scholarly journals Effect of Consuming Milk Tea with Stevia on Plaque pH among Dental Students: Cross-Over RCT

2021 ◽  
pp. 59-69
Author(s):  
CM Marya ◽  
Mandeep Kaur Sandhu ◽  
Ruchi Nagpal ◽  
Sakshi Kataria ◽  
Pratibha Taneja ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Repeated Measures ◽  
Dental Students ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Artificial Sweetener ◽  
Clinical Trial Registry ◽  
Time Intervals ◽  
Plaque Ph ◽  
Intergroup Comparison

Background: Stevia is a natural, healthy, unconventional replacement to the table sugar and artificial sweetener. Phytochemicals present in it exerts an influence on the microbial flora of the mouth. Hence, study was planned to compare the effects of stevia with different sugars on the plaque pH. Methodology: The present study was carried in department of Public Health Dentistry between 9am-12pm. It was a triple blinded Crossover Randomized Controlled Clinical Trial with LSD design. All the 40 subjects were exposed to all four interventions sequentially, at weekly intervals with 1 week wash out period. (Intervention: A- Table sugar, B- Jaggery, C- Stevia, D- Milk tea without sugar). Inferential statistics was done using Repeated measures of ANOVA followed by Post hoc pairwise comparison and Three-way RMANOVA to determine relationship between SUGAR * WEEK * TIME interaction. Level of significance was set at p value at 0.05. Results: Plaque pH assessments were performed at 4 points of time intervals (at baseline, 1 min, 20min, 60 min). Overall significance differences were seen in plaque pH at different time intervals for all interventions. Intergroup comparison showed potential efficacy of stevia in maintaining plaque pH. Conclusion: In the present study, it was found that stevia has the least cariogenic potential when compared with jaggery and refined sugar. Jaggery also did not show a significant reduction in plaque pH. Therefore, Stevia and Jaggery can be compared for their anti-cariogenic properties. This study has been registered under the Clinical Trial Registry of India CTRI/2020/12/03003

scholarly journals C-MAC D-Blade vs Airtraq for Intubation with Manual Inline Axial Stabilisation- A Randomised Clinical Trial

2021 ◽  
Author(s):  
Nikitha Mani ◽  
Nagalakshmi Palanisamy ◽  
Mamie Zachariah ◽  
Sagiev Koshy George ◽  
Allen Aloysius Dsilva ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Repeated Measures ◽  
Macintosh Laryngoscope ◽  
Randomised Clinical Trial ◽  
Significant Rise ◽  
P Value ◽  
Laryngoscopic View ◽  
Comparison Results ◽  
Intergroup Comparison

Introduction: One of the most important skills in anaesthesia is securing the airway with an endotracheal tube. Difficult tracheal intubation however is considered one of the major contributors of anaesthesia related morbidity and mortality. Video laryngoscopy offers several advantages during endotracheal intubation. The view of the glottis provided by Videolaryngoscopes is better compared to the Macintosh laryngoscope in difficult airways which makes it more attractive for routine difficult airway intubations. Aim: To compare the time taken for intubation between two Videolaryngoscopes, namely C-MAC D-blade and Airtraq and to assess the quality of laryngoscopy view between the two groups. Materials and Methods: This was a randomised clinical trial conducted in 116 American Society of Anesthesiologists 1 (ASA1) and ASA2 patients undergoing elective surgeries in Pondicherry Institute of Medical Sciences. Patients are randomised into two groups, Group C-MAC D-blade and Group Airtraq by computer randomisation. Statistical analysis was performed using t-test, Repeated measures of ANOVA was used to find the significance from preinduction to 10 mins period for each group and Bonferoni’s correction for intergroup comparison. Results: The time taken for intubation was comparable in two study groups (Group C-MAC D-blade 41.88 secs) and (Group Airtraq -40.78 sec) with p-value of 0.734. Laryngoscopic view was not statistically significant with p-value of 0.083. Optimisation maneuvers were required in 63.8% in Group Airtraq on comparison with 44.8% in Group C-MAC D-blade. In both Group C-MAC D-blade and Group Airtraq, there was a significant rise in the heart rate and BP at 0 minute compared to preinduction. But after 5 minutes, the heart rate and BP were back to preinduction values. Conclusion: Both the Videolaryngoscopes, C-MAC D-blade and Airtraq performed equally, with respect to time taken for intubation and laryngoscopic view. However, External Laryngeal Manipulation (ELM) was required more in Group Airtraq and was statistically significant.

