Study on percutaneous penetration of representative cosmetic ingredients in a baby wipe product in an in vitro diaper rash skin model.

Studying percutaneous penetration of various cosmetic ingredients through intact and compromised skin can provide insight on quantitative exposure assessment for baby products intended for diapered skin. We developed an in vitro model (tape-stripped human skin) designed to achieve the Trans-Epidermal Water Loss values measured in babies with various degrees of diaper dermatitis. Six reference compounds showed the impact of physicochemical properties on absorption through this "diaper rash" skin model. Under simulated diaper conditions, dermal absorption of cosmetic ingredients (phenoxyethanol, sodium benzoate, benzyl alcohol, disodium EDTA, and propylene glycol) was different, but <100%. Additionally, the effect of diaper rash on dermal absorption of well-absorbed ingredients (phenoxyethanol, sodium benzoate, and benzyl alcohol) was limited (enhancement of 1.1-1.3), while the enhancement for moderately absorbed compounds (disodium EDTA and propylene glycol) was 1.8-3.3. Absorption via skin with "diaper rash" is specific to individual ingredients and exposure conditions, so a fixed uncertainty factor is not appropriate for safety assessment. The data support that the default 100% dermal absorption commonly used in first-tier risk assessments for diapered skin is conservative. This diaper rash skin model provides a practical tool of estimating absorption of various ingredients in baby products intended for diapered skin.

Psyllium is a natural nonfermented gel-forming fiber that is effective for weight loss: A comprehensive review and meta-analysis.

BACKGROUND: Psyllium is a natural, predominantly soluble fiber that forms a viscous gel when hydrated and is not digested or fermented. In the small intestine, psyllium gel increases chyme viscosity, slowing the degradation and absorption of nutrients. Psyllium has a significant effect in patients with metabolic syndrome and type-2 diabetes on glycemic control, while lowering serum cholesterol in hypercholesterolemic patients. Some randomized controlled studies have shown that psyllium also facilitates weight loss in overweight and obese participants. OBJECTIVES: A comprehensive review and meta-analysis assessing psyllium's impact on body weight, body mass index (BMI), and waist circumference in overweight and obese participants. DATA SOURCES: A comprehensive search was performed (Medline, Scopus, Cochrane Database) through March 21, 2022, using search terms to identify randomized, controlled, clinical studies designed to assess weight loss in overweight and obese participants over at least 2 months. Data were analyzed using the inverse variance method with random effects models. CONCLUSIONS: Six studies meeting inclusion criteria were identified (total n = 354). The meta-analysis showed that psyllium, dosed just before meals (mean dose 10.8 g/day, mean duration 4.8 months), was effective for decreasing body weight (MD = -2.1 kg [95% confidence interval [CI]: -2.6 to -1.6]; p < .001), BMI (MD = -0.8 kg/m 2 [95% CI: -1.0 to -0.6]; p < .001) and waist circumference (MD = -2.2 cm [95% CI: -2.9 to -1.4]; p < .001) in overweight and obese populations. IMPLICATIONS FOR PRACTICE: Gel-forming nonfermented psyllium fiber, dosed just before meals, is effective in facilitating weight loss in overweight and obese participants.

Understanding the impact funding cuts on Environmental and regulatory services and gastrointestinal infections: a longitudinal ecological study.

Background: Gastrointestinal (GI) infections result in 17 million cases annually, with foodborne illness costing the National Health Service (NHS) £60m per year. The burden of GI infection is unequally distributed, with greater impact in more socioeconomically disadvantaged groups and areas. Local authorities (LA) provide vital services that protect public health and wellbeing. The impact of funding cuts to local services and their effect on public health is an area of concern. Environmental and regulatory (ER) services are responsible for roles such as food safety and infectious disease control. This study aims to understand the impact of local funding cuts on ER and GI infection outcomes. Methods: We will conduct an ecological longitudinal study in England from 2010-2019 at the LA level to examine how changes in ER expenditure overtime have impacted ER and GI infection outcomes. Data will be gathered on food hygiene enforcement, food hygiene compliance levels, GI infection hospitalisation, NHS 111 calls relating to GI infection symptoms, GI infection pathogen data, deprivation, and population density. Measures will be aggregated to LA level and statistical analysis will be carried out. Ethics and dissemination: University of Liverpool Ethics committee have confirmed ethical approval will not be required. All data will be aggregated and anonymised, therefore only data sharing agreements will be required. Findings will be disseminated to the stakeholder group in addition to outputs through conferences and publications. These findings will help understand impact of key services on public health and should inform government and public health policy and strategy.

