Two placebo-controlled crossover studies in healthy subjects to evaluate gastric acid neutralization by an alginate-antacid formulation (Gaviscon Double Action).

OBJECTIVE: To investigate the intragastric acid neutralization activity of a combined alginate-antacid formulation. SIGNIFICANCE: Published studies have investigated the reflux-suppressing alginate component of Gaviscon Double Action (Gaviscon DA; RB, UK) but intragastric acid neutralization activity of the antacid component has not been evaluated in vivo. METHODS: Intragastric pH monitoring, using a custom-made 10-electrode catheter, was evaluated in a two-part exploratory study in healthy subjects; Part I (n = 6) tested suitability of the catheter using antacid tablets (Rennie; Bayer, Germany); Part II (n = 12) evaluated gastric acid neutralization activity of Gaviscon DA liquid (20 ml) versus placebo in fasted subjects using a randomized, open-label, crossover design. The primary endpoint was the percentage of time that intragastric pH ≥4 was measured during 30 min post-treatment. A confirmatory study of identical design was subsequently conducted (n = 20). RESULTS: Monitoring pH using the multielectrode catheter was a viable approach, directly detecting changes in intragastric pH following a single dose of antacid tablets. In the exploratory study, the percentage of time that pH ≥4 during 30 minutes post-treatment was 46.8% with Gaviscon DA liquid versus 4.7% with placebo (p = 0.0004). These findings were supported by the confirmatory study, where pH ≥4 was recorded 50.8% of the time with Gaviscon DA versus 3.5% with placebo (p = 0.0051). In this study, Gaviscon DA was safe and well tolerated. CONCLUSIONS: These studies demonstrate the effective acid neutralizing capacity of Gaviscon DA versus placebo in healthy, fasted subjects. This adds to the evidence base for the combination of alginates and antacids.

A Histologic Perspective on Electrical and Thermal Burn-Injured Human Skin.

OBJECTIVE: To analyze specific spectroscopic (FT-Raman) and thermal (limiting oxygen index) aspects of skin samples exposed to electrical injury compared with thermal injury. METHODS: An observational case-control study was conducted at the Dr Stanislaw Sakiel Center for Burns Treatment in Siemianowice, Silesia, Poland. A scanning electron microscope was used to diagnose and illustrate the topography of skin samples from electrical and thermal burns and the morphologic effects on damaged versus undamaged skin surfaces. In particular, researchers attempted to detect spectroscopic and thermal changes at the molecular level, namely, specific biomarkers of tissue degeneration and their regeneration under the influence of the applied modifiers (antioxidants and orthosilicic acid solutions). RESULTS: Modification with L-ascorbic acid and hydrogel of orthosilicic acid caused an increase in the intensity of the amide I Raman peaks, whereas modification with sodium ascorbate and orthosilicic acid resulted in the separation of the band protein side chains (1,440-1,448 cm), which is a part of tissue regeneration. The best result was obtained when the skin was treated with 7% orthosilicic acid (limiting oxygen index, 26%). CONCLUSIONS: Antioxidant treatment may be advantageous in minimizing injury in patients with thermal burns but not always in electrical burns.

Fluoride activity of antibacterial ammonium hexafluorosilicate solution for the prevention of dentin caries.

PURPOSE: To evaluate the acid resistance of various antibacterial ammonium hexafluorosilicate (SiF) solutions. METHODS: Antibacterial SiF solutions were prepared with the addition of chlorhexidine (CHX), cetylpyridinium chloride (CPC), isopropyl methylphenol (IPMP), or epigallocatechin gallate (EGCG). Hydroxyapatite pellets were treated with SiF solution with or without antibacterial agents for 3 minutes. The demineralized depth of hydroxyapatite pellets after SiF treatment was measured using a surface roughness analyzer. RESULTS: SiF+CPC solution showed equivalent acid resistance to SiF and AgF treatment. In contrast, the original acid resistance activity of SiF solution was diminished by the addition of other antibacterial agents (CHX, IPMP and EGCG). SiF with the addition of CPC was the most effective for reducing the demineralized depth, showing the same levels as those of SiF and AgF. CLINICAL SIGNIFICANCE: The addition of CPC to the SiF solution did not reduce its fluoride activity, indicating that it may be useful for the prevention of dental caries. SiF with added antibacterial agents may have the potential to prevent dental caries.

Effect of alginate in patients with GERD hiatal hernia matters.

