• Title/Summary/Keyword: Quality of clinical trial

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Phenomenological study on the problem-based learning experience of clinical dental hygiene among students in dental hygiene (치위생학과 학생의 임상치위생학 교과목 문제중심학습 경험에 관한 현상학적 연구)

  • Choi, Jin-Sun;Bae, Soo-Myoung;Shin, Sun-Jung;Shin, Bo-Mi;Lee, Hyo-Jin
    • Journal of Korean society of Dental Hygiene
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    • v.22 no.5
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    • pp.451-459
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    • 2022
  • Objectives: This study aimed to provide useful basic data for improving the quality of problem-based learning (PBL) to improve integrated thinking and problem-solving skills in clinical dental hygiene through in-depth exploration of the experiences of dental hygiene students trained in PBL modules. Methods: A total of nine participants were selected based on the grade distribution of clinical dental hygiene. Three participants each were from the upper, middle, and lower groups. A focus group interview (FGI) was conducted using a developed questionnaire. All contents of the recorded FGI were used to draw the main results while maintaining the core contents Results: The themes derived through the FGI were confirmed by 'advantages of PBL', 'competencies developed through PBL', 'teamwork experienced in PBL', 'required competencies for PBL team activities', 'differences in contribution among team members', 'satisfaction with PBL', 'improvements to PBL', and 'trial and error experienced in PBL'. Conclusions: The PBL was a useful for improving the integrated thinking and problem-solving skills of dental hygiene students. Moreover, this study provides useful basic data for the qualitative improvement of the PBL.

Single-session associative protocol for dentin hypersensitivity management: a 1-year randomized, blinded clinical study

  • Thayna Carolina Zeni;Poliana Maria de Faveri Cardoso;Rafael da Silva Vanolli;Marcio Jose Mendonca;Julio Katuhide Ueda;Veridiana Camilotti
    • Restorative Dentistry and Endodontics
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    • v.49 no.2
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    • pp.15.1-15.11
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    • 2024
  • Objectives: This study aimed to establish a single-session associative protocol for nonrestorative management of dentin hypersensitivity (DH). Materials and Methods: Twenty-four individuals with DH and a minimum sensitivity level of 4 on the visual analog scale (VAS) were selected. The study was conducted in a split-mouth design, with each participant (n = 20) having at least 1 affected tooth in all quadrants. The management protocols consisted of control group: universal adhesive, Neural Desensitizing Protocol group: 5% potassium nitrate, Mixed Desensitizing Protocol (PAM) group: 5% sodium fluoride and 5% potassium nitrate, Remineralizing Desensitizing Protocol (PDR) group: surface-partially reacted glass technology photopolymerizable varnish. Evaluations were performed immediately after application, at 1 week, 1 month, 2 months, and 12 months using the VAS sensitivity test. Results: The scores were subjected to statistical analysis using the Friedman test (p < 0.05), Durbin-Conover test (p < 0.05), and Wilcoxon test (p < 0.05). At the 12-month evaluation, all groups showed statistically significant differences compared to the initial assessment. For the evaluation after 12 months, there was a statistically significant difference between the PAM group, the control group, and the PDR group. Conclusions: It can be concluded that all groups were effective in controlling DH, but there were significant results in the control group and PDR group. The clinical relevance of this study is to demonstrate that the application of single-session desensitizing protocols can be effective in controlling DH for up to 12 months.

Interim Report about The Comparative Clinical Study of Efficacy of Gamisoyo-san(Jiaweixiaoyaosan) on Anxiety of Generalized Anxiety disorder (범불안장애의 불안증상에 대한 가미소요산의 제형별 효능 비교 임상연구의 중간보고)

  • Lim, Jung-Hwa;Seo, Bok-Nam;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.3
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    • pp.29-44
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    • 2010
  • Objectives : The purpose of this research is to examine the efficacy of Gamisoyosan on anxiety of generalized anxiety disorder according to dosage form. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Gamisoyosan simple extract mixture or Gamisoyosan compound extract or controlled medication for major symptoms of generalized anxiety disorder. As preparatory research, Hamilton rating Scale for Anxiety(HAM-A) was measured as the 1st evaluative instrument, and Korean State-Trait Anxiety Inventory(STAI-K), Penn State Worry Questionnaire(PSWQ) Korean Beck's Depression Inventory (BDI-K), Symptom Checklist-90-Revised(SCL-90R), WHO Quality of Life Abbreviated(WHOQOL-BREF) and Heart Rate Variability(HRV) were also measured as the 2nd evaluative instrument at the before treatment. Results : Demographic characteristics showed that there are Clinical characteristics-vital signs are within the normal range. The characteristics of disease-chief complaint, pattern Identification and etiological factor of the highest frequency number were worry, heart deficiency with timidity(心膽虛怯), family matters. The average period of disease in subjects is 6.31years. The results of Chest PA, EKG and clinicopathologic examination are within the reference range. The Scores of HAM-A, STAI-K, PSWQ were measured above the cutoff point. There are significant positive correlations among HAM-A, STAI-K, BDI-K and among HAM-A, STAI-K, PSWQ. There are no significant correlations between PSWQ and BDI-K. Conclusions : We considered that selection of subjects in this research is appropriately accomplished And this methodology is expected to be applied to the subsequent research. And also, we hope to make up for this study through various study and discussion.

