• Title/Summary/Keyword: randomized clinical trial

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The Effect of Virtual Reality Based Rehabilitation Program on Balance of Patient with Stroke: A Meta-analysis of Studies in Korea (가상현실기반 재활프로그램이 뇌졸중환자의 균형에 미치는 영향 : 국내연구에 대한 메타분석)

  • Roh, Jung-suk
    • Journal of Korean Physical Therapy Science
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    • v.24 no.1
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    • pp.59-68
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    • 2017
  • Purpose : The aims of this study was to conduct a systematic literature review with meta-analysis to investigate the effect of virtual reality based rehabilitation program on balance of patient with stroke in Korean studies. Method : The studies for analysis were searched in electronic databases(Research Information Sharing Service; RISS, Korean Studies Information Service; KISS, DBpia, e-articles, National Assembly Library). The key words for search were 'virtual reality', 'stroke', and 'balance' and only randomized controlled trials and clinical controlled trials were included. Of 40 studies identified in the search, 20 studies met the criteria of this study and included in this meta-analysis. Result : The results were as follows: 1) The overall effect size of virtual reality based rehabilitation program was 0.557(95% critical interval; 0.340~0.774). 2) In the analysis of sub-categorical variables, effect size was as follows; the commercial game type(0.621) > virtual environment type(0.335); the dynamic balance measurement(0.750) > static balance measurement(0.226); randomized controlled trial(0.653) > clinical controlled trial(0.275); and thesis type(0.706) > article of journal type(0.339). 3) In the analysis of sub-continuous variables, as time of program(per session) increased, the balance increased(p<0.05). Conclusion : The results of this study showed that virtual reality based rehabilitation program moderately improves the balance of stroke patient. Further studies are recommended to investigate the effect of sub-variables related to virtual reality programs on motor functions of patient with stroke.

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The effect of otago exercise-based fall prevention education activities on balance, fall efficacy and activities of daily living in the subacute stroke patients: A randomized controlled clinical trial (오타고운동 기반 낙상예방교육활동이 아급성 뇌졸중 환자의 균형, 낙상 효능감 및 일상생활동작능력에 미치는 영향: 무작위 대조군 임상 연구)

  • Yoon, Hyun Sik;Han, Kyu Bum;Oh, Seung In;Lee, Da Bee;Song, Ha Hee;Song, Jeong Eun;Cha, Young Joo
    • Journal of Korean Physical Therapy Science
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    • v.27 no.1
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    • pp.1-8
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    • 2020
  • Background: This study analysed the effect of the fall prevention education activities on balance, fall efficacy, activities of daily living (ADL) of sub-acute stroke patients. Design: Randomized controlled trial. Methods: The subjects of the study were 24 subacute patients, who have onset period of less than 6 months. They are randomly allocated in the conventional therapy group (n=12) and fall prevention education group (n=12) and observed with frequency for 5 times a week for four weeks. Measuring took place before and after the experiment leading to following results of the Fall efficacy scale (FES), Berg balance scale (BBS) and Functional Independence Measure (FIM). Results: FES, BBS and FIM score was significantly greater in the post-test than in the pre-test in both groups (p<0.01). Independent t-test confirmed that the fall prevention education group showed much greater improvement change in the FES, BBS and FIM score than conventional therapy group (p<0.05). Conclusion: The present study demonstrated the importance of clinical contribution of the fall prevention education in the individuals with subacute stroke patients to the balance, fall efficacy and ADL following the stroke rehabilitation.

A randomized clinical trial to evaluate and compare the efficacy of triphala mouthwash with 0.2% chlorhexidine in hospitalized patients with periodontal diseases