Alginate-based formulations are frequently used as add-on proton pump inhibitor (PPI) therapy to help control of heartburn and regurgitation. There are limited data regarding the mechanisms and effects of alginate-based formulations. We aimed to evaluate the effects of the sodium alginate intake and its likely temporal relations on intraesophageal reflux events by MII-pH in patients with and without hiatal hernia (HH). Fifty GERD patients (18 with HH, 32 without HH) with heartburn or regurgitation once a week or more common were included. After combined multichannel intraluminal impedance and pH-metry (MII-pH) had been performed, all patients were asked to eat the same standard meal (double cheeseburger, 1 banana, 100 g regular yoghurt, and 200 mL water with total energy value of 744 kcal: 37.6% of carbohydrates, 21.2% of proteins, and 41.2% of lipids) during two consecutive days. On separate random two consecutive days, all patients took 10 mL of sodium alginate (GA; Gaviscon Advance; Reckitt Benckiser Healthcare, Hull, UK) or 10 mL of water, 30 minutes after the refluxogenic meal. After eating refluxogenic meal, patients were examined ½ hour for basal conditions, 1 hour in upright, and 1 hour in supine positions. Alginate significantly decreased acid reflux after intake at the first hour in comparison to water in patients with HH (6.1 vs. 13.7, P = 0.004) and without HH (3.5 vs. 5.5, P = 0.001). Weakly acid reflux were increased at the first hour in patients with HH (3.4 vs. 1.3, P = 0.019) and without HH (1.7 vs. 5, P = 0.02) compared to water. There was no distinctive effect of alginate on the height of proximal migration of reflux events in patients with HH and without HH. Alginate decreases acid reflux events within a limited time period, especially at the first hour both in patients with and without HH. Alginate has no effect on the height of reflux events along the esophagus both in patients with and without HH.

A 12-week randomized, double-blind, placebo-controlled multicenter study of choline-stabilized orthosilicic acid in patients with symptomatic knee osteoarthritis.

BACKGROUND: The aim of this study was to assess the efficacy of choline-stabilized orthosilicic acid (ch-OSA) in patients with symptomatic knee osteoarthritis (OA). METHODS: In a multicenter, double-blind, placebo-controlled study, 211 patients with knee OA (Kellgren and Lawrence grade II or III) and moderate to moderately severe pain were randomly allocated to ch-OSA or placebo for 12 weeks. The primary outcome was the change in the WOMAC pain subscale from baseline to week 12. Secondary outcomes were changes from baseline to week 12 in WOMAC total, WOMAC stiffness, WOMAC physical function, Subject Global Assessment and levels of cartilage degradation biomarkers C-terminal telopeptide of collagen type II (CTX-II) and cartilage oligomeric matrix protein (COMP). Pre-specified subgroup analyses included the effect of gender. RESULTS: A total of 166 (120 women, 46 men) patients were included in the analysis (87 and 79 in the ch-OSA and placebo group, respectively). In the total study population, no differences were observed between the two treatment groups for the different outcomes but significant treatment x gender interactions were found. In men taking ch-OSA, a significant improvement in WOMAC total, WOMAC stiffness and WOMAC physical function as well as a lower increase in biomarker levels of cartilage degradation was observed, but not in women. The change in WOMAC pain showed a similar positive trend in men taking ch-OSA. CONCLUSION: After 12 weeks of treatment, no effect was found of ch-OSA in the total study population on clinical parameters and biomarkers, but a gender interaction was observed. In men, ch-OSA was found effective in reducing symptoms of knee OA, which was associated with a slight but significant reduction of biomarkers that are related to cartilage degradation. TRIAL REGISTRATION: The study was registered retrospectively: ISRCTN88583133 . Registration date: 2015-10-07.

Effect of theobromine-containing toothpaste on dentin tubule occlusion in situ.

OBJECTIVES: Dentin hypersensitivity (DH) is treated by either occlusion of dentin tubules or nerve desensitization. This in situ study compared dentin tubules occlusion by theobromine-containing dentifrices with (Theodent-classic-F®, TCF) and without (Theodent-classic®, TC) fluoride with 1,500 ppm fluoride toothpaste, Colgate®-Regular (Fluoride) and Novamin®-containing toothpaste, Sensodyne®-5000-Nupro (Novamin®). METHODS: Each subject wore four intraoral appliances bearing dentin blocks while using one of four test dentifrices (n = 20/dentifrice) twice daily for 7 days. The four appliances were removed successively after 1, 2, 3, and 7 days. Treated blocks and their control (untreated) blocks were examined with scanning electron microscopy (SEM). Effects were compared statistically (ANOVA/Tukey's) based on percentage of surface area covered by deposited precipitate layer (%DPL) and percentage of fully open (%FOT), partially occluded (%POT), and completely occluded (%COT) tubules in each block calculated relative to the number of tubules in their control blocks. RESULTS: SEM observation indicated an increased %COT and %DPL over time. After 1 and 2 days, %COT was comparable with TC and TCF, and significantly (p < 0.05) higher compared with Novamin® and Fluoride. Following 3 and 7 days, %COT was comparable among TC, TCF, and Novamin®, but remained significantly lower in Fluoride. At any time, %DPL was significantly (p < 0.05) higher in TC, TCF, and Novamin® compared with Fluoride. CONCLUSIONS: Theobromine-containing toothpastes with and without fluoride have equal potential in occluding dentin tubules within a shorter time period than Novamin®-containing toothpaste; however, the three demonstrated equal potential after 1 week, but not the fluoride toothpaste. CLINICAL RELEVANCE: Theobromine-containing toothpaste promoted dentin tubule occlusion thus shows potential to relief DH.

