METHODS: Dental models of 84 subjects were taken before orthodontic treatment and alveolar bone grafting. The mean age was 7.69 (SD 2.46) years. The DAR and PM were assessed blindly by five raters using the EUROCRAN index (EI). Kappa statistics was used to evaluate the intra- and inter-examiner agreement, chi square was used to assess the associations, and logistic regression analysis was used to explore the responsible factors that affect DAR and PM.
RESULTS: The mean EUROCRAN scores were 2.44 and 1.93 for DAR and PM, respectively. Intra- and inter-examiner agreement was moderate to very good. Using crude and stepwise backward regression analyses, significant associations were found between the modified Millard technique (P = 0.047, P = 0.034 respectively) of cheiloplasty and unfavorable DAR. Complete UCLP (P = 0.017) was also significantly correlated with unfavorable DAR. The PM showed a significant association with the type of cleft, type of cheiloplasty and type of palatoplasty.
CONCLUSION: This multivariate study determined that the complete type of UCLP and the modified Millard technique of cheiloplasty had significantly unfavorable effects on both the DAR and PM.
OBJECTIVE: To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in centrally obese subjects.
METHODS: Using a crossover design, randomized controlled trial in abdominally overweight men and women, we compared the effects of substitution of 7% energy as carbohydrate or MUFA for SAFA for a period of 6 weeks each. Fasting and postprandial blood samples in response to corresponding SAFA, carbohydrate, or MUFA-enriched meal-challenges were collected after 6 weeks on each diet treatment for the assessment of outcomes.
RESULTS: As expected, postprandial nonesterified fatty acid suppression and elevation of C-peptide, insulin and glucose secretion were the greatest with high-carbohydrate (CARB) meal. Interestingly, CARB meal attenuated postprandial insulin secretion corrected for glucose response; however, the insulin sensitivity and disposition index were not affected. SAFA and MUFA had similar effects on all markers except for fasting glucose-dependent insulinotropic peptide concentrations, which increased after MUFA but not SAFA when compared with CARB.
CONCLUSION: In conclusion, a 6-week lower-fat/higher-carbohydrate (increased by 7% refined carbohydrate) diet may have greater adverse effect on insulin secretion corrected for glucose compared with isocaloric higher-fat diets. In contrast, exchanging MUFA for SAFA at 7% energy had no appreciable adverse impact on insulin secretion.
METHODS: We conducted a pragmatic, multicenter, single-blind, controlled trial at 36 centers in 13 countries. Patients scheduled to undergo elective CABG were randomly assigned to an intraoperative anesthetic regimen that included a volatile anesthetic (desflurane, isoflurane, or sevoflurane) or to total intravenous anesthesia. The primary outcome was death from any cause at 1 year.
RESULTS: A total of 5400 patients were randomly assigned: 2709 to the volatile anesthetics group and 2691 to the total intravenous anesthesia group. On-pump CABG was performed in 64% of patients, with a mean duration of cardiopulmonary bypass of 79 minutes. The two groups were similar with respect to demographic and clinical characteristics at baseline, the duration of cardiopulmonary bypass, and the number of grafts. At the time of the second interim analysis, the data and safety monitoring board advised that the trial should be stopped for futility. No significant difference between the groups with respect to deaths from any cause was seen at 1 year (2.8% in the volatile anesthetics group and 3.0% in the total intravenous anesthesia group; relative risk, 0.94; 95% confidence interval [CI], 0.69 to 1.29; P = 0.71), with data available for 5353 patients (99.1%), or at 30 days (1.4% and 1.3%, respectively; relative risk, 1.11; 95% CI, 0.70 to 1.76), with data available for 5398 patients (99.9%). There were no significant differences between the groups in any of the secondary outcomes or in the incidence of prespecified adverse events, including myocardial infarction.
CONCLUSIONS: Among patients undergoing elective CABG, anesthesia with a volatile agent did not result in significantly fewer deaths at 1 year than total intravenous anesthesia. (Funded by the Italian Ministry of Health; MYRIAD ClinicalTrials.gov number, NCT02105610.).
METHOD: A single-blind RCT was conducted among 30 randomized patients with dental phobia to either VRET or informational pamphlet (IP) condition. Primary outcome anxiety measures (VAS-A, MDAS and DFS) were evaluated at baseline, pre- and post-intervention, 1-week, 3-months and 6-months follow-up. Secondary outcome measures assessed were pre-post behavioral avoidance, temporal variations of heart rate and VR-experience during and post-VRET, and dental treatment acceptance in both conditions at 6-month follow-up.
