• Title/Summary/Keyword: Clinical Trial Design

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3D analysis of soft tissue around implant after flap folding suture (Flap folding suture를 활용한 판막의 고정에 따른 임플란트 주변 연조직 3차원 부피 변화 관찰)

  • Jung, Sae-Young;Kang, Dae-Young;Shin, Hyun-Seung;Park, Jung-Chul
    • Journal of Dental Rehabilitation and Applied Science
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    • v.37 no.3
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    • pp.130-137
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    • 2021
  • Purpose: The various suture techniques can be utilized in order to maximize the keratinized tissue healing around dental implants. The aim of this study is to compare the soft tissue healing pattern between two different suture techniques after implant placement. Materials and Methods: 15 patients with 18 implants were enrolled in this study. Simple implant placement without any additional bone graft was performed. Two different suture techniques were used to tug in the mobilized flap near the healing abutment after paramarginal flap design. Digital intraoral scan was performed at baseline, post-operation, stitch out, and 3 months after operation. The scan data were aligned using multiple points such as cusp, fossa of adjacent teeth, and/or healing abutment. After subtracting scan data at baseline with other time-point results, closed space indicating volume increment of peri-implant mucosa was selected. The volume of the close space was measured in mm3. The volume between two suture techniques at three time-points was compared using nonparametric rank-based analysis. Results: Healing was uneventful in both groups. Both suture technique groups showed increased soft tissue volume immediately after surgery. The amount of volume increment significantly decreased after 3 months (P < 0.001). Flap folding suture group showed higher median of volume increment than interrupted suture group after 3 months without any statistical significance (P > 0.05). Conclusion: After paramarginal flap reflection, the raised flaps stabilized by flap folding suture showed relatively higher volume maintenance after 3-month healing period. However, further studies are warranted.

Clinical Efficacy of Erdosteine in Patients with Acute or Chronic Bronchitis -A Randomized, Double Blind, Comparative Study vs. Ambroxol- (급.만성 기관지염 환자에서 엘도스$^{(R)}$(Erdosteine)의 임상효과 -염산 암브록솔과의 무작위 이중맹검 비교시험-)

  • Kim, Seok-Chan;Lee, Sang-Hoak;Song, So-Hyang;Kim, Young-Kyoon;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1296-1307
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    • 1997
  • Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

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