Comparison of effectiveness of abrasive and enzymatic action of whitening toothpastes in removal of extrinsic stains - a clinical trial.

OBJECTIVE: To compare the effectiveness of abrasive component (perlite/calcium carbonate) and enzymatic component (papain and bromelain) of whitening toothpaste in removal of extrinsic stains. METHODS: This study is a randomized, triple blind and parallel group study in which 90 subjects aged 18-40 years were included. At baseline, stains scores were assessed by Macpherson's modification of Lobene Stain Index and subjects were randomly assigned to two groups with 45 subjects in each. Group 1 used whitening toothpaste with enzymatic action and group 2 with abrasive action. After 1 month, stain scores were assessed for the effectiveness of the two toothpastes and 2 months later to check the stain prevention efficacy. Wilcoxson's test was used to compare between baseline 1 and 2 months stain scores, and Mann-Witney U-test was applied for intragroup comparison. RESULTS: The mean baseline total stain score for the subjects allocated to the enzymatic toothpaste was 37.24 ± 2.11 which reduced to 30.77 ± 2.48 in 1 month, and for the abrasive paste, total stain reduced from 35.08 ± 2.96 to 32.89 ± 1.95. The reductions in total stain scores with both the pastes were significant compared with baseline stain scores (at 1 month Group 1, P = 0.0233 and Group 2, P = 0.0324; at 2 months, Group 1 P = 0.0356). Both the toothpastes proved to be equally good in removal of extrinsic stains; however, the enzymatic paste showed better results as compared to abrasive toothpaste. CONCLUSION: Whitening toothpaste with abrasive action and enzymatic action are equally effective in removal of extrinsic stains; however, whitening toothpaste with abrasive action needs to be used with caution.

Pharmacological treatment of children with gastro-oesophageal reflux.

