culture media that had been previously exposed to these toothpastes. Cytotoxicity was then assessed using the methyl tetrazolium test (MTT) and the cell survival rate was determined. Genotoxicity was assessed by the micronucleus test (MNT) and the number of micronuclei was determined before and after exposure to the toothpaste solutions. The enamel surface roughness was evaluated in specimens of bovine teeth (n = 10 per group) before and after 10,000 brushing cycles, using the investigated toothpastes. The results were statistically analyzed using the Mann-Whitney U test and two-way ANOVA (p < 0.05). According to the MTT assay, EWW and OB presented significant cytotoxicity (p < 0.01), but no genotoxic (MNT) effects (p > 0.05). C toothpaste was statistically significantly abrasive to the enamel surface (p < 0.01). The findings of this study may be helpful for individualized selection of commercial toothpastes, as some whitening toothpastes present significant cytotoxicity and conventional toothpaste cause significant surface changes.

Ventajas y riesgos del uso de pastas dentales con nanotecnologías / Advantages and hazzards of the use of nanotechnology in toothpastes

El presente artículo de actualización analiza las ventajas y riesgos del uso de nanopartículas en pastas dentales. La nanotecnología puede mejorar sus propiedades ayudando al proceso de remineralización del diente, controlar el crecimiento bacteriano o proporcionar minerales para mejorar el control del pH. Con este fin se han agregado: nanohidroxiapatita, nanocalcio, fosfato de calcio, trimetafosfato de sodio, nanopartículas de plata, quitosán, entre otras. Por otro lado, se han descripto algunos efectos nocivos de estas nanotecnologías, lo que nos motiva a intensificar su estudio. CONCLUSIONES: La nano-odontología ha otorgado nuevas herramientas para la atención preventiva de la salud. La toxicidad oral para los nanodentífricos es baja, pero algunos pueden llegar al intestino, y a través de él a la circulación sanguínea y causar disturbios sistémicos. Es necesario profundizar las investigaciones en estos materiales, a fin de mejorar sus efectos beneficiosos, e identificar y eliminar sus riesgos para la salud. (AU)

The present update article analyzes advantages and risks of nanoparticles in relation to toothpastes. Nanotechnology can improve its properties by helping to remineralize the tooth, control bacterial growth or provide minerals to optimize pH control. For this purpose, anohydroxyapatite, nanocalcium, calcium phosphate, sodium trimetaphosphate, silver nanoparticles, chitosan, among others have been added. On the other hand, some harmful effects of these nanotechnologies have been described, which motivates us to intensify their study. CONCLUSIONS: Nano-dentistry has provided new tools for preventive health care. The oral toxicity for nanodentífricos is low, but some can reach the intestine, and through it to the blood circulation and cause systemic disturbances. It is necessary to deepen the investigations in these materials, in order to improve their beneficial effects, and identify and eliminate their health risks.

Titanium Dioxide in Toothpaste Causing Yellow Nail Syndrome.

Yellow nail syndrome (YNS) is an uncommon disorder, the classic triad of which consists of yellow nails, lymphedema, and respiratory symptoms. Few pediatric cases have been reported. We report a 9-year-old girl with yellowish nail discoloration for 1 year accompanied by respiratory symptoms, including chronic cough, recurrent pneumonia, bronchiectasis, and chronic sinusitis. The patient was diagnosed with YNS. Knowing that a relationship between YNS and titanium has been reported, we collected her nail clippings and detected titanium in them by energy dispersive radiograph fluorescence. This patient's titanium exposure may have come from her habit of swallowing children's toothpaste. With meticulous avoidance of swallowing toothpaste, she had amelioration of her yellow nail discoloration as well as diminution of her respiratory symptoms. We reevaluated her nail clippings for titanium 3 years later, and no titanium was detected. This observation suggests that avoiding titanium exposure could alleviate the symptoms of YNS. This is the first report of YNS in a pediatric patient that demonstrates a relationship between YNS and titanium. We review the previous reports of pediatric patients with YNS.

Choice of toothpaste for the elderly: an in vitro study.

