scholarly journals A tailored tooth brushing program to control plaque accumulation and gingivitis among orphan children: A randomized trial

2020 ◽  
Vol 3 ◽  
pp. 118-122
Author(s):  
Rajitharan Vijayasekaram ◽  
Osheda Senerath ◽  
Nivethika Thevarasah ◽  
Mohammed Habibulla Baig ◽  
S. S. Raj
Keyword(s):  
Tooth Brushing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Gingival Inflammation ◽  
Double Blind ◽  
Socially Disadvantaged ◽  
Gingival Health ◽  
Supragingival Plaque ◽  
Plaque Control ◽  
Chennai City

Objectives: Poor oral hygiene among children is major cause of gingivitis, caries, and especially orphans constitute socially disadvantaged group. The objective of the study was to assess the efficacy of a tailored tooth brushing program to improve supragingival plaque control and gingival health among 13–17-year-old orphan children in Chennai city over a period of 21 days. Materials and Methods: A double-blind parallel, controlled clinical trial was conducted among 60 orphan children (28 males and 32 females) with mean age of 15.24 years. Dental plaque was assessed using the Turesky modification of Quigley-Hein index; gingival inflammation was assessed using gingival index at initial visit and after 14 and 21 days. Subjects were randomly allocated into one of two groups (study – audiovisual and individual demonstration of brushing technique with reinforcement at 14 days follow-up/control – only individual demonstration) and instructed to brush twice daily using modified bass technique with the toothbrush and paste provided throughout the trial. Results: The children who had audiovisual, individual demonstrations of brushing technique exhibited significantly superior total oral plaque control and significant reduction in the gingival inflammation at the end of 21 days trial (P < 0.05). The study group participants reported improved compliance and motivation to practice modified bass technique because of the reinforcement. Conclusion: The children who had both audiovisual and individual demonstration exhibited superior total plaque control and gingival health compared to control group and continued to demonstrate modified bass technique without any reinforcement at the end of 21 days trial.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

Comparative Evaluation of 0.1% Octenidine Mouthwash with 0.2% Chlorhexidine Mouthwash in Prevention of Plaque and Gingivitis – A Clinicomicrobiological Study

2021 ◽  
Vol 13 (3) ◽  
pp. 202-210
Author(s):  
Sowmya Sadanandan ◽  
Suhas S ◽  
Sanjay Venugopal ◽  
Kavitha Karur
Keyword(s):  
Antibacterial Properties ◽  
Chlorhexidine Gluconate ◽  
Control Group ◽  
Double Blind Study ◽  
Gingival Inflammation ◽  
Patient Acceptability ◽  
Double Blind ◽  
Microbiological Parameters ◽  
Group B ◽  
The Impact

Background: Our study aimed to assess the efficacy of 0.1% Octenidine mouthwash as an anti-plaque agent and to assess its effect on gingival inflammation and staining of teeth when compared to 0.2% chlorhexidine gluconate by evaluating the impact on plaque and gingival inflammation as well as on microbial load. Materials and Methods: A three week double blind study was conducted on 69 subjects, aged 20-50 years, with moderate to severe gingivitis. The study population was divided into three groups with 23 subjects in each group: Group A - control subjects received only scaling, Group B received 0.2% chlorhexidine gluconate in addition to scaling and Group C received 0.1% Octenidine mouthwash along with scaling. Clinical and microbiological parameters were recorded at baseline, on 14th day and on 21st day. Subjective and objective criteria were assessed on the 14th day and 21st day. Results: There was a statistically significant reduction in all the tested parameters within all the three groups and between the groups from baseline to 21st day. The highest mean reduction in all the parameters was seen in subjects using 0.1% Octenidine. On comparison with the control group, subjects using the mouthwashes (Group B and Group C) had better improvement in clinical and microbiological parameters from baseline to 21st day. On comparison with chlorhexidine, Octenidine mouthwash significantly reduced plaque (p<0.05) and showed better patient acceptability. However, it was comparable to chlorhexidine in other two tested parameters. Conclusion: Owing to Octenidine’s pronounced and comparable antibacterial properties, it can be a promising candidate for the use in antiseptic mouthwashes.

scholarly journals Curcumin nanomicelle versus curcumin improves lipid profile, stress oxidative factors and inflammatory markers in patients undergoing coronary elective angioplasty; A Randomized Clinical Trial

