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Effect of an enzyme-containing mouthwash on the dental biofilm and salivary microbiome in patients with fixed orthodontic appliances: a randomized placebo-controlled pilot trial.
Hoffstedt, T, Skov Hansen, LB, Twetman, S, Sonesson, M
European journal of orthodontics. 2023;45(1):96-102
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Fixed orthodontic appliances are associated with dysbiosis in the oral cavity which may result in demineralisations of the enamel. Antiseptic mouthwashes have been shown to control the formation of cariogenic biofilm but may have negative effects on the salivary microbiome. The aim of this 8-day double-blind, randomised, placebo-controlled trial, including 35 adolescents with fixed orthodontics, was to evaluate the effect of an enzyme-based mouthwash (EBM), used twice daily, on dental biofilm (plaque) formation and salivary microbiome. At 8 days, a statistically and clinically significant decrease in the orthodontic plaque index was seen in the EBM group, whilst no change was seen in the placebo group. There were no statistically significant changes in microbiome between groups but a trend to increased richness in the placebo group. The authors concluded that the use of an enzyme-based mouthwash alongside regular toothbrushing reduced dental biofilm in adolescents with orthodontics without affecting the salivary microbiome.
Abstract
BACKGROUND Mouthwashes containing oral antiseptics or enzymes are suggested suitable for controlling biofilm accumulation in patients with fixed appliances and thereby limiting unwanted side effects during the orthodontic treatment. OBJECTIVES To evaluate the effect of an enzyme-based mouthwash on the amount of dental biofilm and the composition of the salivary microbiome in patients undergoing treatment with fixed orthodontic appliances. TRIAL DESIGN Randomized double-blind placebo-controlled trial. MATERIAL AND METHODS In total, 35 young adolescents (14-18 years) under treatment with fixed appliances were consecutively enrolled and randomly allocated to an experimental or a placebo group by opening a computer-generated numbered envelope. The subjects were instructed to rinse twice daily during an intervention period of 8 days with experimental mouthwash or placebo without active enzymes. Unstimulated whole saliva samples were collected at baseline and after 8 days. The participants and examiner were blinded for the allocation. The primary outcome was the Orthodontic Plaque Index (OPI) and the secondary was the composition of the salivary microbiome. RESULTS In total, 28 adolescents (21 females and 7 males) completed the trial and there were no differences in age, clinical, or microbial findings between the test (n = 14) and the placebo group (n = 14) at baseline. We found a decreased OPI in the test group after 8 days and the difference was statistically significant compared with the placebo group (P < 0.05). There were no significant treatment effects on the richness and global composition of the salivary microbiome. HARMS In total, one participant in the test group claimed nausea and abandoned the project. In total, two participants did not like the taste of the mouthwash but used it as instructed. No other adverse events or side effects were reported. LIMITATIONS Short-term pilot trials may by nature be sensitive for selection and performance biases and are not designed to unveil persisting effects. CONCLUSION Daily use of enzyme-containing mouthwash reduced the amount of dental biofilm in adolescents under treatment with the fixed orthodontic appliances, without affecting the composition of the salivary microbiota. ETHICAL APPROVAL Approved by the Regional Ethical Board, Lund, Sweden (Dnr 2020-05221). CLINICAL TRIAL REGISTRATION NCT05033015.
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Oral lactase for infantile colic: a randomized double-blind placebo-controlled trial.
Narang, M, Shah, D
BMC pediatrics. 2022;22(1):468
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Infantile colic – unexplained and inconsolable crying episodes without any identifiable cause in otherwise healthy infants - is a common problem. It has been postulated to be caused due to painful intestinal contractions, lactose intolerance, altered gut microbiota, aerophagy, food hypersensitivity and behavioural factors. Currently, there is no well-established treatment of infantile colic. The aim of this study was to evaluate the efficacy and safety of oral lactase enzyme supplements in management of infantile colic. The primary objectives were to compare crying or fussing duration and number of colic days, and the secondary objectives were to compare the parent satisfaction and adverse effects in children receiving lactase or placebo. This study is a randomised, double-blind, placebo-controlled trial. The enrolled infants (n = 162 children - 99 boys and 63 girls) were randomly assigned to receive five drops (0.2 mL) of the lactase enzyme preparation or placebo. Results show a significant reduction in crying and fussing duration in children receiving lactase drops prior to feeding in comparison to those receiving placebo during the entire 4-week treatment period. Furthermore, results show lesser number of days with colic, and better parental satisfaction in terms of positive change in child’s mood, alertness, activity and oral intake. Additionally, the treatment with lactase was well tolerated by all the infants as no serious adverse event was reported during the treatment. Authors conclude that oral lactase drops may result in significant symptomatic relief in infantile colic in terms of reducing the crying or fussing duration and number of colic days, resulting in better parental satisfaction.