BACKGROUND: Gastro-oesophageal reflux (GOR) is a common disorder, characterised by regurgitation of gastric contents into the oesophagus. GOR is a very common presentation in infancy in both primary and secondary care settings. GOR can affect approximately 50% of infants younger than three months old (Nelson 1997). The natural history of GOR in infancy is generally that of a functional, self-limiting condition that improves with age; < 5% of children with vomiting or regurgitation continue to have symptoms after infancy (Martin 2002). Older children and children with co-existing medical conditions can have a more protracted course. The definition of gastro-oesophageal reflux disease (GORD) and its precise distinction from GOR are debated, but consensus guidelines from the North American Society of Gastroenterology, Hepatology and Nutrition (NASPGHAN-ESPGHAN guidelines 2009) define GORD as 'troublesome symptoms or complications of GOR.' OBJECTIVES: This Cochrane review aims to provide a robust analysis of currently available pharmacological interventions used to treat children with GOR by assessing all outcomes indicating benefit or harm. SEARCH METHODS: We sought to identify relevant published trials by searching the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 5), MEDLINE and EMBASE (1966 to 2014), the Centralised Information Service for Complementary Medicine (CISCOM), the Institute for Scientific Information (ISI) Science Citation Index (on BIDS-UK General Science Index) and the ISI Web of Science. We also searched for ongoing trials in the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com).Reference lists from trials selected by electronic searching were handsearched for relevant paediatric studies on medical treatment of children with gastro-oesophageal reflux, as were published abstracts from conference proceedings (published in Gut and Gastroenterology) and reviews published over the past five years.No language restrictions were applied. SELECTION CRITERIA: Abstracts were reviewed by two review authors, and relevant RCTs on study participants (birth to 16 years) with GOR receiving a pharmacological treatment were selected. Subgroup analysis was considered for children up to 12 months of age, and for children 12 months to 16 years of age, and for those with neurological impairment. DATA COLLECTION AND ANALYSIS: Trials were critically appraised and data collected by two review authors. Risk of bias was assessed. Meta-analysis data were independently extracted by two review authors, and suitable outcome data were analysed using RevMan. MAIN RESULTS: A total of 24 studies (1201 participants) contributed data to the review. The review authors had several concerns regarding the studies. Pharmaceutical company support for manuscript preparation was a common feature; also, because common endpoints were lacking, study populations were heterogenous and variations in study design were noted, individual drug meta-analysis was not possible.Moderate-quality evidence from individual studies suggests that proton pump inhibitors (PPIs) can reduce GOR symptoms in children with confirmed erosive oesophagitis. It was not possible to demonstrate statistical superiority of one PPI agent over another.Some evidence indicates that H2antagonists are effective in treating children with GORD. Methodological differences precluded performance of meta-analysis on individual agents or on these agents as a class, in comparison with placebo or head-to-head versus PPIs, and additional studies are required.RCT evidence is insufficient to permit assessment of the efficacy of prokinetics. Given the diversity of study designs and the heterogeneity of outcomes, it was not possible to perform a meta-analysis of the efficacy of domperidone.In younger children, the largest RCT of 80 children (one to 18 months of age) with GOR showed no evidence of improvement in symptoms and 24-hour pH probe, but improvement in symptoms and reflux index was noted in a subgroup treated with domperidone and co-magaldrox(Maalox(®) ). In another RCT of 17 children, after eight weeks of therapy. 33% of participants treated with domperidone noted an improvement in symptoms (P value was not significant). In neonates, the evidence is even weaker; one RCT of 26 neonates treated with domperidone over 24 hours showed that although reflux frequency was significantly increased, reflux duration was significantly improved.Diversity of RCT evidence was found regarding efficacy of compound alginate preparations(Gaviscon Infant(®) ) in infants, although as a result of these studies, Gaviscon Infant(®) was changed to become aluminium-free and has been assessed in its current form in only two studies since 1999. Given the diversity of study designs and the heterogeneity of outcomes, as well as the evolution in formulation, it was not possible to perform a meta-analysis on the efficacy of Gaviscon Infant(®) . Moderate evidence indicates that Gaviscon Infant(®) improves symptoms in infants, including those with functional reflux; the largest study of the current formulation showed improvement in symptom control but was limited by length of follow-up.No serious side effects were reported.No RCTs on pharmacological treatments for children with neurodisability were identified. AUTHORS' CONCLUSIONS: Moderate evidence was found to support the use of PPIs, along with some evidence to support the use of H2 antagonists in older children with GORD, based on improvement in symptom scores, pH indices and endoscopic/histological appearances. However, lack of independent placebo-controlled and head-to-head trials makes conclusions as to relative efficacy difficult to determine. Further RCTs are recommended. No robust RCT evidence is available to support the use of domperidone, and further studies on prokinetics are recommended, including assessments of erythromycin.Pharmacological treatment of infants with reflux symptoms is problematic, as many infants have GOR, and little correlation has been noted between reported symptoms and endoscopic and pH findings. Better evidence has been found to support the use of PPIs in infants with GORD, but heterogeneity in outcomes and in study design impairs interpretation of placebo-controlled data regarding efficacy. Some evidence is available to support the use of Gaviscon Infant(®) , but further studies with longer follow-up times are recommended. Studies of omeprazole and lansoprazole in infants with functional GOR have demonstrated variable benefit, probably because of differences in inclusion criteria.No robust RCT evidence has been found regarding treatment of preterm babies with GOR/GORD or children with neurodisabilities. Initiation of RCTs with common endpoints is recommended, given the frequency of treatment and the use of multiple antireflux agents in these children.

Protective effects of SnF2 - Part III. Mechanism of barrier layer attachment.

OBJECTIVE: To assess the ability of various fluoride salts to protect enamel against acid attack via a barrier mechanism. METHODS: Extracted human enamel specimens were cleaned and rinsed, then soaked in pooled human saliva for 1 hour to initiate formation of an early pellicle. Groups of three specimens each were etched for 10 minutes in 1% citric acid (pH 2.3), treated in a 1:3 slurry of dentifrice [1,100 ppm F as stannous fluoride (SnF2 ), 1,100 ppm F as sodium fluoride (NaF), 1,000 ppm F as sodium monofluorophosphate (SMFP), or 1,400 ppm F as amine fluoride (AmF)] and saliva for 2 minutes, exposed to 2% alizarin red-S (a calcium-selective dye) and rinsed again. The relative ability of each test product to deposit a barrier layer on the enamel surface was measured by its ability to protect against attachment of the calcium-selective dye. RESULTS: Specimens treated with the SnF2 dentifrice showed the least dye attachment, indicating a high level of surface protection. On a five-point scale, with 0 being no dye deposition (100% protection) and four being complete dye coverage (0% protection), the SnF2 -treated specimens scored an average of 0.25, with NaF scoring 3.4, SMFP scoring 3.4 and AmF scoring 3.7. Protection of the enamel surface was significantly higher for the SnF2 product than for the other products (P < 0.05), with no significant differences among the other three F salts. CONCLUSIONS: These results demonstrate that after an aggressive acid challenge, SnF2 deposits a barrier layer onto the pellicle-coated enamel surface, and the barrier layer which attaches onto acid challenged tooth surfaces is different from any that might be provided by treatment with the other fluoride compounds tested.