Systematic Review and Meta-Analyses Assessment of the Clinical Efficacy of Bismuth Subsalicylate for Prevention and Treatment of Infectious Diarrhea.

BACKGROUND: A large number of studies have evaluated the pharmacology, safety, and/or efficacy of bismuth subsalicylate for the relief of common gastrointestinal symptoms, diarrhea and vomiting due to acute gastroenteritis. In addition, short-term (48 h) medication with bismuth subsalicylate is known to be effective against infectious gastroenteritis such as travelers' diarrhea. AIMS: Previous studies have documented the bacteriostatic/bactericidal effects of bismuth subsalicylate against a variety of pathogenic gastrointestinal bacteria. However, meta-analyses of the clinical efficacy of bismuth subsalicylate for both prevention and treatment of travelers' diarrhea have not yet been published. METHODS: A total of 14 clinical studies (from 1970s to 2007) comprised the core data used in this assessment of efficacy of bismuth subsalicylate against infectious (including travelers') diarrhea. These studies allowed for statistical meta-analyses regarding prevention (three travelers' diarrhea studies) and treatment of infectious diarrhea (11 studies [five travelers' diarrhea]). RESULTS: The results show that subjects treated with bismuth subsalicylate for up to 21 days have 3.5 times greater odds of preventing travelers' diarrhea compared with placebo (95% CI 2.1, 5.9; p < 0.001). In addition, subjects with infectious diarrhea treated with bismuth subsalicylate had 3.7 times greater odds of diarrhea relief (recorded on diaries as subjective symptomatic improvement) compared to those receiving placebo (95% CI 2.1, 6.3; p < 0.001). CONCLUSIONS: This systematic review and meta-analysis suggests that bismuth subsalicylate can be beneficial for those at risk or affected by food and waterborne diarrheal disease such as traveler's (infectious) diarrhea, and may decrease the risk of inappropriate antibiotic utilization.

Diaper dermatitis prevalence and severity: Global perspective on the impact of caregiver behavior.

OBJECTIVES: To compare prevalence and severity of diaper dermatitis (DD) in infants and toddlers (babies) across three countries (China, USA, and Germany), including diapered skin measures and caregiver practices. METHODS: A cross-sectional study of 1791 babies (~600 from each country) was recruited at each clinical site. Based on regional toilet-training habits, exclusively diaper-wearing infants were recruited between ages 2-8 months in China and 2-18 months in the USA and Germany. DD was measured, as well as skin pH, transepidermal water loss (TEWL), and relative humidity (RH) in the diapered region. Caregiver habits were collected via a questionnaire and included information on hygienic practices. RESULTS: Diaper dermatitis was highest in the perianal area, followed by the intertriginous, genital, and buttock regions. In general, DD was significantly lower in babies in China, highest in Germany, and intermediate in the USA. This rank ordering of DD by geography was also observed in baby age 2-8 months. The lower DD observed in China was associated with lower skin pH and TEWL on diapered skin and decreased RH in the diaper. Chinese caregivers had the highest rate of prophylactic topical product usage, the most robust cleaning of the diapered area, lack of cleansing after urine-only diaper changes, and Chinese infants spent the least time in an overnight diaper. CONCLUSIONS: These data suggest caregiver behaviors including prophylactic use of topical products, thorough cleaning after stooling and reduced time in an overnight diaper are associated with less DD, lower superficial skin pH, and enhanced skin barrier.