Hyposalivation and dental root exposure in the elderly are problems that require special oral care. In this context, the characteristics of certain toothpastes are of particular importance. Thus, the aim of this study was to evaluate the cytotoxicity and dentin wear caused by seven different toothpastes. For dentin wear analysis, 40 root dentin specimens were submitted to 20,000 brushing cycles with the different toothpastes and distilled water (control group-CG), using a brushing machine. Dentin surface loss (SL) was measured by contact profilometer. The cytotoxicity of each toothpaste was tested using cultured fibroblasts submitted to a cell-culture-conditioned medium. Fresh medium served as the control. Cell viability was assessed by MTT assay after 24 h of contact with the conditioned media. The data were analyzed statistically by ANOVA, followed by Tukey's test (p < 0.05). The SL of the CG was minimal and significantly lower than that of the Oral B Pro Health (OBPH) group (p < 0.05). All other groups presented SL in between that of the CG and the Oral B Pro Health OBPH group, except for the Sensodyne (SEN) group, which presented SL similar to that of CG (p = 0.05). The SEN group presented a percentage of viable cells similar to that of CG: between 60-89%. All the other toothpastes showed high cytotoxicity, with cell viability less than 50% of the CG. Considering study limitations, we concluded that only one of the seven tested toothpastes exhibited the most desirable toothpaste characteristics for the worldwide growing elderly population (e.g. low cytotoxicity and low-abrasive potential).

The in vitro impact of toothpaste extracts on cell viability.

Toothpastes contain three main components: detergents, abrasives, and fluoride. Detergents, particularly sodium lauryl sulfate, have been proposed as components that enable toothpastes to produce cytotoxic effects in vitro. However, not all toothpastes contain sodium lauryl sulfate, and almost no studies have found an association between detergents and the in vitro cytotoxicity of toothpastes. The present study examined the in vitro cytotoxicity of nine commercially available toothpastes containing four different detergents. Toothpastes were diluted in serum-free medium, centrifuged, and filter sterilized. The half-lethal concentration of the toothpaste-conditioned medium (TCM) was calculated based on the formation of formazan by gingival fibroblasts, oral squamous cell carcinoma HSC-2 cells, and L929 cells. Cell proliferation was analyzed, and live-dead staining was performed, after exposure of cells to conditioned medium prepared with 1% toothpaste (1% TCM). It was found that toothpastes containing sodium lauryl sulfate and amine fluoride strongly inhibited cell viability with the half-lethal concentration being obtained with conditioned medium prepared with approximately 1% toothpaste (1% TCM). Toothpastes containing cocamidopropyl betaine and Steareth-20 showed higher half-lethal concentration values, with the half-lethal concentration being obtained with conditioned medium prepared with 10% (10% TCM) and 70% (70% TCM) toothpaste, respectively. Proliferation and live-dead data were consistent with the cell-viability analyses. These results demonstrate that the type of detergent in toothpastes can be associated with changes in in vitro cell toxicity.

Choice of toothpaste for the elderly: an in vitro study

Hyposalivation and dental root exposure in the elderly are problems that require special oral care. In this context, the characteristics of certain toothpastes are of particular importance. Thus, the aim of this study was to evaluate the cytotoxicity and dentin wear caused by seven different toothpastes. For dentin wear analysis, 40 root dentin specimens were submitted to 20,000 brushing cycles with the different toothpastes and distilled water (control group-CG), using a brushing machine. Dentin surface loss (SL) was measured by contact profilometer. The cytotoxicity of each toothpaste was tested using cultured fibroblasts submitted to a cell-culture-conditioned medium. Fresh medium served as the control. Cell viability was assessed by MTT assay after 24 h of contact with the conditioned media. The data were analyzed statistically by ANOVA, followed by Tukey’s test (p < 0.05). The SL of the CG was minimal and significantly lower than that of the Oral B Pro Health (OBPH) group (p < 0.05). All other groups presented SL in between that of the CG and the Oral B Pro Health OBPH group, except for the Sensodyne (SEN) group, which presented SL similar to that of CG (p = 0.05). The SEN group presented a percentage of viable cells similar to that of CG: between 60-89%. All the other toothpastes showed high cytotoxicity, with cell viability less than 50% of the CG. Considering study limitations, we concluded that only one of the seven tested toothpastes exhibited the most desirable toothpaste characteristics for the worldwide growing elderly population (e.g. low cytotoxicity and low-abrasive potential).

Evaluation of some biological aspects of the presence of abrasive silica and thickening silica in basic formulations of dentifrices / Evaluación de algunos aspectos biológicos de la presencia de sílice abrasivo y sílice espesante en formulaciones básicas de dentífricos

The aim of this study was to evaluate some biological characteristics and toxicity of basic formulations of dentifrices containing such substances, and to compare them with two existing products in market which also contains silic in their formulations. In this way, it was evaluated some biological parameters: weight of the animals, oral toxicity, hematological parameters, urinary analysis, and histological evaluation. The thrombocytes were also statistically at normal levels. The glutamate-pyruvate transaminase (TGP) showed normal aspect in 5 of the tested groups, as in control. Meanwhile, the oxalacetic transaminase (AST) in one group had a small increase in the control group. Regarding urine, in exception the rats of one group, the rats of the 4 other experimental groups showed leukocytosis urinary statistically higher than the control group. The histological evaluation of the animals showed that specimens from liver, stomach, kidney and submandibular gland presented normal aspects for these organs, without significant characteristics related to inflammatory infiltrates in any of the 6 samples tested in their respective groups.