Baduanjin Exercise for Shoulder Pain: A Systematic Review (견관절 통증에 대한 팔단금 운동의 효과: 체계적 문헌 고찰)

  • Kim, Hyun-Tae;Lee, Sang-Hyun;Park, Sun-Young;Heo, In;Hwang, Man-Suk;Shin, Byung-Cheul;Hwang, Eui-Hyoung
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.15 no.1
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    • pp.89-100
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    • 2020
  • Objectives : This study aimed to verify the clinical effectiveness of Baduanjin for shoulder pain. Methods : We searched 10 electronic databases (PubMed, EMBASE, Cochrane Library, CAJ, KISS, KISTI, KMBASE, RISS, NDSL, and OASIS) up to May 2020. We included randomized controlled trials (RCTs) using Baduanjin for shoulder pain. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : As a result of the search, a total of 6 RCTs were eligible for analysis. Of these 6 studies, one applied Baduanjin alone and 5 cases used Baduanjin in combination with other treatments, such as acupuncture or electroacupuncture. Except for 2 studies, descriptive analysis was performed without meta-analysis due to the high level of heterogeneity between studies. A high risk of bias was observed in all studies. Conclusions : When considering the results of the included papers, there was limited information derived on the therapeutic effect of using Baduanjin as a single intervention, but the results showed significant effectiveness when Baduanjin was combined with other oriental interventions, such as acupuncture and electroacupuncture, in the clinical field. Although all RCTs included in the analysis were biased to CAJ and the number was limited, this study was conducted in accordance with the methodological process of systematic literature reviews and revealed the clinical effects of Baduanjin on shoulder pain.

Comparison of clinical efficacy of ropivacaine and lignocaine with adrenaline for implant surgery anesthesia: a split-mouth randomized controlled clinical trial

  • Kalath, Remya Nath;Kulal, Rithesh;Gopinath, Sharika
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.4
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    • pp.337-344
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    • 2021
  • Background: The primary indication for using long-acting anesthetics in dentistry is extensive dental procedures that require pulpal anesthesia beyond 90 min and management of postoperative pain. Ropivacaine is an amide local anesthetic that is available at various concentrations with inherent vasoconstrictive properties at low concentrations. Ropivacaine has a 75% greater margin of safety than bupivacaine. Ropivacaine can be a good alternative to bupivacaine as a local anesthetic in dental implant surgery as it provides a longer duration of both pulpal and soft tissue anesthesia after mandibular nerve block and lowers CNS and cardiovascular toxicity. This study aimed to evaluate and compare the clinical efficacy of ropivacaine and lignocaine for implant surgery anesthesia. Methods: Fifteen patients with bilateral edentulous sites indicated for implant placement were recruited for this study. Patients aged 20-60 years of both sexes were randomly recruited. Thirty implant placements were performed in the test and control groups using ropivacaine and lignocaine with adrenaline as local anesthetics, respectively. Results: The results were analyzed statistically. The duration of anesthesia was significantly higher in the test group than in the control group. Ropivacaine was found to be superior to lignocaine in terms of the quality of anesthesia. The comparison of mean visual analog scale scores showed ropivacaine to have better anesthetic and analgesic effects than the control group. Conclusion: Ropivacaine 0.75% provides a significantly longer duration of anesthesia than lignocaine 2% with adrenaline. Ropivacaine 0.75% decreased intraoperative and postoperative analgesia compared to lignocaine 2% with adrenaline. Hence, ropivacaine 0.75% can be used as an alternative to lignocaine in implant surgeries and other intraoral surgical procedures that require a longer duration of anesthesia and analgesia.

Development of Clinical Protocol for Acquisition of Change of Radial Pulse Wave Signal in the Cold-Heat Intervention: Explanatory, Randomized, 2×2 cross-over design (냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발)

  • Yu, Hana;Kim, Jihye;Ku, Boncho;Kim, Hyunho;Jeon, Youngju
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.19 no.2
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    • pp.91-100
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    • 2015
  • Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.