2019 ◽  
Author(s):  
Bijan Helli ◽  
Hadis Gerami ◽  
Maria Kavianpour ◽  
Habib Heybar ◽  
Seyed Kianoosh Hosseini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Profile ◽  
Inflammatory Markers ◽  
Interleukin 1 ◽  
Stress Index ◽  
Inflammatory Factors ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Stress Oxidative

Abstract Background: Curcumin exhibited antioxidant and anti-inflammatory effects. The aim of this study, assess and compare curcumin and nano- curcumin effects on lipid profile, oxidative stress index and inflammatory factors of heart patients.Methods: This Randomized, Double-Blind, Placebo-Controlled Clinical Trial conducted on 90 patients undergoing coronary elective angioplasty. Patients were randomly divided into 3 groups. The first group received a 500 mg capsule of curcumin daily. The second group received an 80 mg capsule of nano- curcumin daily. The placebo group also received capsules similar to curcumin for 8 weeks. Lipid profile, stress oxidative factors and inflammatory markers measured in baseline and end of the investigation.Results: At the end of study, statistically significant changes was seen in the total cholesterol (TC), triglyceride (TG) and low density lipoprotein (LDL) in the intervention groups to the control group (p<0.05). These changes in the nano-curcumin group were greater than the curcumin group. Curcumin and nano-curcumin supplementation also caused a statistically significant improvement in plasma levels of total antioxidant capacity (TAC), malondialdehyde (MDA), Superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), high-sensitivity C-reactive protein (hs-CRP), Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) in comparison to the placebo (p<0.05).Conclusion: Complementary therapy of cardiovascular patients with curcumin and nano-curcumin supplements, could improve lipid profile, stress oxidative index and, inflammatory factors. The effects of curcumin on nano formula may be better for cardiac patients due to high bioavailability. However, further investigation is suggested in this regard.

scholarly journals Efficacy and Safety of Ejiao (Asini Corii Colla) in Women With Blood Deficient Symptoms: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Li Zhang ◽  
Zhongju Xu ◽  
Tao Jiang ◽  
Jialu Zhang ◽  
Pinxian Huang ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Blood Cell ◽  
Control Group ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Placebo Control Group ◽  
Sf 36

Equus asinus L [Equidae; Asini Corii Colla] (donkey-hide gelatin, Ejiao), a well-known traditional Chinese medicine, has been widely used to nourish the blood, especially for women. The aim of this study was to assess the efficacy and safety of Ejiao in blood-deficient patients. A total of 210 participants were recruited and randomly allocated into the placebo control group and Ejiao-treated group (6 g/day). The primary outcomes on the efficacy of Ejiao included traditional Chinese medicine symptom scores, blood indicators, and SF-36. The secondary outcomes were changes in fireness and safety evaluation. Results showed that Ejiao treatment for 8 weeks had significantly improved dizziness symptoms. Among the tested 24 blood biochemical parameters, the hematocrit and red blood cell numbers decreased in the placebo control group, but decreased significantly less in the Ejiao treatment group. The white blood cell and neutrophil counts increased in the Ejiao group but were within the normal range. In addition, the quality of life improved as the scores in SF-36 domains were significantly higher in the Ejiao group. At the same time, there was no significant change in the fire–heat symptoms score or other safety parameters. Considering all these, our study showed that Ejiao has a promising effect in women suffering from blood deficiency without obvious adverse effects.

scholarly journals THE EFFECTS OF CURCUMIN ADMINISTRATION ON EXPRESSION PATTERNS OF VEGF AND COX-2 IN FERTILE ENDOMETRIUM: A RANDOMISED CLINICAL TRIAL

2019 ◽  
pp. 149-152
Author(s):  
RAJUDDIN RAJUDDIN ◽  
BUDI WIWEKO ◽  
LUTFI NUGROHO
Keyword(s):  
Clinical Trial ◽  
Biological Activities ◽  
Expression Patterns ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Vegf Expression ◽  
Double Blind ◽  
Endometrial Stromal Cells ◽  
Cox 2 ◽  
Fertile Women