  • Naiktari, Ritam S.;Gaonkar, Pratima;Gurav, Abhijit N.;Khiste, Sujeet V.
    • Journal of Periodontal and Implant Science
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    • v.44 no.3
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    • pp.134-140
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    • 2014
  • Purpose: Triphala is a combination of three medicinal plants, extensively used in Ayurveda since ancient times. Triphala mouthwash is used in the treatment of periodontal diseases because of its antimicrobial and antioxidant properties. The aim of this study is to compare the efficacy of triphala mouthwash with 0.2% chlorhexidine in hospitalized periodontal disease patients. Methods: In this double-blind, randomized, multicenter clinical trial, 120 patients were equally divided into three groups. Patients in group A were advised to rinse their mouths with 10 mL of distilled water, group B with 0.2% chlorhexidine, and group C with triphala mouthwash for 1 minute twice daily for two weeks. The plaque index (PI) and the gingival index (GI) were recorded on the first and the fifteenth day. Results: There was no significant difference when the efficacy of triphala was compared with 0.2% chlorhexidine in hospitalized patients with periodontal disease. However, a statistically significant difference was observed in PI and GI when both group B and group C were compared with group A and also within groups B and C, after 15 days (P<0.05). Conclusions: The triphala mouthwash (herbal) is an effective antiplaque agent like 0.2% chlorhexidine. It is significantly useful in reducing plaque accumulation and gingival inflammation, thereby controlling periodontal diseases in every patient. It is also cost effective, easily available, and well tolerable with no reported side effects.

Post-operative analgesia of 2% lignocaine with or without magnesium sulfate for inferior alveolar nerve block in symptomatic mandibular molars - a randomized double blind controlled clinical trial

  • Chandrasekaran, Charanya;Vijay, Amirtharaj L;Sekar, Mahalaxmi;Mary, Nancy S
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.3
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    • pp.147-154
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    • 2020
  • Background: Single inferior alveolar nerve block is ineffective in achieving adequate pulpal anesthesia in 30-80% of patients due to anatomical variations, local tissue pH, central sensitization, and several factors. Various supplementary techniques and combination of adjuvants with lignocaine are used to overcome these failures. Magnesium sulfate (MgSO4), one such adjuvant, acts at the N-methyl-D-aspartate glutamate receptor resulting in effective anesthesia. The aim of this prospective, randomized, double-blind, clinical controlled trial was to evaluate the onset, anesthetic efficacy, duration and post-operative analgesia of 2% lignocaine with and without the addition of MgSO4 in patients with symptomatic irreversible pulpitis and apical periodontitis. Methods: Fourty-two patients were randomly divided into three groups: 2% lignocaine (group 1) and 2% lignocaine with MgSO4 (75 mg) and (150 mg) in groups 2 and 3, respectively. Pre-operative vitals and Heft Parker-Visual Analogue Scale (HP-VAS) pain scores were recorded. The onset of anesthesia, anesthetic efficacy, and duration of anesthesia were evaluated post administration of the local anesthetic solution. The post-operative analgesia was examined at intervals of 2, 6, 12, 24, and 48 h. Results: Administration of 150 mg MgSO4 hastens the onset of anesthesia (1.29 min) and produces better anesthetic efficacy (3.29 HP-VAS) compared to group 2 (2.07 min and 9.14 HP-VAS) and group 1 (3.29 min and 35.79 HP-VAS), respectively. The duration of anesthesia was significantly higher in group 3 (247.07 min) compared to that of groups 2 and 1 (190 min and 110.21 min) with P < 0.05. Conclusion: Combining 75 mg or 150 mg of MgSO4 with lignocaine is more effective than 2% lignocaine and 75 mg of MgSO4 is adequate for endodontic procedures.

Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

  • Hajizadeh, Hila;Nemati-Karimooy, Atefeh;Majidinia, Sara;Moeintaghavi, Amir;Ghavamnasiri, Marjaneh
    • Restorative Dentistry and Endodontics
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    • v.42 no.3
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    • pp.168-175
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    • 2017
  • Objectives: This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS) after periodontal surgery. Materials and Methods: Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil $S^3$ Bond (Kuraray Dental), G2: Gluma Desensitizer (Heraeus Kulzer), and G3: placebo (water). The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0), 1 day after treatment (T1), after 1 week (T2), and 1 month (T3) according to visual analog scale (VAS). Results: Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions: Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil $S^3$ Bond can have some benefits.