Erosion protection comparison of stabilised SnF2 , mixed fluoride active and SMFP/arginine-containing dentifrices.

PURPOSE: To investigate the relative erosion protection potential of marketed dentifrices formulated with either stabilised stannous fluoride (SnF2 ), sodium fluoride (NaF) and/or sodium monofluorophosphate (SMFP) using an established laboratory erosion cycling model. METHODS: Sound enamel cores from extracted, human enamel were cleaned, ground and polished, soaked in pooled saliva (pellicle formation) and treated with a 1:3 slurry of dentifrice and saliva. Specimens were subjected to daily challenges with 1% citric acid, a potentially damaging acid found in common food and drinks. Marketed dentifrices compared were: (1) a stabilised stannous fluoride product formulated with 1,100 ppm F as SnF2 ; (2) a cavity protection product containing 1,100 ppm F as NaF; (3) a cavity protection product comprising a mixed active fluoride system with 1,000 ppm F as SMFP + 450 ppm F as NaF; and (4) a sensitivity product containing 1,450 ppm F as SMFP + 8% arginine bicarbonate. RESULTS: Specimens from Group 1 demonstrated an average loss of 5.5 (±1.2) µm of tooth surface enamel; Groups 2, 3 and 4 lost an average of 18.3 (±0.9) µm, 16.0 (±2.0) µm and 17.1 (±1.1) µm, respectively, of tooth surface enamel. Group 1 provided a statistically significant difference in protection compared with the other products. CONCLUSIONS: These results suggest that the marketed dentifrice formulated with stabilised SnF2 may provide enhanced protection of exposed tooth surfaces against dietary acid attack compared with the other products tested.

Protective benefits of a stabilised stannous-containing fluoride dentifrice against erosive acid damage.

PURPOSE: To assess the potential of a stabilised stannous (Sn)-containing NaF dentifrice (Oral B/blend-a-Med(®) Pro-Expert), in addition to a number of other marketed European dentifrices formulated with various fluoride actives and two control dentifrices, to protect enamel against erosive acid damage. METHODS: Cores of human enamel (four per group) were soaked in pooled human saliva, and then treated with a 1:3 slurry (dentifrice:saliva) using a standardised in vitro erosion model (5-day cycling) that includes 10-minute challenges with 1% citric acid applied 60 minutes after each dentifrice treatment. Enamel surface loss was measured using transverse microradiography (TMR). RESULTS: Specimens treated with the Sn-containing NaF dentifrice showed 6.5 µm of surface loss ± 1.2 (SEM), which was not significantly different (P < 0.05, Fisher LSD) from that of a clinically proven, stabilised SnF2 positive control [Crest(®) Pro-Health, 1,100 ppm F as SnF2 : 3.0 µm of surface loss ± 1.1 (SEM)]. The Sn-containing NaF dentifrice and the clinically proven positive control both provided significantly greater protection (P < 0.05, Fisher LSD) compared with all of the other products tested. Enamel loss (SEM) values for other European products and the reference control (active agents) were: Meridol(®) : (1,400 ppm F as AmF + SnF2 ) 12.0 µm (1.47); Colgate(®) Cavity Protection: (1,450 ppm F as SMFP + NaF) 12.9 µm (1.66); Odol med 3(®) (1,400 ppm F as NaF) 14.2 µm (1.49); Elmex(®) (1,400 ppm F as AmF) 14.5 µm (1.76); Colgate(®) Enamel Protect: (1,450 ppm F as NaF + KNO3 ) 16.3 µm (2.02); Lacalut(®) aktiv: (1,400 ppm F as AlF3 ) 18.5 µm (1.71); Sensodyne(®) ProNamel(™) : (1,450 ppm F as NaF + KNO3 ) 20.5 µm (1.26); Crest Cavity Protection (1,100 ppm F as NaF, reference control) 22.00 µm (2.04); and Mentadent(®) : (1,450 ppm F as NaF + Zn citrate) 22.3 µm (0.63). CONCLUSION: These results support the potential for the stabilised, Sn-containing NaF dentifrice to provide erosion protection benefits that are not significantly different from the positive control benchmark for erosion protection (stabilised SnF2 ), and are significantly better than a broad range of dentifrice formulations available on the European market.

Role of Colgate Total toothpaste in helping control plaque and gingivitis.