scholarly journals Effect of Probiotics on Allergic Rhinitis: A Randomized, Controlled, Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1918 ◽  
Author(s):  
Mahnaz Sadeghi-Shabestari ◽  
Yalda Jabbari Moghaddam ◽  
Hasan Rezapoor ◽  
Mojataba Sohrabpour
Keyword(s):  
Clinical Trial ◽  
Allergic Rhinitis ◽  
Standard Therapy ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Nasal Discharge ◽  
Oral Corticosteroids ◽  
And Control

Background: Allergic rhinitis (AR) is one of the most common diseases in the world and affects about 10-50% of the general population. Probiotics are live microorganisms that help the normal state of the intestine, and if prescribed correctly, they can stimulate the mucosal immune system to prevent inflammatory symptoms of allergy and atopy. The present study aims to investigate the role of probiotics in the treatment of AR when added to standard therapy as adjuvant agents. Materials and Methods: In this clinical trial study, 28 patients older than 15 years with AR randomly divided into probiotics and control groups. The probiotics group received standard therapy for AR accompanied by probiotic capsules every 12 hours for eight weeks, whereas the control group received standard therapy for AR with placebo capsules as the same protocol. Data were analyzed using SPSS Version 23 (IBM Corporation, Armonk, NY, USA) and, the P-value less than 0.05 was considered statistically significant. Results: In the probiotics group, 14.3% of patients had sneezing at the baseline, which significantly decreased to 4.6% (P<0.01). Also, the necessity for nasal and oral corticosteroids after treatment with probiotics in the probiotics group was less than the control group (P<0.01). Although cough, nasal discharge, conchae hypertrophy, and night sleep disorders reduced after treatment with probiotics, this reduction was not statistically significant between the two groups. Conclusion: Based on the results of this clinical trial, the use of probiotics had no significant effect on the outcome of patients with AR. [GMJ.2020;9:e1918] 

scholarly journals Effect of a Vibration System on Pain Reduction during Injection of Dental Anesthesia in Children: A Randomized Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Muhanad AlHareky ◽  
Jehan AlHumaid ◽  
Sumit Bedi ◽  
Maha El Tantawi ◽  
Mazin AlGahtani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
The United States ◽  
Nerve Fibers ◽  
T Test ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Dental Anesthesia ◽  
Gate Control Theory

Background. The ‘‘gate control’’ theory suggests pain can be reduced by simultaneous activation of larger diameter nerve fibers using appropriate coldness, warmth, rubbing, pressure, or vibration. This study investigated the efficacy of a device combining cold and vibration, for needle-related procedural pain in children. Methodology. A total of 51 children aged 5–12 years participated in this randomized controlled clinical trial. Half of the children were in the control group and received maxillary buccal infiltration, by injecting 1.8 ml of 2% lidocaine with 1 : 100,000 adrenaline using topical anesthesia 20% benzocaine gel for 15 seconds, while the other half were in the test group and received the same anesthesia using a commercially available external cold and a vibrating device. A face version of Visual Analogue Scale (VAS) was used as a subjective measure to assess the child’s pain experience. The parents were requested to evaluate the child’s ability to tolerate pain using a behavioral/observational pain scale. Sound, Eyes, and Motor (SEM) scale and Faces, Legs, Activity, Cry, and Consolability (FLACC) scale were used to record the child’s pain as perceived by the external evaluator. T-test or Mann–Whitney U-test was used for scale variables, paired sample T-test or Wilcoxon rank t-test was used for before and after data, and chi-square was used for categorical variable, based on the results of normality test. Results. The results showed a statistically significant reduction in pain after the injection for the test group compared with control using VAS scale (mean = 6.68 (1.09) and 8.42 (0.50); p = 0.001 ) and FLACC scale (mean = 5.92 (1.05) and 8.16 (0.54); p = 0.002 ), but not when using SEM scale (mean 3.22 (0.42) and 4.24 (2.74); p = 0.08 ). Conclusions. Combined external cold and vibrating devices can be an effective alternative in reducing experienced pain and fear in children undergoing infiltration dental anesthesia. This study was registered with clinical trial registry of the United States National Institutes of Health (NIH) at ClinicalTrials.gov (NCT03953001).

