• 제목/요약/키워드: Randomized Trial

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Influence of implant-abutment connection structure on peri-implant bone level in a second molar: A 1-year randomized controlled trial

  • Kim, Jin-Cheol;Lee, Jungwon;Kim, Sungtae;Koo, Ki-Tae;Kim, Hae-Young;Yeo, In-Sung Luke
    • The Journal of Advanced Prosthodontics
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    • 제11권3호
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    • pp.147-154
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    • 2019
  • PURPOSE. This study aimed to evaluate the effect of two different implant-abutment connection structures with identical implant design on peri-implant bone level. MATERIALS AND METHODS. This clinical study was a patient-blind randomized controlled trial following the CONSORT 2010 checklists. This trial was conducted in 24 patients recruited between March 2013 and July 2015. Implants with internal friction connection were compared to those with external hex connection. One implant for each patient was installed, replacing the second molar. Implant-supported crowns were delivered at four months after implant insertion. Standardized periapical radiographs were taken at prosthesis delivery (baseline), and one year after delivery. On the radiographs, distance from implant shoulder to first bone-to-implant contact (DIB) and peri-implant area were measured, which were the primary and secondary outcome, respectively. RESULTS. Eleven external and eleven internal implants were analyzed. Mean changes of DIB from baseline to 1-year postloading were 0.59 (0.95) mm for the external and 0.01 (0.68) mm for the internal connection. Although no significant differences were found between the two groups, medium effect size was found in DIB between the connections (Cohen's d = 0.67). CONCLUSION. Considering the effect size in DIB, this study suggested the possibility of the internal friction connection structure for more effective preservation of marginal bone.

Recruitment and enrollment in a randomized clinical trial of mandibular two-implant overdenture

  • Lee, Jeong-Yol;Kim, Min-Soo;Kim, Ha-Young;Shin, Sang-Wan
    • The Journal of Advanced Prosthodontics
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    • 제5권2호
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    • pp.204-208
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    • 2013
  • PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.

독일에서 수행된 대규모의 침 치료 임상연구 Acupuncture Randomized Trials와 the Acupuncture in Routine Care에 대한 고찰 (Review of the Acupuncture Randomized Trials(ART) and the Acupuncture in Routine Care(ARC): the Acupuncture Trials in Germany)

  • 한국인;윤주연;정진수;이승호;장인수
    • Journal of Acupuncture Research
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    • 제30권5호
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    • pp.117-123
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    • 2013
  • Objectives : The purpose is to review large-scale clinical researches, the acupuncture randomized trials(ART) and the acupuncture in routine care(ARC), concerning efficacy and effectiveness of acupuncture performed in Germany. Methods and Results : We have reviewed the studies that were searched by keyword 'acupuncture' as the title and'Witt CM' as one of the main authors in PubMed. Sixteen clinical reports focused on the ART and ARC studies were analyzed among all thirty six were searched. Six studies were related with the ART and eight were focused on the ARC, and other two were on both. Finally, across all researches except osteoarthritis of knee trials in the ART, compared the acupuncture group with the control were significantly improved. On the other hand, ARC showed that additional acupuncture plus routine care was more effective than routine care alone and the response to treatment of the non-randomized group did not differ the one of the randomized acupuncture group. Conclusions : The results may suggest that acupuncture treatment has obvious clinical effectiveness. These results are expected to inspire domestic research and clinical applications in Korea, and more rigorous research on the efficacy of acupuncture should be guaranteed.

Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

  • Lee, Hyun-Jong;Seo, Jung-Chul;Park, Sung-Hoon;Kwak, Min-Ah;Shin, Im Hee;Min, Bo-Mi;Cho, Min-Su;Roh, Woon-Seok;Jung, Jin-Yong
    • 대한약침학회지
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    • 제18권1호
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    • pp.79-85
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    • 2015
  • Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

만성 요통 환자의 침 치료 경험(2): 질적 연구 - 무작위 대조군 연구 피험자를 대상으로 (Acupuncture Experience in Patients with Chronic Low Back Pain(2): A Qualitative Study - Focused on Participants in Randomized Controlled Trial)

  • 김송이;이기병;이향숙;손행미;송미연;이혜정;박히준
    • Korean Journal of Acupuncture
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    • 제29권4호
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    • pp.581-597
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    • 2012
  • Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

화병에 대한 사암침 심포정격의 치료 효과 : 환자-평가자 눈가림, 무작위배정 대조군 임상시험 (The effects of Sa-am Acupuncture Simpojeongkyeok Treatment on Hwa-byung : Randomized, patient-assessor blind, placebo-controlled acupuncture, pilot clinical trial)

  • 최우진;이승기;손인봉;선승호
    • 동의신경정신과학회지
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    • 제22권2호
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    • pp.1-13
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    • 2011
  • Objectives : The purpose of this research is to examine the effects of Sa-am acupuncture Simpojeongkyeok treatment on Hwa-byung. Methods : The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collector and analyst were unaware of individuals which were receiving the treatment. Fifty volunteers were divided into a trial and a control group, each of which consisted of 25 subjects. The trial group was treated with Sa-am acupuncture Simpojeongkyeok, while needle insertion at non-acupoints was given to the control group. The Likert scale for major symptoms of Hwa-byung was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by of STAXI-K, STAI-K and BDI-K. Results : In the Likert scale comparison of major symptoms, total scores in both groups were decreased after treatment. However, a more significant decrease was found in those of trial group compared to those of the control group from a statistical perspective. The results measured by BDI scores also decreased significantly in the trial group after treatment. In comparison of STAXI and STAI scores, there were no significant differences found between the groups. Conclusions : The results suggest that Sa-am Acupuncture Simpojeongkyeok treatment is effective in the treatment of Hwa-byung.

화병환자의 불면증상에 대한 침치료 유효성 평가연구: 환자-평가자 눈가림, 무작위배정, 일반대조군 임상시험 (The Effects of Acupuncture Treatment on Hwa-byung patient's Insomnia: Patient-assessor blind, Randomized, Placebo-controlled Clinical trial)

  • 이고은;김남권;김향이;강형원
    • 동의신경정신과학회지
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    • 제23권1호
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    • pp.31-48
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    • 2012
  • Objectives: The purpose of this research is to examine the effects of acupuncture treatment on Hwa-byung patient's insomnia. Methods: The study was performed through a patient-assessor blind, randomized, placebo-controlled trial in which the volunteers, data collectors and analysts were unaware of individuals who were receiving the treatment. A total of thirty-seven volunteers were divided into 2 groups. 18 subjects were placed into a trial group and 19 subjects into a control group by a randomization table. The trial group was treated on bilateral Shigu, Ahnmyun, B62 (Shinmaek), and K6 (Chohae), while the control group was not given any other treatment. The ISI(Insomnia Severity Scale) was measured as the 1st evaluative instrument, and then a comparative analysis was conducted by comparing the results with those measured by a Likert scale for major symptoms of Hwa-byung, PSQI, Hwa-byung scale, BDI, STAI, and STAXI. Results: In the ISI, PSQI, and the Likert scale regarding major symptoms of Hwa-byung, Hwa-byung scale, BDI, and STAI, more significant decreases were found in those concerning the trial group compared to those of the control group from a statistical perspective. However, in the STAXI, regarding the trial group, there was no significant decrease compared to the control group. Conclusions: The results suggest that acupuncture treatment is effective in the treatment regarding Hwa-byung patients who suffer from insomnia.