El objetivo del estudio fue evaluar algunas características biológicas y de toxicidad provenientes de las formulaciones básicas de dentífricos que contienen sílice en su composición y compararlos con dos dentífricos disponibles comercialmente que también presentan sílice. El análisis hematológico no mostró diferencias entre los grupos evaluados. Los niveles de trombocitos presentados por los grupos fueron también normales. La transaminasa gluámico pirúbica se mostró un aspecto normal en 5 de los grupos estudiados, así como en el grupo control. La transaminasa glutámico oxaloacética en uno de los grupos tuvo un pequeño incremento. En relación a la orina, 4 grupos presentaron leucocitosis urinaria significativamente mayor que el grupo de control. La evaluación histológica del hígado, estómago, riñones y glándulas submandibulares se presentó con aspecto normal, sin presencia de infiltrado inflamatorio.

The allergy of toothpaste: a case report

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Is bovine dentine an appropriate substitute for human dentine in erosion/abrasion tests?

The study aimed to compare the dentine wear of primary and permanent human and bovine teeth because of erosion/abrasion and evaluate if bovine dentine is an appropriate substitute for human dentine in further erosion/abrasions tests. Dentine samples from deciduous molars and human third molars as well as from calves' and cattle's lower incisors were prepared and baseline surface profiles were recorded. Each day all samples were demineralized in 1% citric acid, tooth brushed with 100 brushing strokes with toothpaste slurry and stored in artificial saliva for the rest of the day. This cycle was run for 20 days. Afterwards, new surface profiles were recorded and dentine wear was calculated by a customized computer program. Dentine wear because of erosion/abrasion was not statistically, significantly different for human third molars and cattle's lower incisors (P = 0.7002). The dentine wear because of erosion/abrasion of deciduous molars and calves' lower incisors was significantly different (P < 0.0000). No statistically significant difference in the dentine wear of human third molars and cattle's lower incisors was observed, so that the use of cattle's lower incisors as substitute for adult human teeth for further investigations in erosion/abrasion studies could be accepted.

Recovery from skeletal fluorosis (an enigmatic, American case).

UNLABELLED: A 52-year-old man presented with severe neck immobility and radiographic osteosclerosis. Elevated fluoride levels in serum, urine, and iliac crest bone revealed skeletal fluorosis. Nearly a decade of detailed follow-up documented considerable correction of the disorder after removal of the putative source of fluoride (toothpaste). INTRODUCTION: Skeletal fluorosis, a crippling bone disorder, is rare in the United States, but affects millions worldwide. There are no data regarding its reversibility. MATERIALS AND METHODS: A white man presented in 1996 with neck immobility and worsening joint pains of 7-year duration. Radiographs revealed axial osteosclerosis. Bone markers were distinctly elevated. DXA of lumbar spine (LS), femoral neck (FN), and distal one-third radius showed Z scores of +14.3, +6.6, and -0.6, respectively. Transiliac crest biopsy revealed cancellous volume 4.5 times the reference mean, cortical width 3.2 times the reference mean, osteoid thickness 25 times the reference mean, and wide and diffuse tetracycline uptake documenting osteomalacia. Fluoride (F) was elevated in serum (0.34 and 0.29 mg/liter [reference range: <0.20]), urine (26 mg/liter [reference range: 0.2-1.1 mg/liter]), and iliac crest (1.8% [reference range: <0.1%]). Tap and bottled water were negative for F. Surreptitious ingestion of toothpaste was the most plausible F source. RESULTS: Monitoring for a decade showed that within 3 months of removal of F toothpaste, urine F dropped from 26 to 16 mg/liter (reference range: 0.2-1.1 mg/liter), to 3.9 at 14 months, and was normal (1.2 mg/liter) after 9 years. Serum F normalized within 8 months. Markers corrected by 14 months. Serum creatinine increased gradually from 1.0 (1997) to 1.3 mg/dl (2006; reference range: 0.5-1.4 mg/dl). Radiographs, after 9 years, showed decreased sclerosis of trabeculae and some decrease of sacrospinous ligament ossification. DXA, after 9 years, revealed 23.6% and 15.1% reduction in LS and FN BMD with Z scores of +9.3 and +4.8, respectively. Iliac crest, after 8.5 years, had normal osteoid surface and thickness with distinct double labels. Bone F, after 8.5 years, was 1.15% (reference range, <0.1), which was a 36% reduction (still 10 times the reference value). All arthralgias resolved within 2 years, and he never fractured, but new-onset nephrolithiasis occurred within 9 months and became a chronic problem. CONCLUSIONS: With removal of F exposure, skeletal fluorosis is reversible, but likely impacts for decades. Patients should be monitored for impending nephrolithiasis.