Objective: Curcumin (diferuloylmethane) is a a compound isolated from turmeric with biological activities, including antifertility. Curcumin inhibits COX-2 expression in granulosa cells of ovarian follicles and disrupts vascular endothelial growth factor (VEGF) derived angiogenesis in the endometrium, reducing endometrial receptivity. The purpose of this study was to examine the effects of curcumin on COX-2 and VEGF expression in endometrium of fertile women. Methods: A prospective double-blind placebo-controlled clinical trial was conducted in a group of fertile women with regular menstrual cycles, aged between 20-30 y, married, and with children. Subjects were divided into a group receiving daily 800 mg encapsulated curcumin. Curcumin orally for ten days, starting on the third day of the first menstrual day, and a control group. Endometrial biopsy was performed using a microcuret and immunohistochemistry was used to assess VEGF and COX-2 expression. The results were analysed using an independent sample t-test. Results: In the curcumin-treated group, VEGF expression was significantly lower than the control group (p<0.05), and COX-2 expression was higher but not significantly so (p>0.05). Conclusion: The curcumin causes VEGF expression in endometrium is lower and negatively affects the growth of endometrial stromal cells.

Vitamin D Treatment Attenuates Heart Apoptosis After Coronary Artery Bypass Surgery: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 25 (4) ◽  
pp. 338-345 ◽  
Author(s):  
Erfan Tasdighi ◽  
Manouchehr Hekmat ◽  
Mahmoud Beheshti ◽  
Ramin Baghaei ◽  
Seyed Mohsen Mirhosseini ◽  
...  
Keyword(s):  
Vitamin D ◽  
Coronary Artery ◽  
Coronary Artery Bypass ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Inflammatory Status ◽  
Significant Difference

Background: Vitamin D plays an important role in immune system and in the regulation of inflammatory cytokines. Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is associated with an extensive inflammatory response. The aim of this study is to examine the effect of vitamin D treatment on the apoptosis and inflammatory changes developed after CABG. Methods: This trial was conducted on 70 patients undergoing CABG with CPB. Patients were randomly administered either in placebo or in the group of orally consuming 150 000 IU vitamin D daily for 3 consecutive days before surgery. The right atrium sample was taken to assess caspases 2, 3, and 7 activity using immunohistochemistry method. The serum level of interleukin-10 (IL-10) and insulin-like growth factor 1 (IGF-1) were compared at intervals. Results: The average number of positive cells for caspases 2 and 3 were less in vitamin D group ( P = .006 and P < .001, respectively). There was an increase in serum levels of IL-10 after 3 days from vitamin D treatment before surgery (vitamin D group = 4.4 ± 4.9 ng/mL and control group = 1 ± 0.5 ng/mL, P = .001). After operation, IL-10 increased in both groups, higher level in vitamin D group ( P < .001). The comparison of serum IGF-1 showed significant difference after 3 days ( P = .006) and remained higher in vitamin D group after CPB ( P < .001). Conclusions: These findings suggest the apoptosis rate after CPB can be reduced by vitamin D. Vitamin D treatment may improve the inflammatory status before and after surgery. Further studies are needed to confirm the antiapoptotic property of vitamin D and clinical implication.

scholarly journals The Effects of a Low Glutamate Dietary Intervention on Anxiety and PTSD in Veterans with Gulf War Illness (FS15-08-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Elizabeth Brandley ◽  
Anna Kirkland ◽  
Gabrielle Sarlo ◽  
John VanMeter ◽  
James Baraniuk ◽  
...  
Keyword(s):  
Anxiety Disorders ◽  
Dietary Intervention ◽  
Monosodium Glutamate ◽  
Gulf War ◽  
Rank Test ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Gulf War Illness ◽  
Double Blind ◽  
Funding Sources