Chewing gum as a non-pharmacological alternative for orthodontic pain relief: A randomized clinical trial using an intention-to-treat analysis

  • da Silva Santos, Diego Junior;Capelli, Jonas Jr.
    • The korean journal of orthodontics
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    • v.51 no.5
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    • pp.346-354
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    • 2021
  • Objective: To compare the effectiveness of ibuprofen, acetaminophen, and chewing gum for orthodontic pain relief and to assess if chewing gum can be a non-pharmacological alternative for orthodontic pain relief. Methods: The study enrolled 106 patients of both sexes, aged ≥ 12 years, with body weight > 50 kg, and mild-to-moderate dental crowding in the upper arch. After randomization and allocation concealment, the intervention groups were either administered with ibuprofen (400 mg) or acetaminophen (500 mg) or chewed sugar-free chewing gum immediately after initial archwire placement and every 6 hours for 1 week if the pain persisted. The control group did not receive any pain relief. The pain was assessed on a 100-mm visual analog scale at rest and while biting down at T1 (2 hours), T2 (24 hours), T3 (2 days), T4 (3 days), T5 (7 days), and T6 (21 days). Statistical analyses were performed using the Kruskal-Wallis and post-hoc Mann-Whitney U tests (α = 0.05). Results: The chewing gum group experienced more pain relief than the ibuprofen group at while biting down at T3 (p = 0.04) and at rest at T4 (p < 0.001). The chewing gum group reported more pain relief than the acetaminophen and control groups while biting down at T3 (p = 0.03 and p = 0.0006, respectively) and T4 (both p < 0.001). Conclusions: Chewing gum can be a non-pharmacological alternative for orthodontic pain relief at 2 and 3 days after initial archwire placement.

Effectiveness of the novel impression tray "cleftray" for infants with cleft lip and palate: a randomized controlled clinical trial

  • Kalaskar, Ritesh;Bhaje, Priyanka;Balasubramanian, Shruti;Kalaskar, Ashita
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.47 no.2
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    • pp.82-90
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    • 2021
  • Objectives: Cleft lip and palate (CLP) is one of the most common congenital deformities with worldwide prevalence. It causes a range of issues for infants that mainly involve difficulty in feeding due to abnormal oronasal communication. For this purpose, feeding plates are provided to infants to act as an artificial palate to aid in feeding. The most crucial procedure in fabrication of a feeding plate is creation of the impression using the traditional finger technique or impression trays. This preliminary research aims to compare the effectiveness of novel impression trays with that of the traditional finger technique for recording impressions of infants with CLP. Materials and Methods: This randomized controlled trial was conducted among 30 infants who were divided into two groups based on the method of obtaining impressions: Group I, finger technique; Group II, specialized acrylic tray (cleftray). Results: Use of cleftray required less impression time, a reduced amount of material, no incidence of cyanosis/choking in infants, and lower anxiety among doctors compared to the traditional method. Additionally, there was no distortion of cleft impressions, recorded maxillary tuberosity, or other fine details. Therefore, the novel impression tray (cleftray) exhibited superior outcomes in all the parameters compared to the finger technique. Conclusion: Within the limitations of this study, we conclude that impression trays are superior to the traditional finger, spoon, or ice cream stick methods of creating impressions of CLP. However, it is necessary to conduct more clinical trials on a larger population based on other parameters to compare the effectiveness of the two techniques to draw definitive conclusions.

Effect of Korean Red Ginseng in individuals exposed to high stress levels: a 6-week, double-blind, randomized, placebo-controlled trial