RESULTS: Intention to treat analysis, using a repeated measures MANOVA, revealed a multivariate interaction effect between time and condition (p = 0.015) for all primary outcome measures (all ps
METHODS: A randomized, single blinded, prospective, multicenter trial at 9 high-volume tertiary-care referral centers in the Asia-Pacific region was performed. Patients with an intact papilla and conventional anatomy who did not have malignancy in the head of the pancreas or ampulla and were undergoing ERCP were recruited. ERCP was performed by using a standardized cannulation algorithm, and patients were randomized to either a 0.025-inch or 0.035-inch guidewire. The primary outcomes of the study were successful wire-guided cannulation and the incidence of PEP. Overall successful cannulation and ERCP adverse events also were studied.
RESULTS: A total of 710 patients were enrolled in the study. The primary wire-guided biliary cannulation rate was similar in 0.025-inch and 0.035-inch wire groups (80.7% vs 80.3%; P = .90). The rate of PEP between the 0.025-inch and the 0.035-inch wire groups did not differ significantly (7.8% vs 9.3%; P = .51). No differences were noted in secondary outcomes.
CONCLUSION: Similar rates of successful cannulation and PEP were demonstrated in the use of 0.025-inch and 0.035-inch guidewires. (Clinical trial registration number: NCT01408264.).
METHODS: Twenty-two patients (11 male, 11 female; mean age, 19.8 ± 3.1 years) with Angle Class II Division 1 malocclusion were recruited for this split-mouth clinical trial; they required extraction of maxillary first premolars bilaterally. After leveling and alignment with self-ligating brackets (SmartClip SL3; 3M Unitek, St Paul, Minn), a 150-g force was applied to retract the canines bilaterally using 6-mm nickel-titanium closed-coil springs on 0.019 x 0.025-in stainless steel archwires. A gallium-aluminum-arsenic diode laser (iLas; Biolase, Irvine, Calif) with a wavelength of 940 nm in a continuous mode (energy density, 7.5 J/cm2/point; diameter of optical fiber tip, 0.04 cm2) was applied at 5 points buccally and palatally around the canine roots on the experimental side; the other side was designated as the placebo. Laser irradiation was applied at baseline and then repeated after 3 weeks for 2 more consecutive follow-up visits. Questionnaires based on the numeric rating scale were given to the patients to record their pain intensity for 1 week. Impressions were made at each visit before the application of irradiation at baseline and the 3 visits. Models were scanned with a CAD/CAM scanner (Planmeca, Helsinki, Finland).
RESULTS: Canine retraction was significantly greater (1.60 ± 0.38 mm) on the experimental side compared with the placebo side (0.79 ± 0.35 mm) (P <0.05). Pain was significantly less on the experimental side only on the first day after application of LLLI and at the second visit (1.4 ± 0.82 and 1.4 ± 0.64) compared with the placebo sides (2.2 ± 0.41 and 2.4 ± 1.53).
CONCLUSIONS: Low-level laser irradiation applied at 3-week intervals can accelerate orthodontic tooth movement and reduce the pain associated with it.
METHODS: This was a single-center, prospective, and single-blind randomized controlled trial conducted at the University Malaya Medical Centre. Patients older than 65 years presenting to the hospital emergency department or geriatric clinic with 1 injurious fall or 2 falls in the past year and with impaired functional mobility were included in the study. The intervention group received a modified OEP intervention (n = 34) for 3 months, while the control group received conventional care (n = 33). All participants were assessed at baseline and 6 months.
RESULTS: Twenty-four participants in both OEP and control groups completed the 6-month follow-up assessments. Within-group analyses revealed no difference in grip strength in the OEP group (P = 1.00, right hand; P = .55, left hand), with significant deterioration in grip strength in the control group (P = .01, right hand; P = .005, left hand). Change in grip strength over 6 months significantly favored the OEP group (P = .047, right hand; P = .004, left hand). Significant improvements were also observed in mobility and balance in the OEP group.
CONCLUSIONS: In addition to benefits in mobility and balance, the OEP also prevents deterioration in upper limb strength. Additional benefits of exercise interventions for secondary prevention of falls in term of sarcopenia and frailty should also be evaluated in the future.
METHODS: This is an assessor blinded randomized controlled trial comparing 2 intervention approaches namely ART-added physiotherapy (experimental group) and usual physiotherapy (control group). A total of 70 post-stroke patients will be recruited and allocated into either the ART-added physiotherapy or the usual physiotherapy group. The ART-added physiotherapy group will undergo a 20-minute ART session followed by 40 minutes of usual physiotherapy. While the usual physiotherapy group will receive usual physiotherapy alone for 60 minutes. All participants will be treated once a week and are required to carry out a set of home exercises for 2 times per week during the 12-week intervention. Assessment of emotional status and functional independence will be carried out at pre-intervention and week 13 of the intervention with the use of Hospital anxiety and depression scale, Barthel index, and EuroQol-5 dimensions-5 levels. All data will be analyzed using descriptive and inferential statistics.