Laxative effects of wheat bran and psyllium: Resolving enduring misconceptions about fiber in treatment guidelines for chronic idiopathic constipation.

BACKGROUND: Treatment guidelines for chronic idiopathic constipation (CIC) recommend an "increase in fiber intake" as a first-line therapy, but most epidemiologic studies fail to support an association between a high-fiber diet and a reduced risk of constipation. Furthermore, randomized controlled clinical studies show that most isolated fibers (e.g., supplements) are not different from placebo for a laxative effect, and several may be constipating. OBJECTIVES: The objective of this review was to compare the effects of two isolated fibers, coarse wheat bran and psyllium, on stool output and stool water content in patients with CIC. This review will also address misconceptions about fiber that are perpetuated by treatment guidelines. DATA SOURCES: A comprehensive literature review was conducted with the use of the Scopus, SciFinder, and PubMed scientific databases, limited to the previous 50 years (1968-2018; latest date included, December 31, 2018). CONCLUSIONS: In patients with CIC, nonfermented gel-forming psyllium was 3.4 times more effective than insoluble wheat bran for increasing stool output. Both psyllium and coarse wheat bran increased stool water content, a stool-softening effect, but finely ground wheat bran decreased stool water content, a stool-hardening effect. IMPLICATIONS FOR PRACTICE: It is a misconception that dietary fiber and all isolated fibers provide a laxative effect in patients with CIC. Our analysis suggests that treatment guidelines for CIC should make specific evidence-based recommendations as it pertains to fiber. To do otherwise takes the risk of perpetuating myth and misunderstanding and depriving patients of an effective therapy for CIC. A generic recommendation to "increase fiber intake" is akin to a recommendation to "increase pill intake" without regard to therapeutic or adverse effects.

Evaluation of the Impact of 2 Disposable Diapers in the "Natural" Diaper Category on Diapered Skin Condition.

The demand for natural infant care products, including diapers, has increased. However, few disposable diapers have been able to provide the performance caregivers desire while also incorporating ingredients consistent with the "natural" category. In an examiner-blinded clinical study, the performance of a new cotton-enhanced diaper with high-performance materials was compared with an existing natural diaper offering. A total of 131 infants wore 1 of the 2 diapers for a 4-week period. Diaper performance was assessed based on skin marking assessments, scored by a trained grader, and incidence of diaper dermatitis. Skin grading for diaper dermatitis was assessed at 4 sites in the diaper area. The new diaper offering was associated with less skin marking and significantly less diaper rash at the genitals and intertriginous regions versus the comparator. These data suggest that the new diaper provided significant improvement in both skin marking and prevalence of diaper rash.

Characterizing Exclusively Breastfed Infant Stool via a Novel Infant Stool Scale.

Analysis of stool has long been a diagnostic tool across a number of disease states. Currently, there are two stool scales in clinical use, the Bristol Stool Scale and the Amsterdam Infant Stool Scale. However, the existing categorizations for stool may not sufficiently cover the broad range of stool output for exclusively breastfed infants. The Bristol Stool Scale is not age specific to cover children who are not toilet trained and the Amsterdam Infant Stool Scale, though developed for children who are not toilet trained, does not sufficiently cover the wide variety of consistencies of exclusively breastfed infant stools. Through a robust understanding of exclusively breastfed infant stool characteristics, a new stool scale has been developed. It is proposed that this stool scale may better assist in observing and recording exclusively breastfed infant stool in a more accurate manner, which may aid in diagnostic capabilities.

The impact of diaper design on mitigating known causes of diaper dermatitis.