PURPOSE: To assess the anti-plaque and anti-gingivitis effects of a dentifrice containing 0.3% triclosan, 2% copolymer and 0.243% (1,100 ppm) sodium fluoride in subjects with moderate plaque-induced gingivitis. METHODS: This was a single center, monadic study. Subjects had at least 20 teeth remaining in the functional dentition, excluding third molars. Following a baseline examination for plaque, gingival inflammation and bleeding, 75 qualified healthy adult males and females, ages 18-70 were selected to participate in the study. Dental prophylaxis was performed and subjects were provided with two tubes of toothpaste (Colgate Total) and a soft-bristle toothbrush (Colgate Wave Toothbrush). The subjects were instructed to brush twice daily using a modified Bass brushing technique. At the end of the 6- to 8-week period subjects returned for collection of clinical and subjective data. RESULTS: 75 subjects completed the study. Both clinical and subjective reductions were significant. The results showed statistically significant reductions in plaque index, gingival inflammation and bleeding on probing. The overall conclusion was that Colgate Total was a comprehensive dentifrice that produced a significant reduction in gingivitis, plaque, and bleeding.

A 12-week clinical study assessing the clinical effects on plaque metabolism of a dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride.

PURPOSE: To evaluate the clinical effect on plaque metabolism of a dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride compared to a commercially available dentifrice containing 1,450 ppm fluoride in a silica base. METHODS: A 12-week, parallel, randomized, double-blind study using 48 subjects was conducted at the Colgate-Palmolive Technology Center (Piscataway, NJ, USA). One group used a test dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride as sodium monofluorophosphate (MFP), and the other group used a commercial silica dentifrice with 1,450 ppm fluoride as sodium fluoride (NaF) as a control. Plaque metabolism analyses were conducted at baseline and after 2, 4, 6, 8, and 12 weeks of assigned product use. The plaque analyses included pH measurements before and after a sucrose rinse, ammonia production and lactic acid production. RESULTS: Subjects using the test dentifrice had significantly higher plaque pH values before (P< or = 0.01) and after (P< or = 0.045) a sucrose challenge than those using the commercially available control dentifrice. Subjects using the test dentifrice also produced higher levels of ammonia and lower levels of lactic acid compared to subjects using the control dentifrice.

Antimicrobial effect of Melaleuca alternifolia dental gel in orthodontic patients.

The aim of this study was to evaluate the antimicrobial effect and sensorial analysis of the gel developed with the essential oil of Melaleuca alternifolia. Thirty-four volunteers, divided into 2 groups, were monitored for 4 weeks. Initially, clinical biofilm (plaque index) and saliva samples (bacteria count) were collected, from which the standard values for each patient were obtained. For 7 days, group 1 used the melaleuca gel (Petite Marie/All Chemistry, São Paulo, Brazil), and group 2 used Colgate Total (S.B. Campo, São Paulo, Brazil). After 7 days, the plaque index was performed again, as well as the bacteria count and the sensorial analysis (appearance, color, odor, brightness, viscosity, and first taste sensation). The volunteers were instructed to return to their usual dental hygiene habits for 15 days. After this, group 1 started using Colgate Total, and group 2 started using the melaleuca gel, with the same evaluation procedures as the first week. The data were analyzed statistically with a significance level of 5%. In the bacteria count and clinical disclosure, the melaleuca gel was more effective in decreasing the dental biofilm and the numbers of bacteria colonies. According to the data from the sensory evaluation, Colgate Total (the control) showed better results regarding flavor and first sensation (P <0.05). We concluded that melaleuca gel is efficient in bacteria control but needs improvement in taste and first sensation.

[Update on gastroesophageal reflux disease]. / Puesta al día en el reflujo gastroesofágico.

Gastroesophageal reflux disease is a highly frequent disorder classically characterized by the presence of heartburn and/or acid regurgitation that improves with drug therapy that reduces acid content in the stomach. However, especially in patients with non-erosive disease, response to proton pump inhibitors is unsatisfactory in approximately 1 out of 3 patients, and consequently, in these patients, it is important to establish a definitive diagnosis and an alternative therapeutic strategy. In the last few years, advances have been made in knowledge of the physiopathology of reflux, such as identification of the role of the acid pocket in producing reflux, technological advances that allow differentiation among acid reflux, non-acid reflux and slightly acid reflux, and advances in the treatment of reflux with drugs that attempt to act on the barrier function of the esophagogastric junction.

Evaluation of a dentifrice containing 8% arginine, calcium carbonate, and sodium monofluorophosphate to prevent enamel loss after erosive challenges using an intra-oral erosion model.

