• 제목/요약/키워드: randomized clinical trial

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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.
    • 대한치과교정학회지
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    • 제51권5호
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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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    • 제47권2호
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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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    • 제43권3호
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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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    • 제22권5호
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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
    • 대한치과교정학회지
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    • 제49권5호
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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.

Horizontal instability after acromioclavicular joint reduction using the two-hole technique is preferred over the loop technique: a single-blind randomized clinical trial

  • Mardani-Kivi, Mohsen;Asadi, Kamran;Leili, Ehsan Kazemnejad;Hashemi-Motlagh, Keyvan;Izadi, Amin;Pishgahpour, Mona;Darabipour, Zohre
    • Clinics in Shoulder and Elbow
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    • 제25권3호
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    • pp.224-229
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    • 2022
  • Background: Most acromioclavicular joint (ACJ) injuries are caused by direct trauma to the shoulders, and various methods and techniques are used to treat them; however, none of the options can be considered the gold standard. This study examines the horizontal stability of the ACJ after a complete dislocation was repaired using one of two Ethibond suture techniques, the loop technique and the two holes in the clavicle technique. Methods: In this single-blind, randomized clinical trial, 104 patients diagnosed with complete ACJ dislocation type V were treated using Ethibond sutures with either the loop technique or the two holes in the clavicle technique. Horizontal changes in the ACJ were radiographically assessed in the lateral axial view, and shoulder function was evaluated by the Constant (CS) and Taft (TS) scores at intervals of 3, 6, and 12 months after surgery. Results: The horizontal stability of the ACJ was better with the two-hole technique than the loop technique at all measurement times. CS and TS changes showed a significant upward trend over time with both techniques. The mean CS and TS at the final visit were 95.2 and 11.6 with the loop technique and 94.0 and 11.9 with the two-hole technique, respectively. The incidence of superficial infections caused by the subcutaneous pins was the same in the two groups. Conclusions: Due to the improved ACJ stability with the two-hole technique, it appears to be a more suitable option than the loop technique for AC joint reduction.

Effectiveness of low-level laser therapy in facilitating maxillary expansion using bone-borne hyrax expander: A randomized clinical trial

  • Abdelwassie, Sara Hassan;Kaddah, Mohammed Amgad;El-Dakroury, Amr Emad;El-Boghdady, Dalia;Abd El-Ghafour, Mohamed;Seifeldin, Nouran Fouad
    • 대한치과교정학회지
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    • 제52권6호
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    • pp.399-411
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    • 2022
  • Objective: The objective of this randomized clinical trial was to study the skeletal and dental effects of low-level laser therapy (LLLT) along with a miniscrew-assisted expander (Hyrax) after six months of retention. Methods: After sequence generation, concealed allocation, and implementation, 24 female patients were randomly divided (1:1) into two-groups: bone-borne rapid palatal expansion (BBE) without LLLT (n = 12) and BBE with LLLT (n = 12). Eligibility criteria included female patients aged 10-13 years old with bilateral posterior crossbites. Intraoral and extraoral photographs, cone-beam computed tomography images, and digital study models were obtained before expansion and six months after retention. The 7 mm Hyrax appliance was anchored to four palatal mini-screws, which were activated twice daily for 15 days, then locked and kept in place as a retainer. LLLT was performed in the laser group during expansion and retention, according to the guidelines provided. Results: The records of 24 patients were analyzed. According to the post-retention measurements, both groups showed a significant increase in nasal and maxillary widths and total facial height. In the laser group, the Sella-Nasion-Point A and Point A-Nasion-Point B angles and the interpremolar apical distance were significantly increased. Conclusions: Within the limitations of this study, the results suggest that the parameters and protocol of LLLT do not clinically affect the efficiency of BBE in prepubertal and pubertal patients.

소아 키 성장에 미치는 한삼덩굴추출분말의 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜 (Randomized, Double-blind, and Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Humulus japonicus Extract Powder on Child Height Growth: Study Protocol)