BACKGROUND: Diapers play a critical role in infant health. In addition to providing sanitary methods of disposing of urine and feces, they can also directly impact skin health. Prolonged exposure to wetness and fecal matter has been shown to be a key driver of diaper dermatitis. This study sought to evaluate how diaper construction can affect absorption of stool. METHODS: Methods included laboratory testing of stool absorbency as well as an at-home diaper evaluation study, which examined a diaper's ability to keep fecal matter from the skin. Breastfed infant stool was given special consideration, as its properties make it difficult to contain. RESULTS: Laboratory results demonstrated that a meshlike aperture diaper was better able to absorb fecal matter. The at-home diaper evaluation study confirmed that a meshlike aperture diaper design resulted in fewer instances of stool being present on skin during diaper changes. CONCLUSION: Diapers with a meshlike aperture topsheet may represent a better way to mitigate known causes of diaper dermatitis through their superior ability to absorb fecal matter.

Improving Diaper Performance for Extremely Low-Birth-Weight Infants.

BACKGROUND: Extremely low-birth-weight (ELBW) infants face significant diapering challenges compared with their full-term peers, due to immature musculature, nervous system, and skin development. Advances in medical care have increased an ELBW infant's rate of survival, which creates a growing need for diapers to better serve these infants. Aim of research. The objective of this study was to identify and confirm the requirements for optimal diaper performance from the neonatal intensive care unit nurses' perspective, as well as to assess in-hospital performance to determine if new features improved key developmental care parameters. METHOD: Two surveys were shared among nurses to address study objectives. Study 1 (N = 151) was designed for neonatal intensive care unit nurses to identify key requirements for ELBW diapers and rate the performance of existing ELBW diapers. Study 2 (N = 99) assessed in-hospital performance of the test diaper compared with the usual diaper, under normal usage conditions. Findings/results. The majority of nurses agreed that ELBW diapers must fit appropriately between the legs so that hips and legs are not spread apart and that ELBW diapers need to be flexible between the legs for positioning. Of the nurses-infant pair responses, 93% ( P < .0001) preferred the test ELBW diaper over their usual diaper. CONCLUSION: Findings suggest that nurses should be included in the product design process to ensure both their needs and the needs of an infant are being met. Nurses are considering how diaper features may affect both acute and long-term medical outcomes and this information provides necessary guidance to diaper manufacturers and designers when developing better-performing diapers.

Satiety effects of psyllium in healthy volunteers.

Controlling hunger between meals is a challenge for many individuals. This manuscript comprises 2 sequential clinical trials investigating the effects of psyllium (Metamucil) on satiety, both using a randomized, double-blind, placebo-controlled cross-over design. The first study determined the effects of 3.4 g, 6.8 g, and 10.2 g of psyllium taken before breakfast and lunch for 3 days. The second study determined the effects of 6.8 g (taken before breakfast and lunch on Days 1 and 2 and before breakfast on Day 3) on the satiety of participants receiving an energy restricted meal in the morning (breakfast) for 3 days. Efficacy endpoints were mean inter-meal hunger, desire to eat, and Satiety Labeled Intensity Magnitude Visual Analog Scale scores. In Study 1, all 3 psyllium doses resulted in directional or statistically significant mean reductions in hunger and desire to eat, and increased fullness between meals compared to placebo, with both higher doses better than placebo or 3.4 g. The 6.8 g dose provided more consistent (p ≤ 0.013) satiety benefits versus placebo. In Study 2, satiety was assessed similarly to Study 1. A significant (p ≤ 0.004) decrease in the 3-day mean hunger and desire to eat, as well as an increase in fullness for psyllium relative to placebo was observed. Most adverse events were mild gastrointestinal symptoms and were similar for psyllium compared to placebo. These results indicate that psyllium supplementation contributes to greater fullness and less hunger between meals.

Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus.