Cytotoxicity of a new toothpaste based on an ion exchange resin mixture.

PURPOSE: To evaluate the effects for cytotoxicity of two dentifrices: a toothpaste commercially available (Crest Extra-Whitening toothpaste) and a new experimental toothpaste based on a mixture of ion-exchange resins (named NMTD) that supplies calcium, fluoride, phosphate and zinc ions. METHODS: Cultures of mouse fibroblasts cells L929 were used in a MTT assay for in vitro cytotoxicity of the dentifrices. Cells were cultured in Eagle's minimal essential medium supplemented with 10% fetal bovine serum. Cultures were incubated at 37 degrees C in a humidified atmosphere of 5% CO2 and collected by tripsinization (0.05% trypsin/0.5mM EDTA). A 96-well microplate method was employed for the MTT colorimetric assay. Positive control consisted of 10 microl of phenol in 5 ml of 6% media, a dose that produces zero percent cell survival. Negative control was prepared by adding 0.5 ml of HBSS to 4.5 ml of 6% media. The plates were incubated for 24 and 48 hours at 37 degrees C in a 5% CO2 atmosphere. RESULTS: Means and standard deviations of absorbance values for each group and percentage inhibitory dosage (%ID) for each test material were calculated. None of the dentifrices resulted in a percentage of inhibition higher than 50% and did not observe marked increases in cytotoxicity with time of incubation. The positive control gave almost zero percent cell survival, whereas the negative control gave a hundred percent cell survival. Analysis of the results indicated that test dentifrice dose had no significant effect towards the cell viability (P<0.05).

Acción antimicrobiana in vitro de dentífricos conteniendo fitoterápicos / Antimicrobial action in vitro of dentifricies with phytoterapeutics agents

Éste estudio analizó el potencial antimicrobiano in vitro de 7 dentífricos conteniendo sicoterápicos sobre bacterias orales recuperadas de la saliva y cepas patrón de S. mutans ATCC25175, S. sanguis ATCC 10556 y L. casei ATCC4646. Fueron obtenidas soluciones concentradas de los dentífricos evaluados y de controles mezclándose 3 gramos de cada uno con 10 mL de agua deionozada estéril, seguido de centrifugación; los sobrenadantes resultantes fueron diluidos en proporciones de 1:2 hasta 1:32. Fue realizado un test de difusión en ágar, colocando cepas patrón y la saliva total estimulada de 10 pacientes saludables. Discos empapados con las suspensiones de los dentífricos fueron dispuestos en las placas, las cuales fueron incubadas en anaerobiosis por 48 horas, siendo losaros de inhibición medidos en milímetros. Los resultados obtenidos fueron analizados mediante ANOVA y llevando en consideración el control positivo se constató que, solamente las soluciones puras de los dentífricos presentaron capacidad antimicrobiana contra cepas patrón, equivalente a la del dentífrico con triclosan, excepto el Gessy Cristal®. Además, los dentífricos diluidos a 1:2 presentaron acción antimicrobiana contra las bacterias orales recuperadas de la saliva, excepto el Parodontax® (AU)

The aim of this study was to evaluate and compare in vitro antimicrobial potential of 7 dentifrices containing phytotherapics agents oral bacteria obtained from saliva and standard strains of S. mutans ATCC 25175, S. sanguis ATCC 10556, and L. casei ATCC 4646. For this purpose, concentrated test and control solutions were obtained by mixing 3 grams of each in 10 ml of sterile deionized water which was submitted to centrifugation, the sublimate obtained was further dissolved in a ratio of 1:2 to 1:32. A diffusion test in agar was carried out by sowing the standard strain and stimulated total saliva. Disks soaked in a dentifrices solution and then placed on culture disks were then incubated in anarobiosis for 48 hours. Inhibition halos were then measured. Results obtained from ANOVA statistical analysis. However, comparison in the presence of a positive control, revealed that against standard strains, the pure solution of the dentifrices had antimicrobial activity, with the exception of Gessy Cristal®. Against oral bacteria recovered from saliva, diluted dentifrices to 1:2 showed the same activity, excepting Parodontax® (AU)

The effects of two sodium lauryl sulphate-containing toothpastes with and without betaine on human oral mucosa in vivo.