DISCUSSION: The expected main study outcome is an enhanced evidence-based physiotherapy program that may be used by physiotherapists in the rehabilitation of stroke patients with emotional disturbances.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001664134 (last updated on 28/11/2019).
METHODS: A total of 138 American Society of Anesthesiologists (ASA) I to III patients were randomly assigned into 2 groups and underwent baseline laryngoscopy in the sniffing position. Group BUHE patients (n = 69) were then intubated in the BUHE position, while group GLSC patients (n = 69) were intubated using GLSC laryngoscopy. Laryngeal exposure was measured using Percentage of Glottic Opening (POGO) score and Cormack-Lehane (CL) grading, and noninferiority will be declared if the difference in mean POGO scores between both groups do not exceed -15% at the lower limit of a 98% confidence interval (CI). Secondary outcomes measured included time required for intubation (TRI), number of intubation attempts, use of airway adjuncts, effort during laryngoscopy, and complications during intubation.
RESULTS: Mean POGO score in group BUHE was 80.14% ± 22.03%, while in group GLSC it was 86.45% ± 18.83%, with a mean difference of -6.3% (98% CI, -13.2% to 0.6%). In both groups, there was a significant improvement in mean POGO scores when compared to baseline laryngoscopy in the sniffing position (group BUHE, 25.8% ± 4.7%; group GLSC, 30.7% ± 6.8%) (P < .0001). The mean TRI was 36.23 ± 14.41 seconds in group BUHE, while group GLSC had a mean TRI of 44.33 ± 11.53 seconds (P < .0001). In patients with baseline CL 3 grading, there was no significant difference between mean POGO scores in both groups (group BUHE, 49.2% ± 19.6% versus group GLSC, 70.5% ± 29.7%; P = .054).
CONCLUSIONS: In the general population, BUHE intubation position provides a noninferior laryngeal view to GLSC intubation. The laryngeal views obtained in both approaches were superior to the laryngeal view obtained in the sniffing position. In view of the many advantages of the BUHE position for intubation, the lack of proven adverse effects, the simplicity, and the cost-effectiveness, we propose that clinicians should consider the BUHE position as the standard intubation position for the general population.
METHODS: This single-blinded, randomized controlled trial was conducted in a single emergency department. Patients with acute long bone fractures and numerical rating scale (NRS) pain scores ≥ 6 following an initial dose of intravenous morphine were assigned to receive either a LDK (0.3 mg/kg) over 15 min or intravenous MOR at a dose of 0.1 mg/kg administered over 5 min. Throughout a 120-min observation period, patients were regularly evaluated for pain level (0-10), side effects, and the need for additional rescue analgesia.
RESULTS: A total of 58 subjects participated, with 27 in the MOR group and 31 in the LDK group. Demographic variables and baseline NRS scores were comparable between the MOR (8.3 ± 1.3) and LDK (8.9 ± 1.2) groups. At 30 min, the LDK group showed a significantly greater mean reduction in NRS scores (3.1 ± 2.03) compared to the MOR group (1.8 ± 1.59) (p = 0.009). Similarly, at 60 min, there were significant differences in mean NRS score reductions (LDK 3.5 ± 2.17; MOR mean reduction = 2.4, ± 1.84) with a p-value of 0.04. No significant differences were observed at other time intervals. The incidence of dizziness was higher in the LDK group at 19.4% (p = 0.026).
CONCLUSION: Short infusion low-dose ketamine, as an adjunct to morphine, is effective in reducing pain during the initial 30 to 60 min and demonstrated comparability to intravenous morphine alone in reducing pain over the subsequent 60 min for acute long bone fractures. However, it was associated with a higher incidence of dizziness.
TRIAL REGISTRATION: NMRR17318438970 (2 May 2018; www.nmrr.gov.my ).
METHODS: Twenty-six participants were randomly assigned to two groups to investigate the application location (left or right volar forearm) for the placebo and ZER creams. Both creams were topically administered to the volar forearms twice daily over a duration of 4 weeks. Initial skin irritation was assessed before and 30 min after applying creams. The melanin and erythema levels were quantified with Mexameter MX 18.
RESULTS: Twenty participants were included in the analysis. The cream formulation had excellent physical properties and was well-received by the participants. The initial skin irritation study results indicated that neither of the creams elicited an allergic reaction. The administration of ZER cream resulted in a statistically significant reduction in melanin levels (p