BACKGROUND: A number of health benefits are associated with intake of soluble, viscous, gel-forming fibers, including reduced serum cholesterol and the attenuation of postprandial glucose excursions. OBJECTIVE: We assess the effects of psyllium, which is a soluble, gel-forming, nonfermented fiber supplement, on glycemic control in patients who were being treated for type 2 diabetes mellitus (T2DM) and in patients who were at risk of developing T2DM. DESIGN: A comprehensive search was performed of available published literature (Scopus scientific database) and clinical records stored by Procter & Gamble with the use of key search terms to identify clinical studies that assessed the glycemic effects of psyllium in nondiabetic, pre-T2DM, and T2DM patients. RESULTS: We identified 35 randomized, controlled, clinical studies that spanned 3 decades and 3 continents. These data were assessed in 8 meta-analyses. In patients with T2DM, multiweek studies (psyllium dosed before meals) showed significant improvement in both the fasting blood glucose (FBG) concentration (-37.0 mg/dL; P < 0.001) and glycated hemoglobin (HbA1c) [-0.97% (-10.6 mmol/mol); P = 0.048]. Glycemic effects were proportional to baseline FBG; no significant glucose lowering was observed in euglycemic subjects, a modest improvement was observed in subjects with pre-T2DM, and the greatest improvement was observed in subjects who were being treated for T2DM. CONCLUSIONS: These data indicate that psyllium would be an effective addition to a lifestyle-intervention program. The degree of psyllium's glycemic benefit was commensurate with the loss of glycemic control. Because the greatest effect was seen in patients who were being treated for T2DM, additional studies are needed to determine how best to incorporate psyllium into existing prevention and treatment algorithms with concomitant hypoglycemic medications.

Evidence-based treatment of frequent heartburn: the benefits and limitations of over-the-counter medications.

PURPOSE: This review summarizes the pharmacological effects of over-the-counter (OTC) heartburn drugs, and the implications for treating frequent heartburn. DATA SOURCES: PubMed and SCOPUS were searched across all years to identify well-controlled, randomized clinical studies that assessed mechanism of action and efficacy. CONCLUSIONS: Antacids can transiently neutralize acid in the esophagus, but do not significantly affect gastric pH or prevent subsequent heartburn episodes. Histamine-2 receptor antagonists (H2 RAs) rapidly develop tolerance with repeat dosing, and exhibit an analgesic effect that may provide heartburn relief while leaving the esophagus exposed to acid. Proton pump inhibitors (PPIs) provide a sustained inhibition of gastric acid production, and are superior to antacids and H2 RAs for control of gastric acid and treatment of frequent heartburn. IMPLICATIONS FOR PRACTICE: When recommending therapies for frequent heartburn, it is of particular importance to understand the strengths and weaknesses of available OTC medications. Antacids and H2 RAs are not recommended for treatment of frequent heartburn, while OTC PPIs are both indicated for, and effective for, treatment of frequent heartburn. A PPI dose of 20 mg is optimal for empiric treatment of frequent heartburn, and consistent with the 2013 treatment guidelines established by the American College of Gastroenterology (ACG) for treatment with a minimum effective dose.

Doxylamine pharmacokinetics following single dose oral administration in children ages 2-17 years.

To characterize doxylamine pharmacokinetics in children. This study was conducted in 41 subjects, ages 2-17 years. Doxylamine succinate doses based on age/weight ranged from 3.125 to 12.5 mg. A single oral dose was administered with 2 to 4 oz. of water or decaffeinated beverages ∼2 hours after a light breakfast. Plasma samples were obtained before and for 72 hours after dosing and analyzed for doxylamine using HPLC MS/MS. Pharmacokinetic parameters were estimated using non-compartmental methods and relationships with age were assessed using linear regression. Over the fourfold dose range, Cmax was similar while AUC increased only 60%, although not statistically significant (P-value = 0.0517). As expected due to increasing body size, CLo and Vz /F increased with age. Due to a similar increase with age for Clo and Vz /F, no age-related differences in t1/2,z were observed (∼16 hours). Allometric scaling indicated no maturation related changes in CLo ; although Vz /F remained age-dependent, the predicted range decreased ∼70%. Overall, the single doses were well tolerated. Somnolence was the most common reported AE with no apparent differences in incidence noted with age. An age/weight dosing nomogram utilizing a fourfold range of doses achieves similar Cmax , whereas AUC increases only 60%.

Fecal excretion of Bifidobacterium infantis 35624 and changes in fecal microbiota after eight weeks of oral supplementation with encapsulated probiotic.