The aim was to compare the effects of two sodium lauryl sulphate (SLS)-containing toothpaste formulations with and without betaine on human oral mucosa in vivo. The results are compared with the effect of a dry mouth toothpaste without SLS. Twenty subjects participated in the double blind, crossover study. The toothpastes with 1.2% SLS, 1.2% SLS and 4% betaine and with 4% betaine but not with SLS were placed on buccal mucosa in a test chamber and kept in place for 15 min. The condition of the mucosa was studied both visually and using electrical impedance (EI) for up to 45 min. Both SLS-containing pastes had a similar, irritating effect on the mucosa as judged both by the appearance of the mucosa and the EI measurements. The dry mouth toothpaste (with betaine only) showed no significant irritation of the mucosa. Betaine did not reduce the mucosa-irritating effect of the SLS-containing toothpaste formulation. The surfactant-free toothpaste did thus not irritate the human oral mucosa in vivo while the SLS-containing pastes did.

Viadent usage and oral leukoplakia: a spurious association.

Oral rinse and toothpaste products (Viadent) containing Sanguinaria extract have been shown through extensive clinical trials to be effective against plaque build-up and gingivitis. To establish safety, a comprehensive research program was conducted, including a series of clinical studies and a number of animal studies to evaluate acute, subchronic, and chronic toxicity, and the potential for irritation of mucosal tissues. In 1990 and 1993, an Expert Panel reported on reviews of these data and concluded that Viadent products are safe for their intended use. Despite the large database of information to support the safety of Viadent products, Damm et al. (1999) recently raised the possibility that their usage may be causally associated with development of oral leukoplakia. However, a critique of this recent report shows that it does not fulfil criteria for establishing causation. In particular, the study does not show that exposure to Viadent preceded the onset of leukoplakia, it does not demonstrate dose-response or biological plausibility, and it suffers from selection and information bias and from potential confounding. Furthermore, upon critical evaluation, the Damm et al. (1999) report on a case-series is inconsistent with the weight of available clinical evidence showing that Sanguinaria extract-containing oral health care products cause no cytotoxic or significant irritant effects in the oral mucosa in human studies of up to 6 months duration. The animal data similarly do not support a causal association between Viadent usage and oral leukoplakia in humans. These data demonstrate that Sanguinaria extract and whole Viadent formulations are without significant irritation potential and have no effects on the oral mucosa, even in studies with life-long dietary exposure to Sanguinaria extract. The mutagenicity and genotoxicity data do not indicate that Sanguinaria extract or its components are genotoxic in vivo. The results of 2 GLP-compliant rat oncogenicity studies provide no evidence of any carcinogenic effect of Sanguinaria extract. In conclusion, the available clinical and animal data provide no support for and in fact argue strongly against the hypothesis that the use of Viadent toothpaste and/or oral rinse products may be causally associated with the development of leukoplakia in humans.

Toxicity of two carbamide peroxide products used in nightguard vital bleaching.

This study evaluated the effects of two generic classes of 10% carbamide-peroxide (CP) oxygenating agents (currently under clinical assessment for nightguard vital tooth bleaching) for lethality and genetic mutation after oral administration to mice, and for cellular cytotoxicity to mouse fibroblasts in vitro. The single dose LD50 values for a non-carbopol-containing CP (Gly-Oxide) and a carbopol-containing CP (Proxigel) in mice were found to be 143.8 mg/kg and 87.2 mg/kg, respectively. Genotoxicity, as measured by the Mouse Micronucleus test for mutagenicity, was negative for both 10% CP agents in comparison with positive and negative controls. Cytotoxicity as measured in the L929 fibroblast lysis assay resulted in 50% killing of L929 fibroblasts at 0.62 for the non-carbopol-containing CP and 1.88 mmol/L for the carbopol-containing CP. Both 10% CP agents were compared with seven widely-used dental products in the L929 fibroblast lysis assay and found to be no more toxic than these products.

[Comparative studies of toothpastes and toothpaste ingredients in biological systems. 2. Study of toothpaste ingredients and their effects on cell growth]. / Vergleichende Untersuchungen von Zahnpasten und Zahnpasten-Bestandteilen in biologischen Systemen: 2. Untersuchungen von Zahnpasten-Bestandteilen auf ihre zellwachstumsbeeinflussende Wirkung.

The influence on cell growth by different ingredients of toothpastes was examined in cell culture. Following parameters were evaluated: protein concentration, MTT-test and cell morphology. Substantial inhibition of cell growth was caused by tensides. Preparations with Tego-Betain had a significantly less influence on cell growth than Texapon. Other ingredients as medical soap, fluoride and preservative showed a very low effect.