scholarly journals Salivary pH changes under the effect of stainless steel versus elastomeric ligatures in fixed orthodontic patients: a single-center, randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hend Abulkarem Abdullah Al-Haifi ◽  
Ramy Abdulrahman Ali Ishaq ◽  
Maged Sultan Abdullah Al-Hammadi
Keyword(s):  
Clinical Trial ◽  
Stainless Steel ◽  
Orthodontic Treatment ◽  
Prolonged Treatment ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Enamel Demineralization ◽  
Salivary Ph ◽  
Ph Level ◽  
Level Of Significance

Abstract Background Fluctuations in pH of saliva during a prolonged treatment course influences the enamel demineralization progress, which is one of the complications of fixed orthodontic treatment. This randomized clinical trial aimed to evaluate and compare the short-term effects of stainless steel (SS) versus elastomeric (EM) ligatures on salivary pH in patients scheduled for fixed orthodontic treatment. Methods Seventy participants were enrolled in the study (54 female, 16 male) aged 19–36 years who met specific inclusion criteria. They were randomly selected and allocated into two equal groups through computer-generated randomization. All patients received fixed orthodontic treatment using conventional orthodontic brackets. Two commonly used archwire ligature methods were used: SS and EMs. An unstimulated (resting) salivary sample was collected before tying of the ligatures at T0 (baseline), 2 weeks, 6 (weeks), and 12 (weeks). Salivary pH was measured using a digital pH meter. The level of significance was set at p value < 0.05. Results The salivary pH level was stable between T0 and T1 (6.72 ± 0.14), then significantly and progressively increased from T1 to T2 (6.78 ± 0.13) and from T2 to T3 (6.81 ± 0.14) with (p < 0.05) in the SS group. In the EM group, the salivary pH level was significantly decreased in all follow-up periods; T0 (6.77 ± 0.16), T1 (6.72 ± 0.14), T2 (6.67 ± 0.13) and T3 (6.64 ± 0.13). Conclusion The EM ligatures showed a significant decrease in salivary pH to an unfavorable level, which increased the risk of enamel demineralization. Therefore, EMs as ligature material is preferably should not be recommended in patients with high caries index or inadequate oral hygiene. Trial registration ANZCTR.org. (ACTRN12618001647224) http://www.anzctr.org.au/ACTRN12618001647224.aspx. Registration Date: 5/10/2018, “Retrospectively registered”.

Effect of an early mobilisation programme on pain intensity after laparoscopic surgery: a randomised clinical trial

2020 ◽  
pp. bmjspcare-2020-002618
Author(s):  
Azam Dehghani ◽  
Ali Hajibagheri ◽  
Ismail Azizi-Fini ◽  
Fatemeh Atoof ◽  
Noushin Mousavi
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Surgery ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Early Mobilisation ◽  
Repeated Measures Analysis ◽  
The Mean

BackgroundPain is a common complication after laparoscopic surgery. This study aimed to examine the effect of an early mobilisation programme on postoperative pain intensity after laparoscopic surgery.MethodsA randomised controlled clinical trial was conducted on 80 patients who underwent laparoscopic surgery in Shahid Beheshti Hospital in Kashan, Iran. The patients were randomly allocated to intervention (n=40) and a control (n=40) group. In the intervention group, an early mobilisation programme was implemented in two rounds. The patient’s perceived pain was assessed using a Visual Analogue Scale 15 min before and 30 min after each round of early mobilisation. Data were analysed through the independent samples t, χ2 and Fisher’s exact tests and the repeated measures analysis.ResultsThe repeated measures analysis showed that the mean pain scores have been decreased over time (F=98.88, p<0.001). Considering the observed interaction between time and the intervention, the t test was used for pairwise comparisons and showed that the mean pain score was not significantly different between the two groups in 15 min before the first round of early mobilisation (p=0.95). However, the mean pain in the intervention group was significantly less than the control group in all subsequent measurements (p<0.05).ConclusionEarly mobilisation programmes such as the one implemented in the current study are easy and inexpensive and can be implemented safely for the reduction of pain after laparoscopic surgeries.