Preliminary Study on Effectiveness of Dexamethasone-Soaked Gelatin Sponges for Reducing Pain after Lumbar Microdiscectomy : A Randomized Controlled Trial

  • Shin, Dong-Ah;Gong, Tae-Sik;Shin, Dong-Gyu;Kwon, Chang-Young;Kim, Hyoung-Ihl
    • Journal of Korean Neurosurgical Society
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    • 제39권1호
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    • pp.11-15
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    • 2006
  • Objective : A prospective, randomized, controlled clinical study is performed to verify the effectiveness of epidural dexamethasone-soaked gelatin sponges to reduce postoperative pain following lumbar microdiscectomy. Methods : Twenty-three patients (10 men and 13 women) undergoing lumbar microdiscectomy were included. Five pieces of gelatin sponge measuring $1{\times}1cm$ [Gelfoam; Pharmacia & Upjohn. Kalamazoo, MI, USA], soaked with either 5mg dexamethasone or an equal amount [2mL] of saline, were left on the decompressed nerve root after unilateral hemilami-nectomy, flavectomy and discectomy. Results : Subjective visual analog scale[VAS] scores of leg pain in the dexamethasone group on the first, third and first postoperative days [2.5, 2.5, 1.7, respectively] were significantly lower than in the control group [5.0, 4.8, 3.6][P<0.05]. No side effects related to the dexamethasone-soaked gelatin sponges were observed. Conclusion : The intraoperative application of dexamethasone-soaked gelatin sponges during lumber microdiscetomy can provide effective-postoperative analgesia without complications.

감기에 대한 연교패독산의 유효성 평가를 위한 community-based 이중맹검 위약 대조군 연구 (Effectiveness of a Yeonkyopaedok-san Extract in the Treatment of The Common Cold : Results of a Community-based, Double Blind, Randomized Placebo Controlled Trial)

  • 배한호;강위창;박양춘
    • 동의생리병리학회지
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    • 제22권1호
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    • pp.234-245
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    • 2008
  • Yeonkyopaedok-san(YPS) extract is widely used to treat the common cold. The purpose of this study was to evaluate the efficacy of YPS on the common cold. Two hundred Patients with common colds of recent onset were randomized to the double blind, placebo-controlled study. They received 800 mg YPS extract or placebo in capsules, orally dissolved 3 times a day for 7 days. The total symptom score was assessed by the physician, using a 5-point scale on start and finish. Resolution of cold symptoms based on subjective daily symptoms. Total symptom score was significantly decreased in YPS groups in comparison to that in placebo group (p=0.027). Headache (p=0.012), loss of appetite (p=0.037), eyeball discomfort (p=0.002) were more affected. Time to resolution of cold symptoms did not show significant effect (p=0.592). Adverse effects were less in the YPS group than placebo group (2% vs 3%). In this community-based, randomized controlled trial, YPS were effective in treating cold symptoms in college students.

좌섬요통(挫閃腰痛)에 있어 봉약침(蜂藥鍼)의 효과(效果)에 대한 연구(硏究)(A Randomized Controlled Trial; Double Blinding) (The Effectiveness of Bee Venom Acupuncture Therapy on the Treatment of Sprain of L-spine(A Randomized Controlled Trial; Double Blinding))

  • 김경태;송호섭
    • Journal of Acupuncture Research
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    • 제22권4호
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    • pp.113-120
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    • 2005
  • objectives : This study was to evaluate the effectiveness of Bee Venom acupuncture therapy for sprain of L -spine. Methods : A randomized double blinding study of bee venom acupuncture therapy was conducted on sprain of L-spine. We divided sprain of L-spine patient into 2 groups: one group with both acupuncture and saline acupuncture therapy, and another group with both acupuncture and bee venom acupuncture therapy. To estimate the efficacy of treatment that applied for two groups, we used visual analog scale(VAS) and oswestry disability index(ODI). We compared the VAS and ODI score of two groups statistically. Results : 1. As a result of evaluation by using visual analog scale(VAS) and oswestry disability index(ODI), treatment score after 5 days was marked more higher than score before treatment and treatment score after 10 days treatment was more higher than treatment score after 5 days on each groups. 2. After 10 days treatment, acupuncture and bee venom acupuncture therapy group had significant result on visual analog scale(VAS) and oswestry disability index(ODI) compared with acupuncture and saline acupuncture therapy group. Conclusion : Bee Venom acupuncture therapy can be used with acupuncture therapy for highly effective treatment for sprain of L-spine.

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