Certain randomized, placebo-controlled trials of oral supplementation with B. infantis 35624 have demonstrated the amelioration of symptoms of irritable bowel syndrome. Potential GI colonization by B. infantis 35624 or effects of supplementation on resident GI microbiota may pertain to these clinical observations. In this study, fecal excretion of B. infantis 35624 before, during and after 8 weeks of daily treatment was compared in subjects with IBS who received either the encapsulated oral supplement (n = 39) or placebo (n = 37) and in healthy subjects who received the supplement (n = 41). Secondarily, changes in assessed fecal microbiota and IBS symptoms were determined. Supplementation significantly increased fecal B. infantis 35624 excretion vs. placebo in IBS subjects; excretion in healthy subjects receiving supplement was quantitatively similar. Fecal levels of the probiotic declined and approached baseline once dosing ceased, documenting that colonization is transient. Although supplementation increased numbers of B infantis 35624 within the GI tract, limited changes in 10 other fecal taxa were observed either in healthy subjects or those with IBS. No impact on IBS symptoms was observed. Detection of bacterial DNA in fecal samples suggests that the probiotic is able to survive transit through the GI tract, although strain selective culture techniques were not performed to confirm viability of B. infantis 35624 in the feces. Continuous probiotic administration was necessary to maintain steady-state transit. Given the complex spectrum of GI microbiota, however, monitoring perturbations in selected taxa may not be not a useful indicator of probiotic function.

Gingival transcriptome patterns during induction and resolution of experimental gingivitis in humans.

BACKGROUND: To our knowledge, changes in the patterns of whole-transcriptome gene expression that occur during the induction and resolution of experimental gingivitis in humans were not previously explored using bioinformatic tools. METHODS: Gingival biopsy samples collected from 14 subjects during a 28-day stent-induced experimental gingivitis model, followed by treatment, and resolution at days 28 through 35 were analyzed using gene-expression arrays. Biopsy samples were collected at different sites within each subject at baseline (day 0), at the peak of gingivitis (day 28), and at resolution (day 35) and processed using whole-transcriptome gene-expression arrays. Gene-expression data were analyzed to identify biologic themes and pathways associated with changes in gene-expression profiles that occur during the induction and resolution of experimental gingivitis using bioinformatic tools. RESULTS: During disease induction and resolution, the dominant expression pathway was the immune response, with 131 immune response genes significantly up- or downregulated during induction, during resolution, or during both at P <0.05. During induction, there was significant transient increase in the expression of inflammatory and oxidative stress mediators, including interleukin (IL)-1 alpha (IL1A), IL-1 beta (IL1B), IL8, RANTES, colony stimulating factor 3 (CSF3), and superoxide dismutase 2 (SOD2), and a decreased expression of IP10, interferon inducible T-cell alpha chemoattractant (ITAC), matrix metalloproteinase 10 (MMP10), and beta 4 defensin (DEFB4). These genes reversed expression patterns upon resolution in parallel with the reversal of gingival inflammation. CONCLUSIONS: A relatively small subset (11.9%) of the immune response genes analyzed by array was transiently activated in response to biofilm overgrowth, suggesting a degree of specificity in the transcriptome-expression response. The fact that this same subset demonstrates a reversal in expression patterns during clinical resolution implicates these genes as being critical for maintaining tissue homeostasis at the biofilm-gingival interface. In addition to the immune response pathway as the dominant response theme, new candidate genes and pathways were identified as being selectively modulated in experimental gingivitis, including neural processes, epithelial defenses, angiogenesis, and wound healing.

The effects of high concentration tooth whitening bleaches on microleakage of Class V composite restorations.