scholarly journals The Effect of Medium Chain Triglycerides on Time to Nutritional Ketosis and Symptoms of Keto-Induction in Healthy Adults: A Randomised Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Cliff J. d C. Harvey ◽  
Grant M. Schofield ◽  
Micalla Williden ◽  
Joseph A. McQuillan
Keyword(s):  
Clinical Trial ◽  
Healthy Adults ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Medium Chain Triglycerides ◽  
Clinical Trial Registry ◽  
Medium Chain ◽  
Low Carbohydrate ◽  
Randomised Controlled ◽  
Beta Hydroxybutyrate

Medium chain triglycerides (MCTs) are ketogenic and might reduce adverse effects of keto-induction and improve time to ketosis and the tolerability of very low carbohydrate diets. This study investigates whether MCT supplementation improves time to nutritional ketosis (NK), mood, and symptoms of keto-induction. We compared changes in beta-hydroxybutyrate (BOHB), blood glucose, symptoms of keto-induction, and mood disturbance, in 28 healthy adults prescribed a ketogenic diet, randomised to receive either 30 ml of MCT, or sunflower oil as a control, three times per day, for 20 days. The primary outcome measured was the achievement of NK (≥0.5 mmol·L−1 BOHB). Participants also completed a daily Profile of Mood States and keto-induction symptom questionnaire. MCT resulted in higher BOHB at all time points and faster time to NK, a result that failed to reach significance. Symptoms of keto-induction resulted from both diets, with a greater magnitude in the control group, except for abdominal pain, which occurred with greater frequency and severity in the MCT-supplemented diet. There was a possibly beneficial effect on symptoms by MCT, but the effect on mood was unclear. Based on these results, MCTs increase BOHB compared with LCT and reduce symptoms of keto-induction. It is unclear whether MCTs significantly improve mood or time to NK. The trial was registered by the Australia New Zealand Clinical Trial Registry ACTRN12616001099415.

scholarly journals Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Yu Wang ◽  
Yilei Guo ◽  
Ye Lei ◽  
Shuwei Huang ◽  
Liping Dou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Coronary Heart Disease ◽  
Heart Disease ◽  
Vascular Complications ◽  
Complementary Therapy ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Type 2 Diabetic

Background: Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of diabetic vascular complications. However, the evidence supporting the efficacy of Tongmai Jiangtang capsules in type 2 diabetic coronary heart disease (T2DM-CHD) remains unclear. Herein, we designed a randomized, parallel-controlled clinical trial to investigate a new complementary therapy for T2DM-CHD patients.Methods: A total of 360 T2DM-CHD subjects (aged 18–75 years) will be randomly assigned to the TJC group or the placebo group at a 2:1 ratio. On the basis of western medicine therapy, all the participants will receive TJC or placebo, orally, three capsules/treatment, three per day for 12 weeks. The primary outcomes will be assessed according to the Canadian Cardiovascular Society (CCS) classification. All statistical analyses will be performed setting a two-sided 0.05 significance level, using SAS 9.4 statistical software.Discussion: The efficacy of TJC for the treatment of T2DM-CHD patients will be evaluated. The study will provide reliable clinical research evidence for application of TJC in treating T2DM-CHD patients.Clinical Trial Registration:https://www.chictr.org.cn/enIndex.aspx, Chinese Clinical Trial Registry ChiCTR2000037491.

scholarly journals The Effect of Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial

2015 ◽  
Vol 4 (1) ◽  
pp. 26-32
Author(s):  
Sara Azima ◽  
Hajar Rajaei Bakhshayesh ◽  
Keramatollah Abbasnia ◽  
Maasumeh Kaviani ◽  
Mehrab Sayadi
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pharmacological Method

Background: Primary dysmenorrhea is the most common cyclic pelvic pain and is also the most common gynecological problem worldwide and affects quality of life. The present study aimed to investigate the effect of isometric exercises on intensity and duration of pain and level of anxiety in the students with primary dysmenorrhea.Materials and Methods: In this randomized controlled clinical trial, 68 students living in dormitories of Shiraz University with primary dysmenorrhea  were randomly assigned to isometric exercises and control groups. The intervention group performed isometric exercises since the third day of the menstrual cycle for 8 weeks. Pain intensity was measured using Visual Analog Scale (VAS). In addition, the anxiety level was assessed using Spielberger questionnaire. The data were analyzed using independent t-test, repeated measures ANOVA, and Bonferroni Post hoc test at the end of the second and third months of the study. Besides, P<0.05 was considered as statistically significant.Results: Pain intensity and duration of pain was significantly reduced in exercises group (p<0.001). However, no significant difference was found between the two groups concerning the mean anxiety levels.Conclusion: Primary dysmenorrhea is a common complaint among young women. Isometric exercises seem to be an easy, non-pharmacological method for reducing primary dysmenorrheal.

scholarly journals HEALING RATE IN DIABETIC FOOT ULCERS TREATED WITH BIOMEMBRANE AND HYDROCOLLOID POWDER: RANDOMIZED CLINICAL TRIAL

2021 ◽  
Author(s):  
Manuela de Mendonça Figueirêdo Coelho ◽  
Luciana Catunda Gomes de Menezes ◽  
Shérida Karanini Paz de Oliveira ◽  
Ana Débora Alcantara Coêlho Bonfim ◽  
Viviane Mamede Vasconcelos Cavalcante ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Diabetic Foot ◽  
Healing Rate ◽  
Foot Ulcers ◽  
Calotropis Procera ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Clinical Trial Registry ◽  
Experimental Group

Objective: to evaluate the rate of healing in diabetic foot ulcers treated with a biomembrane of latex proteins from Calotropis procera (BioMem CpLP) when compared to powdered hydrocolloid. Method: randomized controlled clinical trial, registered by the Brazilian Clinical Trial Registry (REBEC), according to protocol RBR-98f3j9, carried out with eight people with diabetic foot, in a diabetic foot clinic, from March to July 2019. In the experimental group (n = 04), biomembrane was applied; in the control group (n = 04), hydrocolloid powder was used. The healing rate was assessed at 30 and 60 days after starting treatment. Results: no statistical differences were found between the healing rates of the control group and the experimental group in the temporal analysis of the initial 30 days (p = 0.726) and in the 60 days following the start of treatment (p = 0.562). Conclusion: BioMem CpLP presented healing rates similar to the conventional product, being an effective and low cost alternative for the treatment of diabetic feet.

scholarly journals Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Yongliang Feng ◽  
Jing Chen ◽  
Tian Yao ◽  
Yue Chang ◽  
Xiaoqing Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Neutralizing Antibodies ◽  
Health Care Systems ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Shanxi Province ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registry

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational population. Methods In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data analysis. Results A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0–14, 0–21, and 0–28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95% CI: 88.4–108.4) in the 0–14 group, which was significantly lower compared with 134.4 (95% CI: 123.1–145.7) in the 0–21 group (P < 0.001 vs 0–14 group) and 145.5 (95% CI: 131.3–159.6) in the 0–28 group (P < 0.001 vs 0–14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were mild. Conclusions Both a two-dose of inactivated SARS-CoV-2 vaccine at 0–21 days and 0–28 days regimens significantly improved SARS-CoV-2 neutralizing antibody level compared to the 0–14 days regimen in high-risk occupational population, with seroconversion rates of 100.0%. Trial registration Chinese Clinical Trial Registry, ChiCTR2100041705, ChiCTR2100041706. Registered 1 January 2021, www.chictr.org.cn. Graphical Abstract

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