Abstract
BACKGROUND Infantile colic is a common problem during the first three months of life. This randomized, double-blind, placebo-controlled trial conducted in an urban hospital in Delhi, India evaluated the efficacy and safety of oral lactase in management of infantile colic. METHODS One hundred sixty-two clinically healthy infants aged < 5 months age [mean (SD) = 63.5 (30.5) days] fulfilling the Rome-IV diagnostic criteria for infantile colic were enrolled. Eligible children were randomly allocated to receive 5 drops of lactase (600 FCC units/mL) (n = 80) or placebo (n = 82) mixed with breast milk or formula feed four times a day for a duration of 4 weeks. Primary outcomes were duration of crying or fussing (min/d), and number of days with colic lasting > 3 h/d; secondary outcomes were parental satisfaction and adverse events. RESULTS At the end of four weeks, mean (SD) crying or fussing time (min/d) was significantly shorter in infants receiving lactase in comparison to placebo [89.9 (115.2) vs.178.5 (153.2); P = 0.001]. The mean (SD) number of days with colic was also significantly less in the lactase group as compared to placebo group at the end of the treatment [12.1 (7.8) vs 17.6 (8.4); P < 0.001]. By the end of 4th week, parental satisfaction in terms of infant's mood, activity, alertness, comfort and oral intake was better in intervention group. The adverse event profile was comparable between two groups. CONCLUSIONS Oral lactase treatment in infantile colic results in symptomatic relief in terms of shortening of duration of crying or fussing, and better parental satisfaction. TRIAL REGISTRATION Clinical trial registry of India (CTRI/2017/12/010930) registered on 20/12/2017.
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The Effects of Extra Virgin Olive Oil on Alanine Aminotransferase, Aspartate Aminotransferase, and Ultrasonographic Indices of Hepatic Steatosis in Nonalcoholic Fatty Liver Disease Patients Undergoing Low Calorie Diet.
Shidfar, F, Bahrololumi, SS, Doaei, S, Mohammadzadeh, A, Gholamalizadeh, M, Mohammadimanesh, A
Canadian journal of gastroenterology & hepatology. 2018;2018:1053710
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Non-alcoholic fatty liver disease (NAFLD) is a risk factor for cardiovascular disease (CVD), which is the most common cause of death. The traditional Mediterranean diet has been shown to reduce the risk of NAFLD and CVD and this protective effect is thought to be in part due to the use of olive oil in this dietary pattern. The aim of this randomised, single-blind study was to evaluate the effect of virgin olive oil as part of a low-calorie diet on markers of NAFLD. 43 overweight or obese patients with NAFLD, characterised by increased liver enzymes (ALT and AST), were randomised to either a low calorie diet with normal fat or a low calorie diet with 20% of total energy intake from olive oil (overall percentage of fat 30% of total energy intake in both groups) for three months. Significant weight loss was observed in both groups, with no significant difference between groups. There was a reduction in liver enzymes in the olive oil group which was significantly greater than in the control group. The severity of liver steatosis (the accumulation of fat in the liver) did not change significantly in either group. The authors concluded that a low calorie diet with virgin olive oil led to slight weight loss and improvements in markers for NAFLD.
Abstract
Background: Coronary artery disease is the most common cause of death in the patients with nonalcoholic fatty liver disease (NAFLD). Studies have shown that there is a strong relation between the increase in the aminotransferase levels and fat accumulation in the liver with cardiovascular complications, independent of all aspects of the metabolic syndrome. This study aimed to examine the effect of virgin olive oil on alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the severity of steatosis in the NAFLD patients undergoing a weight-loss diet. Methods: This clinical trial was carried out on 50 patients with nonalcoholic fatty liver (mean age of 45.91 ± 9.61 years, mean BMI of 29.7 ± 0.58 Kg/m2) and the subjects were randomly assigned to the olive oil group (receiving the equivalent of 20% of their total daily energy requirement from olive oil) or the control group (with normal consumption of oil) for 12 weeks. All the patients received a hypocaloric diet during the study. At the beginning and the end of the study, the serum levels of ALT and AST and liver steatosis were measured. Findings: A significant decrease in the level of ALT enzymes was observed in the control group at the end of the study (P = 0.004). In the olive oil group, both enzymes decreased compared to baseline measurements (P < 0.01). There were significant differences in the ALT and AST levels between the two groups (P < 0.02). The severity of liver steatosis did not change significantly during the study. Conclusion: The consumption of a low calorie diet enriched with olive oil, along with slight weight reduction, reinforces the desired effects of weight loss in improving the levels of the hepatic enzymes.