• Korean Journal of Clinical Pharmacy
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• v.22 no.2
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• pp.131-136
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• 2012

Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

• The Journal of Advanced Prosthodontics
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• v.3 no.3
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• pp.161-165
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• 2011

PURPOSE. This randomized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the ${\beta}$-TCP bone graft material that contains ErhBMP-2. MATERIALS AND METHODS. This study involved 72 patients at the 3 study centers. The patients, who were divided into 2 groups: the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction. CT was taken before and 3 months after the transplantation and healing status was compared between the two groups. The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width. The paired t test was used to determine the significance of the changes (P<.05). RESULTS. Changes in alveolar bone height were $-1.087{\pm}1.413$ mm in the control group and $-.059{\pm}0.960$ mm in the experimental group (P<.01). At 25% extraction socket length [ESL], the changes were $0.006{\pm}1.149$ mm in the control group and $1.279{\pm}1.387$ mm in the experimental group. At 50% ESL, the changes were $0.542{\pm}1.157$ mm and $1.239{\pm}1.249$ mm, respectively (P<.01 for 25% ESL, and P<.05 for 50% ESL). During the experiment, no adverse reactions to the graft material were observed. CONCLUSION. ErhBMP-2 coated ${\beta}$-TCP/HA were found to be more effective in preserving alveolar bone than conventional ${\beta}$-TCP/HA alloplastic bone graft materials.

• Journal of Periodontal and Implant Science
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• v.53 no.4
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• pp.306-317
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• 2023

Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ² test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.4
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• pp.1-15
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• 2014

Objective : This study was carried out to analyze the quality and quantity of Clinical Trials that have been published in the journal of korean medical ophthalmology, otolaryngology, dermatology(JKOOD). Methods : We analyzed 25 clinical trials that published in JKOOD from 1988 to 2014. We excluded case reports, protocol and retrospective studies and classified searched papers into three categories; Randomized Clinical Trials(RCT), Non Randomized Clinical Trials(NRCT), Before After Study(BAS) by using study Design Algorithm for Medical literature of Intervention(DMAI). All articles were analyzed according to diagnosis, statistics program and intervention period. The bias of RCTs were evaluated by Cochrane Risk of Bias(RoB). Result : 1. The number of searched journals is 25 papers; 13 RCT, 2 NRCT, 10 BAS 2. Distribution of clinical trial; 'Atopic dermatitis' ranked the highest(44%) in disease, 'External application' raked the highest(71%) in treatment method. 3. 'allocation sequence' and 'prevention of allocated intervent to patients and therapists' are graded 'Low' but 'incomplete outcome date' and 'selective outcome' are graded 'Uncertain'. Conclusions : It is necessary to study more RCT. It will be helpful to study systematic reviews and meta analysis in JKOOD.

• The korean journal of orthodontics
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• v.47 no.1
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• pp.11-20
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• 2017

Objective: This randomized controlled trial aimed to compare the stability of mandibular arch orthodontic treatment outcomes between passive self-ligating and conventional systems during 6 months of retention. Methods: Forty-seven orthodontic patients with mild to moderate crowding malocclusions not requiring extraction were recruited based on inclusion criteria. Patients (mean age $21.58{\pm}2.94years$) were randomized into two groups to receive either passive self-ligating ($Damon^{(R)}$ 3MX, n = 23) or conventional system (Gemini MBT, n = 24) orthodontic treatment. Direct measurements of the final sample comprising 20 study models per group were performed using a digital caliper at the debonding stage, and 1 month, 3 months, and 6 months after debonding. Paired t-test, independent t-test, and non-parametric test were used for statistical analysis. Results: A significant increase (p < 0.01) in incisor irregularity was observed in both self-ligating and conventional system groups. A significant reduction (p < 0.01) in second interpremolar width was observed in both groups. Mandibular arch length decreased significantly (p = 0.001) in the conventional system group but not in the self-ligating system group. A similar pattern of stability was observed for intercanine width, first interpremolar width, intermolar width, and arch depth throughout the 6-month retention period after debonding. Comparison of incisor irregularity and arch dimension changes between self-ligating system and conventional system groups during the 6 months were non-significant. Conclusions: The stability of treatment outcomes for mild to moderate crowding malocclusions was similar between the self-ligating system and conventional system during the first 6 months of retention.