  • 장수비;최봄;천진홍;김기봉
    • 대한한방소아과학회지
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    • 제37권3호
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    • pp.121-132
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    • 2023
  • Objectives We aimed to confirm whether Humulus japonicus Extract Powder can enhance child height growth significantly and safely compared with a placebo. Methods A total of 150 children between the 3rd and 25th percentiles in height and between the ages of 6 and 9 years will be recruited to participate in this randomized, double-blind, placebo-controlled clinical trial. The participants will be randomly assigned to the treatment or placebo group. Participants in the treatment group will take one pack per day (700 mg of Humulus japonicus Extract Powder) for 24 weeks. Participants in the placebo group will take one package of placebo per day (0 mg of Humulus japonicus Extract Powder) for 24 weeks. The primary outcome will be a change in height after 12 weeks, and the secondary outcomes will be the height after 24 weeks, growth rate, height standard deviation, growth hormone, insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), bone alkaline phosphatase (BALP), and osteocalcin after 12 and 24 weeks. Results This protocol was approved by the Institutional Review Board (IRB) of the Korean Medicine Hospital of Busan University (IRB No. PNUKHIRB-2023-03-002). Research participants will be recruited from June 2023 to December 2023. Conclusions The results of this study provide clinical information regarding the effectiveness and safety of the Humulus japonicus Extract Powder in increasing child height.

Efficacy of buccal piroxicam infiltration and inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial

  • Saurav Paul;Sridevi Nandamuri;Aakrati Raina;Mukta Bansal
    • Restorative Dentistry and Endodontics
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    • 제46권1호
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    • pp.9.1-9.9
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    • 2021
  • Objectives: This randomized clinical trial aimed to assess the effectiveness of buccal infiltration with piroxicam on the anesthetic efficacy of inferior alveolar nerve block (IANB) with buccal infiltration in irreversible pulpitis, with pain assessed using the Heft-Parker visual analogue scale (HP-VAS). Materials and Methods: This study included 56 patients with irreversible pulpitis in mandibular molars, randomly distributed between 2 groups (n = 28). After evaluating the initial pain score with the HP-VAS, each patient received IANB followed by buccal infiltration of 2% lignocaine with adrenaline (1:80,000). Five minutes later, the patients in groups 1 and 2 were given buccal infiltration with 40 mg/2 mL of piroxicam or normal saline, respectively. An access opening procedure (AOP) was performed 15 minutes post-IANB once the individual showed signs of lip numbness as well as 2 negative responses to electric pulp testing. The HP-VAS was used to grade the patient's pain during caries removal (CR), AOP, and working length measurement (WLM). Successful anesthesia was identified either by the absence of pain or slight pain through CR, AOP, and WLM, with no requirement of a further anesthetic dose. A statistical analysis was done using the Shapiro-Wilk and Mann-Whitney U tests. Results: The piroxicam group presented a significantly lower (p < 0.05) mean pain score than the saline group during AOP. Conclusions: Buccal infiltration with piroxicam enhanced the efficacy of anesthesia with IANB and buccal infiltration with lignocaine in patients with irreversible pulpitis.

Effectiveness of laser-engineered copper-nickel titanium versus superelastic nickel-titanium aligning archwires: A randomized clinical trial

  • Omar Khairullah Ahmed;Ammar Salim Kadhum
    • 대한치과교정학회지
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    • 제54권1호
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    • pp.16-25
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    • 2024
  • Objective: To compare the effectiveness of laser-engineered copper-nickel titanium (SmartArch) and superelastic nickel-titanium (SENT) archwires in aligning teeth and inducing root resorption and pain experienced by patients. Methods: Two-arm parallel groups with a 1:1 allocation ratio were used. The participants were patients aged 11.5 years and older with 5-9 mm of mandibular anterior crowding who were indicated for non-extraction treatment. The primary outcome was alignment effectiveness, assessed using Little's irregularity index (LII) over 16 weeks with a single wire (0.016-inch) in the SmartArch group and 2 wires (0.014- and 0.018-inch) in the SENT group (8 weeks each). Secondary outcomes included root resorption evaluated by pre- and post-intervention periapical radiographs and pain levels recorded by the participants during the first week. Results: A total of 40 participants were randomly allocated into 2 groups; 33 completed the study and were analyzed (16 in the SmartArch group and 17 in the SENT group, aged 16.97 ± 4.05 years). The total LII decrease for the SmartArch and SENT groups was 5.63 mm and 5.29 mm, respectively, which was neither statistically nor clinically significant. Root resorption was not significantly different between the groups. The difference in pain levels was not statistically significant for the first 5 days following wire placement; however, there was a significant difference favoring the SENT group in the final 2 days. Conclusions: SmartArch and SENT archwires were similarly effective during the alignment phase of orthodontic treatment. Root resorption should be observed throughout the treatment with either wire. SmartArch wires demonstrated higher pain perception than SENT wires.