  • Baek, Ji Hyun;Heo, Jung-Yoon;Fava, Maurizio;Mischoulon, David;Choi, Kwan Woo;Na, Eun Jin;Cho, Hana;Jeon, Hong Jin
    • Journal of Ginseng Research
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    • v.43 no.3
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    • pp.402-407
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    • 2019
  • Background: To investigate the neurobiological evidence supporting the adaptogenic effects of Korean Red Ginseng in reducing the harmful consequences of stress using a double-blind, placebo-controlled trial. Method: Sixty-three subjects with high stress levels were randomized to receive an orally administered, double-blind, 6-week treatment with Korean Red Ginseng (n = 32) or placebo (n = 31). All participants underwent a comprehensive psychological evaluation using Beck Depression Inventory and Stress Response Inventory, cognitive evaluation using the continuous performance test, biological evaluation by measuring blood levels of lipids, catecholamines, inflammation markers, and heart rate variability at baseline and after 6 weeks. Results: At baseline, both groups showed no significant differences in age, sex, years of education, Beck Depression Inventory, and Stress Response Inventory. After 6 weeks, triglyceride levels were significantly increased within the normal limit in the Korean Red Ginseng group (F = 4.11, p = 0.048), and the epinephrine level was decreased in this group (F = 4,35, p = 0.043). The triglyceride increase was significantly associated with epinephrine decrease (B = 0.087, p = 0.041), suggesting that Korean Red Ginseng may stabilize the sympathetic nervous system. In addition, we detected a significant group by time effect in the visually controlled continuous performance test, suggesting positive effects of Korean Red Ginseng on cognition. Conclusion: Korean Red Ginseng might help to stabilize the sympathetic nervous system and improve cognition in individuals with high stress.

Effect of Synbiotic on the Treatment of Jaundice in Full Term Neonates: A Randomized Clinical Trial

  • Ahmadipour, Shokoufeh;Baharvand, Parastoo;Rahmani, Parisa;Hasanvand, Amin;Mohsenzadeh, Azam
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.22 no.5
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    • pp.453-459
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    • 2019
  • Purpose: Jaundice accounts for most hospital admissions in the neonatal period. Nowadays, in addition to phototherapy, other auxiliary methods are used to reduce jaundice and the length of hospitalization. This study aimed to investigate the effect of probiotics on the treatment of hyper-bilirubinemia in full-term neonates. Methods: In this randomized clinical trial, 83 full-term neonates, who were admitted to the hospital to receive phototherapy in the first 6 months of 2015, were randomly divided into two groups: synbiotic (SG, n=40) and control (CG, n=43). Both groups received phototherapy but the SG also received 5 drops/day of synbiotics. Serum bilirubin, urine, stool, feeding frequency, and weight were measured daily until hospital discharge. A p-value<0.05 was considered statistically significant. Results: The mean total serum bilirubin in the SG was lower than that in the CG ($9.38{\pm}2.37$ and $11.17{\pm}2.60mg/dL$, respectively). The urine and stool frequency in the SG was significantly higher than that in the CG (p<0.05). The duration of hospitalization in the SG was shorter than that in the CG. Conclusion: Use of synbiotics as an adjuvant therapy had a significant treatment effect on jaundice in full-term neonates. Further studies including larger samples with long follow-up periods are essential to confirm the benefits of routine use of synbiotics in neonatal patients with jaundice.

Effectiveness of anchorage with temporary anchorage devices during anterior maxillary tooth retraction: A randomized clinical trial

  • Barthelemi, Stephane;Desoutter, Alban;Souare, Fatoumata;Cuisinier, Frederic
    • The korean journal of orthodontics
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    • v.49 no.5
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    • pp.279-285
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    • 2019
  • Objective: This study evaluated the efficiency of anchorage provided by temporary anchorage devices (TADs) in maxillary bicuspid extraction cases during retraction of the anterior teeth using a fixed appliance. Methods: Patients aged 12 to 50 years with malocclusion for which bilateral first or second maxillary bicuspid extractions were indicated were included in the study and randomly allocated to the TAD or control groups. Retraction of the anterior teeth was achieved using skeletal anchorage in the TAD group and conventional dental anchorage in the control group. A computed tomography (CT) scan was performed after alignment of teeth, and a second CT scan was performed at the end of extraction space closure in both groups. A three-dimensional superimposition was performed to visualize and quantify the maxillary first molar movement during the retraction phase, which was the primary outcome, and the stability of TAD movement, which served as the secondary outcome. Results: Thirty-four patients (17 in each group) underwent the final analysis. The two groups showed a significant difference in the movement of the first maxillary molars, with less significant anchorage loss in the TAD group than that in the control group. In addition, TAD movement showed only a slight mesial movement on the labial side. On the palatal side, the mesial TAD movement was greater. Conclusions: In comparison with conventional dental anchorage, TADs can be considered an efficient source of anchorage during retraction of maxillary anterior teeth. TADs remain stable when correctly placed in the bone during the anterior tooth retraction phase.