Abstract Objectives Glutamate is an amino acid and also serves as the most ubiquitous neurotransmitter in the human body. Previous work has shown that dysregulated glutamatergic neurotransmission is implicated in the etiology of anxiety disorders. Objective: To examine the effect of a low glutamate dietary intervention on anxiety and Posttraumatic Stress Disorder (PTSD) in veterans with Gulf War Illness (GWI). Methods Forty veterans with GWI are being recruited for a randomized-controlled clinical trial testing the effects of a low glutamate diet on neurological symptoms. After consent, subjects complete baseline measures, then subjects are randomized to the low-glutamate diet or a wait-listed control group. For the active intervention phase, they follow a 1-month low glutamate diet and then are re-tested prior to entering a double-blind, placebo-controlled crossover challenge with monosodium glutamate (MSG) or placebo, to test for return of symptoms. Preliminary data are presented here for changes observed on the Generalized Anxiety Disorder 7-item (GAD-7) scale and the PTSD Checklist (PCL-C) after one month on the diet in subjects recruited to date. Pre-post diet scores were compared for anxiety and PTSD using a Wilcoxon Signed Rank test in SAS. Results Seventeen veterans (M = 15; F = 2) with GWI have been recruited to date (mean age = 50 ± 4 yrs). Preliminary analyses demonstrate that after one month on the diet, significant improvements were noted for anxiety (score reduced from a median (IQ range) of 9 (13) to 5 (10), p = 0.01) and for PTSD (median (IQ) score reduced from 58 (33) to 43 (28), p = 0.04). Conclusions This study suggests that consuming a low glutamate diet may improve anxiety and PTSD in veterans suffering from Gulf War Illness. More research is needed to further explore the role of dietary glutamate in anxiety disorders. Funding Sources U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Gulf War Illness Research Program under Award No. W81XWH-17-1-0457. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

Pre-emptive triple analgesia protocol for tonsillectomy pain control in children: double-blind, randomised, controlled, clinical trial

2013 ◽  
Vol 127 (4) ◽  
pp. 383-391 ◽  
Author(s):  
A M A El-Fattah ◽  
E Ramzy
Keyword(s):  
Postoperative Pain ◽  
Visual Analogue Scale ◽  
Analogue Scale ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Post Surgery ◽  
Scale Scores ◽  
Randomised Controlled ◽  
At Home

AbstractIntroduction:This double-blind, controlled, parallel-group study was designed to determine the efficacy of pre-emptive triple analgesia for paediatric post-tonsillectomy pain management.Materials and methods:One hundred and thirty-five children were randomised into two groups: pre-emptive triple analgesia (n = 55) and control (n = 80). Pain was assessed using a visual analogue scale (in hospital) and the Parent's Postoperative Pain Measure (at home), and scores recorded.Results:Visual analogue scale scores on awakening and for 6 hours post-surgery were significantly better in the study group than the control group (p < 0.05). The Parent's Postoperative Pain Measure scores of control group children were significantly higher within the first 3 post-operative days (p = 0.000), with a greater percentage of children experiencing significant pain and requiring more analgesia.Conclusion:The proposed multimodal, pre-emptive analgesia protocol for paediatric post-tonsillectomy pain results in less post-operative pain, both in hospital or at home.

scholarly journals Acupuncture to Reduce HIV-Associated Inflammation

2015 ◽  
Vol 2015 ◽  
pp. 1-6
Author(s):  
Barbara Swanson ◽  
Joyce K. Keithley ◽  
Angela Johnson ◽  
Louis Fogg ◽  
Oluwatoyin Adeyemi ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Plasma Concentrations ◽  
High Sensitivity ◽  
Neural Mechanism ◽  
Sham Acupuncture ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Inflammatory Conditions ◽  
Anti Inflammatory

Background. HIV infection is associated with systemic inflammation that can increase risk for cardiovascular events. Acupuncture has been shown to have immunomodulatory effects and to improve symptoms in persons with inflammatory conditions.Objective. To test the anti-inflammatory effects of an acupuncture protocol that targets the cholinergic anti-inflammatory pathway (CAIP), a neural mechanism whose activation has been shown to reduce the release of proinflammatory cytokines, in persons with HIV-associated inflammation.Design, Setting, Participants, and Interventions. Double-blind, placebo-controlled clinical trial conducted in an outpatient clinic located in a medically underserved urban neighborhood. Twenty-five clinically-stable HIV-infected persons on antiretroviral therapy were randomized to receive once weekly CAIP-based acupuncture or sham acupuncture.Main Outcome Measures. Outcomes included plasma concentrations of high sensitivity C-reactive protein and D-dimer and fasting lipids.Results. Twenty-five participants completed the protocol (treatment groupn=12, control groupn=13). No adverse events related to the acupuncture protocol were observed. Compared to baseline values, the two groups did not significantly differ in any outcome measures at the end of the acupuncture protocol.Conclusions. CAIP-based acupuncture did not favorably modulate inflammatory or lipid parameters. Additional studies are warranted of CAIP-based protocols of different frequencies/durations.

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