Effect of Sihogayonggolmoryeo-Tang on Hwa-byung: A Multicenter, Randomized, Double-Blinded, Placebo-Control Trial

  • Choi, Woo-Chang;Lee, Hun-Soo;Kim, Ju-Yeon;Kang, Wee-Chang;Park, Yang-Chun;Kim, Geun-Woo;Kim, Jong-Woo;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.31 no.3
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    • pp.135-147
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    • 2020
  • Objectives: Hwa-byung is a mental illness. It is also known as a Korean culture-related syndrome. In traditional Korean medicine, Sihogayonggolmoryeo-tang is used to treat Hwa-byung related neuropsychiatric symptoms. The purpose of this research was to examine the effect of Sihogayonggolmoryeo-tang on Hwa-byung. Methods: A multicenter, randomized, double-blinded, placebo-controlled study was performed for 160 patients with Hwa-byung. Patients were divided into a Sihogayonggolmoryeo-tang group and a placebo group. Treatment period was 8 weeks. Hamilton Rating Scale for Anxiety (HAM-A), Likert scale for major symptoms of Hwa-byung, Hwa-byung Scale (HBS), Korean Beck Depression Inventory (K-BDI), Korean State-Trait Anxiety Inventory (K-STAI), Korean State-Trait Anger Expression Inventory (K-STAXI), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were used to evaluate the effect of Sihogayonggolmoryeo-tang on Hwa-byung. We also used an Instrument of Pattern Identification for Hwa-Byung to evaluate different responses for six patterns of patients. Results: Scores of all the measurements improved significantly for each group, showing no significant differences between the two groups. In the case of deficiency of both Qi and blood pattern, the Sihogayonggolmoryeo-tang group showed a significant decrease in the HAM-A score compared to the placebo group. Conclusions: The effect of Sihogayonggolmoryeo-tang on Hwa-byung did not exceed that of the placebo. Further studies involving more elaborate pattern identification are needed.

A Literature Study of Topical Application of Chinese Herbal Medicine for Allergic Rhinitis (국소한약외용제의 알레르기성 비염 치료 효과에 대한 문헌 고찰)

  • Bang, Mi Ran;Kim, Jang Hyun;Min, Sang Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.3
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    • pp.52-60
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    • 2016
  • Objectives The purpose of this study is to analyze studies about the effects of topical application of Chinese herbal medicine for allergic rhinitis within randomized controlled trials (RCT). Methods The search database includes KJTK (Korean Traditional Knowledge Portal), OASIS (Oriental Medicine Advanced Searching Integrated system), CNKI (China National Knowledge Infrastructure), PubMed, and EMBASE. We used the following key search terms: "allergic rhinitis", "traditional Chinese medicine", "traditional Korean medicine", "Chinese herbal medicine", "randomized controlled trial", "clinical study", "nasal spray", and "nasal drop" Results Five studies were selected for analysis. Three studies used nasal spray of Chinese herbal medicine and two studies used nasal drops of Chinese herbal medicine for the intervention. Frequently used herbs were Magnoliae Flos (辛夷), Scutellariae Radix (黃芩), Coptidis Rhizoma (黃連), and Astragali Radix (黃芪). For the outcome measures, studies used symptom score, questionnaire of Quality of Life, nasal airway resistance, or laboratory studies. From all 5 studies, it has been shown that topical application of Chinese herbal medicine was effective for improving symptoms of allergic rhinitis. Two out of five studies showed statistical difference between study group and control group. Conclusions This study shows that topical application of Chinese herbal medicine can improve symptoms of allergic rhinitis. Well-designed RCT studies with low risk of bias and studies with outcome measures for assessing the immunomodulatory effects are necessary to confirm these findings.

Acupuncture for Subacute and Chronic Post-thoracotomy Pain in Patients with Traumatic Multiple Rib Fractures: A Study Protocol for a Randomised-controlled, Two-arm, Parallel Design, Pilot Trial

  • Kim, Kun Hyung;Cho, Hyun Min;Lee, Chan Kyu;Seok, JunePill;Kim, Seon Hee;Kim, Jung-Eun;Shin, Yu Kyung;Kim, Min Kyung
    • Journal of Acupuncture Research
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    • v.35 no.2
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    • pp.95-100
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    • 2018
  • Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial

  • Juthong, Siwasak;Panyarath, Pattaraporn
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.1
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    • pp.67-73
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    • 2022
  • Background: Bronchiectasis patients with neutrophilic airway inflammation develop symptoms of chronic cough, sputum production, and recurrent exacerbations. Roflumilast has anti-inflammatory actions via decreased neutrophilic airway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated. Methods: We conducted a double-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV1) and St. George's Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 ㎍ of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results: Forty bronchiectasis patients who had experienced exacerbations were screened. Thirty patients completed the study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbations were 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Prebronchodilator FEV1 increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L in the placebo group, but the difference was not significant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebo groups. Roflumilast had significant side effects, including loss of appetite and headache. Conclusion: Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV1 tended to improve more in the roflumilast group than in the placebo group.