OBJECTIVE: The objective of this study was to assess the ability of a dentifrice containing 8% arginine and calcium carbonate (Pro-Argin' Technology), and 1450 ppm fluoride as sodium monofluorophosphate (MFP) to prevent enamel loss from an erosive acid challenge in comparison to a silica-based dentifrice with 1450 ppm fluoride as MFP using an intra-oral erosion model. METHODS: The intra-oral clinical study used a double blind, two-treatment, crossover design. A palatal retainer was used to expose the enamel specimens to the oral environment during the five-day treatment period. The retainer was designed to house three partially demineralized bovine enamel samples. The study population was composed of 24 adults, ages 18 to 70 years. The study consisted of two treatment periods, with a washout period lasting seven (+/- three) days preceding each treatment phase. A silica-based dentifrice without fluoride was used during the washout period. The Test Dentifrice used in this study contained 8% arginine and calcium carbonate (Pro-Argin Technology), and 1450 ppm fluoride as sodium monofluorophosphate (MFP). The Control Dentifrice was silica-based and contained 1450 ppm fluoride as MFP. The treatment period lasted five days, during which the panelists wore the retainer 24 hours a day (except during meals and the ex vivo acid challenges) and brushed with their assigned product while wearing the retainer. The panelists brushed once in the morning and once in the evening each day for one minute, followed by a one-minute swish with the slurry and a rinse with 15 ml of water. The panelists brushed only their teeth and not the specimens directly. There were four ex vivo challenges with 1% citric acid dispersed throughout the day: two in the morning, one in the afternoon, and one in the evening. Mineral loss was monitored by a quantitative light fluorescence (QLF) technique. RESULTS: Twenty-three of 24 subjects successfully completed the study. The one subject who did not complete the study did so for reasons unrelated to the study or products used. The average percent mineral loss for the Test Dentifrice and Control Dentifrice was 9.74 +/- 13.23 and 18.36 +/- 14.14, respectively. The statistical analysis showed that the observed product differences were statistically significant (p < 0.001). CONCLUSION: The Test Dentifrice with 8% arginine, calcium carbonate, and 1450 ppm fluoride as MFP provided significantly better protection against erosive challenges in comparison to the Control Dentifrice with 1450 ppm fluoride as MFP.

Evaluation of a dentifrice containing 8% arginine, calcium carbonate, and sodium monofluorophosphate to repair acid-softened enamel using an intra-oral remineralization model.

OBJECTIVE: An intra-oral remineralization study was conducted to compare the ability of a dentifrice containing 8% arginine and calcium carbonate (Pro-Argin Technology), and 1450 ppm fluoride as sodium monofluorophosphate (MFP) to remineralize acid-softened bovine enamel specimens compared to a silica-based dentifrice with 1450 ppm fluoride as MFP. METHODS: The intra-oral clinical study employed a double blind, two-treatment, crossover design, and used an upper palatal retainer to expose the enamel specimens to the oral environment during product use and periods of remineralization. The retainer was designed to house three partially demineralized bovine enamel samples. The study population was comprised of 30 adults, ages 18 to 70 years. The study consisted of two treatment phases with a washout period lasting seven (+/- three) days preceding each treatment phase. A silica-based dentifrice without fluoride was used during the washout period. The Test Dentifrice used in this study contained 8% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP). The Control Dentifrice was silica-based and contained 1450 ppm fluoride as MFP. The treatment period consisted of a three-day lead-in period with the assigned product. The panelists brushed two times per day during the three-day lead-in period with the assigned product. On the fourth day, the panelists began brushing with the assigned product with the retainer in their mouth. The panelists brushed for one minute, followed by a one-minute swish with the slurry and a rinse with 15 ml of water in the morning, in the afternoon, and night with the retainer in the mouth. The panelists brushed only their teeth and not the specimens directly. Changes in mineral content before and after treatment were measured using a Knoop microhardness tester. RESULTS: The results of the study showed that percent remineralization values for the Test Dentifrice and Control Dentifrice were 14.99% and 8.66%, respectively. A statistical analysis showed that the Test Dentifrice was statistically significantly more effective at remineralizing acid-softened enamel in comparison to the Control Dentifrice (p < 0.05). CONCLUSION: This study demonstrated that the Test Dentifrice with 8% arginine, calcium carbonate, and 1450 ppm fluoride as MFP is highly effective treatment for promoting remineralization of enamel that has been softened by an erosive challenge.

Evaluation of anti-gingivitis benefits of stannous fluoride dentifrice among triclosan dentifrice users.