• The korean journal of orthodontics
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• v.51 no.5
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• pp.329-336
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• 2021

Objective: To compare the magnitude of external apical root resorption (EARR) 6 months after starting orthodontic treatment using orthodontic aligners (OAs) and fixed appliances (FAs). Methods: This parallel randomized clinical trial included 40 patients randomized into two groups: OA group (n = 20, 160 incisors) and FA group (n = 20, 160 incisors). For evaluation of the tooth length, periapical radiographs and standardized linear measurements of the maxillary and mandibular incisors were acquired before (T0) and 6 months after treatment initiation (T1). EARR was calculated through the difference in length between the two time points (T1-T0). Statistical comparisons were performed by means of using t-tests, chi-squared test and covariance analysis (a = 5%). Results: Rounding of the root apex was observed in both groups; the resorption involved 2.88% of the root length, so 97.12% of the tooth length remained intact. Intragroup comparisons between the two time points revealed a significant difference, with (T1-T0) ranging from -0.52 to -0.88 mm in the FA group and from -0.52 to -0.85 mm in the OA group. In the intergroup comparisons, only tooth #21 presented a statistically significant difference (OA: -0.52 ± 0.57 mm, FA: -0.86 ± 0.60 mm); however, the overall differences between groups were not clinically relevant, ranging from 0.03 to 0.35 mm. Conclusions: OA and FA treatment resulted in a similar degree of EARR in the maxillary and mandibular incisors at 6 months after treatment initiation. However, the amount of resorption was small and does not impair tooth longevity.

• Journal of Haehwa Medicine
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• v.15 no.1
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• pp.41-45
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• 2006

Aims: This overview summarizes the existing evidence on acupuncture for cancer-related pain. Methods: Literature searches were conducted in 7 databases. All clinical studies of acupuncture, electroacupuncture, ear acupuncture and transcutaneous electrical nerve stimulation (TENS) in cancer patients with the main outcome measure of pain were included. Results: Of the 8 studies included, one high quality randomized clinical trial (RCT) of ear acupuncture showed statistically significant pain relief in comparison with placebo ear acupuncture. All the other studies were either non-blinded (n = 2) or uncontrolled clinical trials (n = 5). Most investigations suffered from methodological flaws such as inadequate study design, poor reporting of results, small sample size and overestimation of the results. Conclusions: The current evidence does not support the use of acupuncture as an adjunctive analgesic method for cancer patients. Only one high quality RCT showed promising results thus warranting further investigation into this under-researched area.

• Korean Journal of Oriental Medicine
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• v.13 no.3
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• pp.97-103
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• 2007

The object of this study is to evaluate confounding effect of sleeping behavior on heart rate variability (HRV) in healthy volunteers during a randomized clinical trial. From 6 healthy volunteer, we acquired circadian electrocardiography(ECG) with a Holter monitoring device(DigiTrak Plus, Philips). The compatible analytical program, Zymed, was used for calculation of RR intervals of 24h ECG signal. Then, we generated HRV signals and calculated 9 HRV parameters in time domain and frequency domain for every 30 minute with Matlab 6.x software. We also encoded participants' activities as follows; stable condition(1), sleeping behavior(2), eating behavior(3), and undefined condition(4). Using SPSS 12.0, we tested if there was any difference between HRV parameters of day-time and night-time and between those of a subject in stable condition and in sleeping behavior. As a result, one of the most important parameter-LF/HF ratio, which indicates the autonomic balance between sympathetic and parasympathetic nervous systems, as same the other parameters, showed large inter-individual variations in circadian profiles. And, the mean LF/HF ratio of each participant was different between in stable condition and in sleeping behavior (p<.05). Consequently, the effect of sleeping behavior must be considered when one or more of HRV parameters, especially LF/HF ratio, are used as assessment index in clinical studies.

• Journal of Periodontal and Implant Science
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• v.44 no.6
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• pp.280-287
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• 2014

Purpose: The purpose of this randomized single-blind controlled trial was to elucidate the clinical and antimicrobial effects of daily phototherapy (PT) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Methods: The study was conducted from December 2013 to May 2014 at Ewha Womans University Mokdong Hospital, Seoul, Korea. Forty-one patients with mild to moderate chronic periodontitis were randomly divided into two therapeutic groups in a 1:1 ratio: SRP+PT and SRP (control) groups. All participants underwent full-mouth SRP. PT was performed thrice a day for a month by using electric toothbrushes with embedded light-emitting diodes. Plaque index, gingival index, probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing were assessed before (baseline) and four weeks after (follow-up) the treatment. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Parvimonas micra, Campylobacter rectus, Eikenella corrodens, Streptococcus mutans, and Streptococcus sobrinus levels were detected by a real-time polymerase chain reaction at the same points in time. Results: The clinical parameters improved in both the groups. At the follow-up assessment, PPD was significantly decreased in the SRP+PT group (P=0.00). Further, PPD and CAL showed significantly greater changes in the SRP+PT group than in the SRP group (PPD, P=0.03; CAL, P=0.04). P. gingivalis and T. forsythia levels decreased in this group, but no significant intergroup differences were noted. Conclusions: Adjunctive PT seems to have clinical benefits, but evidence of its antimicrobial effects is not sufficient. Long-term studies are necessary to develop the most effective PT protocol and compare the effectiveness of PT with and without exogenous photosensitizers.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.3
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.