OBJECTIVE: To explore the effects of high-concentration hydrogen peroxide bleaching agents on the microleakage of composite restorations. METHODS: In 60 extracted human molars, Class V restorations were prepared with Scotchbond 1/Filtek Z250 composite. Teeth were randomly divided into four groups: (1) no bleaching; (2) bleaching with 14% hydrogen peroxide gel from Crest Whitestrips; (3) bleaching with 20% carbamide peroxide gel from Opalescence PF 20; and (4) bleaching with 38% hydrogen peroxide gel Opalescence Xtra Boost. Bleaching procedures were carried out at 37 degrees C for 21 days/42 hours (2); seven days/42 hours (3); one day/45 minutes (4). Varnish was applied on the apical portion of the teeth only, excluding the restoration, prior to immersion in a 0.1% rhodamin-B-isothiocyanate solution for 24 hours at 37 degrees C. After rinsing, specimens were embedded in methacrylate blocks, and sectioned with a water-cooled microtome with three restoration cuts positioned centrally parallel to the long axis of the tooth. Microleakage was evaluated at the occlusal margins of the Class V restorations using a stereo microscope, separate for dentin and enamel margins. RESULTS: Over 90% of enamel margins exhibited no microleakage following cycling. Bleaching agents had almost no effect on numerical averages. Eighty-eight percent of the dentin margins were free of microleakage for the non-treated control group. Bleaching treatments collectively had slight numerical reductions to around 80%. The statistical evaluation (Kruskal-Wallis-test) showed no significant difference in microleakage between groups for enamel or dentin. CONCLUSION: Bleaching with the materials tested had no influence on microleakage of Filtek Z250 composite bonded with Scotchbond 1.

The effect of toothbrushing regimens on the plaque inhibitory properties of an experimental cetylpyridinium chloride mouthrinse.

OBJECTIVE: The objective of this study was to determine the effect of various toothbrushing regimens with a standard fluoride dentifrice on the plaque inhibitory properties of an alcohol-free, high bioavailable 0.07% cetylpyridinium chloride (CPC) mouthrinse. MATERIALS AND METHODS: The study was a randomized, single-centre, examiner blind, four-period cross-over study involving 29 healthy subjects. Four treatment regimens were evaluated: (1) Toothbrushing with dentifrice followed by a water rinse (B-W, negative control); (2) Toothbrushing with dentifrice followed by a CPC mouthrinse use (B-CPC); (3) Toothbrushing with dentifrice followed by a water rinse and then a CPC mouthrinse use (B-W-CPC); and (4) Toothbrushing with dentifrice and waiting 60 min. prior to a CPC mouthrinse use (B-60 min.-CPC). Three days before the baseline exam of treatment periods, subjects were instructed to brush only the lingual surfaces of their teeth for up to 60 s twice daily. At baseline, subjects received a plaque exam using the Turesky modification of the Quigley-Hein index (MQH) followed by a polishing on the lingual and buccal surfaces of their teeth. During treatment periods, subjects were asked to brush only the lingual surfaces of their teeth with a standard fluoride dentifrice. Rinsing with 20 ml of the experimental CPC solution was done for 30 s twice daily. The evening before the last day of treatment periods (Day 4), subjects were asked to refrain from any oral hygiene, eating, and drinking after brushing. On Day 4, plaque was scored using the MQH Index. A 10-day wash-out of normal oral hygiene was allowed between each of the four treatment periods. The data were analysed using analysis of covariance for cross-over designs. RESULTS: Twenty-five to 29 subjects were evaluable at any given visit. With respect to unbrushed buccal and brushed lingual surfaces, all three CPC regimens had highly significantly (p < or = 0.0006) lower mean plaque scores than the B-W regimen, reductions ranging from 20% to 38% in magnitude. With respect to unbrushed surfaces, there was a significant difference between the B-CPC regimen and the B-60 min.-CPC regimen (p < 0.01) in favour of the latter regimen. No other pairwise treatment comparisons were statistically significant for unbrushed sites. Results for brushed surfaces and all sites combined showed that both the B-W-CPC and the B-60 min.-CPC groups reduced mean plaque levels significantly (p < or = 0.013) more than B-CPC. There were no statistically significant differences between B-W-CPC and B-60 min.-CPC for measurements of brushed, unbrushed, or all sites combined. CONCLUSIONS: Results show that the alcohol-free, 0.07% high bioavailable CPC rinse provides an additive anti-plaque benefit beyond toothbrushing with a standard fluoride dentifrice regardless of the regimen. Of the regimens, a water rinse between toothbrushing and CPC rinsing enhances therapeutic efficacy while fitting into the patient's typical oral hygiene routine.