PURPOSE: To evaluate the anti-gingivitis benefits of a 0.454% highly bioavailable stannous fluoride dentifrice (SnF2) relative to a 0.3% triclosan/copolymer dentifrice (triclosan/copolymer) among triclosan/copolymer dentifrice users with residual gingivitis. METHODS: This was a randomized, controlled, double-blind, parallel group, 2-month clinical study. Self-reported triclosan/copolymer dentifrice users were recruited and provided with triclosan/copolymer dentifrice to use for 1 month. After this 1-month acclimation period, subjects who had residual gingivitis at the baseline visit were randomized to either the SnF2 dentifrice or the triclosan/copolymer dentifrice (positive control). Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers' usage instructions for 2 months. The Gingival Bleeding Index (GBI) and Modified Gingival Index (MGI) were used to measure gingivitis benefits at baseline and Month 2. An analysis of covariance was performed to compare treatment groups for the post-baseline scores as well as change from baseline, with the baseline score as a covariate. All comparisons were two-sided at the 0.05 level of significance. RESULTS: A total of 150 subjects were randomized to treatment. Both treatment groups experienced significant reductions in number of bleeding sites, gingival bleeding index (GBI), and gingival inflammation (MGI) relative to baseline (P < 0.001). At Month 2, the SnF2 dentifrice group demonstrated significantly lower adjusted mean scores versus the triclosan/copolymer group for number of bleeding sites, GBI, and MGI (P < 0.001). Between-treatment group comparisons for change from baseline values showed that the improvement in number of bleeding sites from baseline for the SnF2 group was 49% greater versus that of the triclosan/copolymer group (P < 0.001), and the GBI and MGI improvements from baseline for the SnF2 group were 48% and 37%, greater, respectively, relative to the triclosan/copolymer group (P < 0.001).

Determination of plaque viability following a single brushing with commercial toothpastes.

OBJECTIVE: The purpose of this study was to determine the viability of dental plaque at 12 hours following brushing with Colgate Great Regular Flavor (0.83% MFP), Crest Pro-Health (0.454% SnF), and Colgate Total Clean Mint Toothpaste (0.3% triclosan/ copolymer/0.22% NaF). METHODS: Thirty-two healthy volunteers from Bangkok, Thailand were chosen to participate in a double-blind clinical crossover study for three one-week treatment periods. They were randomly assigned to three groups using different sequences of test toothpastes. The plaque samples were collected at baseline (prior to brushing) and 12 hours after brushing with assigned toothpastes at the scheduled appointments. Scores and percentages of plaque viability were examined under a fluorescent microscope using a mixture of 40 microl of green and red fluorescent dyes, and were statistically analyzed using a two-way ANOVA. RESULTS: Plaque viability scores and percent plaque viability at baseline with all test toothpastes showed no significant differences with a p-value > 0.05. The post-treatment mean values of plaque viability scores for Colgate Great Regular, Crest Pro-Health, and Colgate Total 12 hours after brushing were 1.39, 3.01, and 3.37, and represented 90.06, 49.80, and 40.77 percent viable plaque, respectively. The Analysis of Variance (ANOVA) showed statistically significant differences when comparing Colgate Great Regular and Crest Pro-Health, Colgate Great Regular and Colgate Total, and Crest Pro-Health and Colgate Total using Tukey's test with a p-value < 0.001. CONCLUSION: Colgate Total, containing triclosan/copolymer/NaF as the active ingredients, is effective and superior to Crest Pro-Health and Colgate Regular in controlling the viability of oral bacteria in dental plaque.

Randomized trial of the clinical efficacy of a potassium oxalate-containing mouthrinse in rapid relief of dentin sensitivity.

OBJECTIVE: The aim of this randomized clinical trial was to evaluate the efficacy of a mouthrinse containing 1.4% potassium oxalate (Listerine Advanced Defence Sensitive; LADS) plus Colgate Cavity Protection Regular toothpaste, in reducing dentin sensitivity. METHODS: This was an observer- and examiner-blinded, randomized, parallel-group, single-center, controlled, five-day clinical trial. Healthy adults were randomized (2:1:1) to LADS plus Colgate Cavity Protection Regular toothpaste, or to one of the two negative-control toothpastes alone: Crest Cavity Protection Regular or Colgate Cavity Protection Regular. The subjects carried out supervised and unsupervised brushing and rinsing twice a day. Dentin sensitivity was assessed at baseline and during treatment by Yeaple probe (tactile pressure; patient-reported discomfort by visual analogue scale [VAS]), as well as response to air blasts (VAS). RESULTS: All sensitivity assessments were similar at baseline in the 56 randomized subjects. By the third day, the Yeaple probe sensitivity scores for subjects treated with Colgate toothpaste plus LADS improved significantly compared to Crest toothpaste alone (p < 0.05). By the fifth day, the mean scores for subjects treated with Colgate toothpaste plus LADS were significantly improved compared with subjects treated with either toothpaste alone (p < 0.05). The other sensitivity assessments showed that Colgate toothpaste plus LADS achieved statistically significant improvements compared with Colgate and/or Crest toothpaste alone from the third day. CONCLUSIONS: The 1.4% potassium oxalate mouthrinse (LADS) was associated with a reduction in dentinal sensitivity within a five-day period. Statistically significant reductions in all sensitivity variables were achieved by Day 3 and even greater reductions in dentin sensitivity scores were observed after five days.