A 24-hour dental plaque prevention study with a stannous fluoride dentifrice containing hexametaphosphate.

Recently, a novel antibacterial fluoride dentifrice containing stannous fluoride and sodium hexametaphosphate (CrestPRO-HEALTH) was introduced. A digital plaque image analysis (DPIA) technique was used to quantify in situ plaque formation in a population carrying out a phased intervention protocol that included: (1) an initial treatment regimen including toothbrushing with standard sodium fluoride dentifrice in conventional bid brushing, (2) a second treatment regimen where a modified hygiene regimen was applied using standard sodium fluoride dentifrice including a period of 24 hours of non-brushing, and (3) a third treatment regimen where the 24-hour non-brushing regimen was continued using the antimicrobial stannous fluoride/sodium hexametaphosphate dentifrice. The quantitative evaluation of plaque formation was assessed in morning measurements following either standard evening hygiene (treatment period 1) or 24 hours since brushing (treatment periods 2 and 3). Post-brushing plaque measurements were also taken in each treatment regimen. Sixteen subjects completed all three treatment regimens with no side effects or oral complaints. Morning plaque coverage in treatment period 1 was 13.3%. Plaque coverage significantly increased in treatment period 2 when pre-bedtime brushing was discontinued, with 24-hour growth covering 18.4% of the dentition. Intervention of the antimicrobial stannous fluoride/hexametaphosphate dentifrice in treatment period 3 provided significant inhibition of plaque regrowth over 24 hours (15.2% coverage, a 17% reduction vs. sodium fluoride dentifrice control). These results support the strong retention and lasting antimicrobial efficacy of high stabilized stannous fluoride/sodium hexametaphosphate dentifrices.

Comparative clinical trial of two antigingivitis mouthrinses.

PURPOSE: To compare the safety and the antiplaque and antigingivitis efficacy of two oral rinses. METHODS: A randomized, double-blind, parallel groups, single-center study was conducted to evaluate the safety and efficacy of a high bioavailable, alcohol-free 0.07% cetylpyridinium chloride (CPC) rinse (Crest Pro-Health Rinse) and a positive control rinse containing essential oils (EO) and 21.6% ethyl alcohol (Cool Mint Listerine). Seventy-eight healthy adults were enrolled in a modified experimental gingivitis clinical trial. Four weeks before the baseline visit, subjects received a prophylaxis and were instructed to brush twice daily in a manner to approach optimum gingival health. At the end of the 4-week period, subjects were randomly assigned to treatment and instructed to use 20 ml of their assigned product for 30 seconds after brushing twice daily during a 21-day treatment phase. Plaque removal by brushing was prevented during the treatment phase for one mandibular quadrant (experimental gingivitis region) by means of a specially-manufactured tooth shield. Safety and efficacy measurements were obtained at baseline and at the end-of-treatment using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Modified Quigley-Hein Plaque Index (MQH). At all visits, an oral soft tissue examination was performed for each subject. The efficacy data obtained in the experimental gingivitis region were analyzed with analysis of covariance. RESULTS: Seventy-five subjects completed the study and were included in the data analyses. No statistically significant differences were detected between the two treatment groups for MGI, GBI or MQH measures. Results were similar for shielded interproximal sites. Both treatments were well-tolerated. CLINICAL SIGNIFICANCE: This randomized, controlled comparative clinical trial demonstrated that rinsing twice daily with the experimental alcohol-free 0.07% CPC rinse provides antiplaque and antigingivitis efficacy similar to that of the positive control EO rinse, a recognized antiplaque and antigingivitis mouthrinse that contains alcohol.