scholarly journals Comparison of anterior retraction and anchorage control between en masse retraction and two-step retraction: A randomized prospective clinical trial

2018 ◽  
Vol 89 (2) ◽  
pp. 190-199 ◽  
Author(s):  
Patricia Pigato Schneider ◽  
Luiz Gonzaga Gandini Júnior ◽  
André da Costa Monini ◽  
Ary dos Santos Pinto ◽  
Ki Beom Kim
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Secondary Outcome ◽  
Space Closure ◽  
The Difference ◽  
Maxilla And Mandible ◽  
Anchorage Loss ◽  
Bimaxillary Protrusion ◽  
Best Fit ◽  
En Masse Retraction

ABSTRACT Objectives: The purpose of this two-arm parallel trial was to compare en masse (ER) and two-step retraction (TSR) during space closure. Materials and Methods: Forty-eight adult patients with bimaxillary protrusion who were planned for treatment with extraction of four first premolars were enrolled. All patients were randomly allocated in a 1:1 ratio to either the ER (n = 24) group or the TSR (n = 24) group. The main outcome was the amount of posterior anchorage loss in the molars and the retraction of the incisors between ER and TSR; the difference in incisor and molar inclination was a secondary outcome. Lateral cephalometric radiographs and oblique cephalometric radiographs at 45° were taken before retraction (T1) and after space closure (T2). Cephalograms were digitized and superimposed on the anatomic best fit of the maxilla and mandible by one operator who was blinded to the treatment group. Results: Neither incisor nor molar crown movements showed any significant differences between the ER and TSR. There were no significant differences in the tipping of incisors and molars between the two groups. Conclusions: No significant differences existed in the amount of retraction of incisors and anchorage loss of molars between ER and TSR. Changes in incisor and molar tipping were similar, with the crowns showing more movement than the apex.

Effects of acupuncture on anthropometric and serum metabolic parameters in premenopausal overweight and obese women: a randomized, patient- and assessor-blind, sham-controlled clinical trial

2020 ◽  
pp. 096452842091225
Author(s):  
Koh-Woon Kim ◽  
Woo-Chul Shin ◽  
Min Sun Choi ◽  
Jae-Heung Cho ◽  
Hi-Joon Park ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Serum Lipid ◽  
Sham Acupuncture ◽  
Metabolic Parameters ◽  
Secondary Outcome ◽  
Control Group ◽  
Lipid Levels ◽  
Serum Lipid Levels

Objective: The aim of this study was to examine the effect of acupuncture on obesity-related parameters with regard to metabolomics. Methods: This two-arm parallel, patient- and assessor-blind, sham-controlled randomized clinical trial included 120 obese participants. Participants were randomized into two groups. The treatment group received a combined intervention of manual acupuncture (MA) plus electroacupuncture (EA), while the control group received a combination of sham acupuncture interventions consisting of sham MA plus sham EA for 6 weeks. The serum lipid levels were measured as the primary outcome measure and anthropometric parameters and serum metabolic profiles including amino acids and carnitines were measured as secondary outcome measures. Results: The serum lipid levels and anthropometric measurements did not significantly differ between groups, while body weight, body mass index (BMI), and waist circumference were improved within each group and the level of high-density lipoprotein cholesterol increased over time in the treatment group. There were no significant differences in amino acid levels between groups, while certain carnitine (C2, C4, C6, and l-carnitine) levels were significantly increased ( p < 0.05) in the treatment group compared to the control group. Conclusion: In summary, 6 weeks of acupuncture treatment did not affect anthropometric and serum metabolic parameters, with the exception of certain carnitines, when compared to sham acupuncture. The observation of increased carnitine levels in the acupuncture group could result in potential long-term benefits to obese individuals. Additional studies are needed to investigate the long-term effects of acupuncture on lipid metabolism and the underlying mechanism of action. Trial registration number: This study is registered at ClinicalTrials.gov (NCT02066090).

scholarly journals Comparison of dual-dimensional and rectangular wires in terms of space closure and anchorage loss during retraction with miniimplants: A prospective clinical study

2020 ◽  
Vol 14 (1) ◽  
pp. 54-60
Author(s):  
Sangeetha Morekonda Gnaneswar ◽  
Premkumar Sridhar
Keyword(s):  
Statistical Significance ◽  
Torque Control ◽  
Control Group ◽  
Prospective Clinical Study ◽  
Mini Implants ◽  
Space Closure ◽  
Significant Difference ◽  
The Difference ◽  
Anchorage Loss ◽  
Sliding Mechanics

Background . In sliding mechanics, archwires should slide easily during the retraction of anteriors. Round wires slide well, but the torque control is a significant problem. Rectangular wires produce effective torque expression but pose a challenge to free sliding due to factors like friction and force used to overcome friction, etc. To utilize the properties of both wires, the wire should be bi-dimensional. Dual-dimensional wire is one such wire with different dimensions in the anterior and posterior sections. This study aimed to compare the amount of space closure and anchorage loss of molars between the rectangular and dual-dimensional wire groups during retraction with mini-implants. Methods. Forty patients were randomly allocated to two groups (n=20). Patients with rectangular wires formed the control group, and those with dual-dimensional wires formed the experimental group. Mini-implants and NiTi coil springs were used for retraction. Model and cephalometric analyses were carried out to calculate the amount of space closure and anchor loss, before and four months after the study. Statistical significance was set at P<0.05. Results. The average amount of space closure was higher with DDW (3.98 mm) than rectangular wire (3.22 mm). The difference was statistically significant. No significant difference was found with anchorage loss. Conclusion. DDW can be used as an alternative to rectangular wires during retraction with mini-implants; however, it cannot replace the rectangular wires completely. Anchorage control was effective with both wires.

scholarly journals Evaluation of the efficacy of recombinant tissue plasminogen activators in improving clinical status of acute ischemic stroke: A randomized clinical trial in Iran

2018 ◽  
Vol 5 (9) ◽  
pp. 2697-2702
Author(s):  
Mojtaba Khazaei ◽  
Zaher Khazaei ◽  
Elham Goodarzi ◽  
Ali Ghadimi
Keyword(s):  
Clinical Trial ◽  
Ischemic Stroke ◽  
Treatment Group ◽  
Acute Ischemic Stroke ◽  
Clinical Status ◽  
Plasminogen Activators ◽  
Control Group ◽  
Tissue Plasminogen ◽  
The Mean ◽  
The Difference

Background: Acute ischemic stroke is caused by blockage of a cerebral artery and is also known as cerebrovascular accident (CVA). Recombinant tissue plasminogen activator (rt-PA) therapy is effective in reducing early and long-term neurologic disabilities if it is started quickly. Therefore, the aim of this study was to determine the efficacy of treatment with recombinant tissue plasminogen activators in improving the clinical status of acute ischemic stroke. Methods: The current study was performed as a clinical trial of two groups- treatment and control (n=20 per group). The treatment group consisted of patients who received rt-PA, while the control group consisted of patients who did not receive rt-PA. For each group, evaluation of neurological disabilities following ischemic stroke was based off the National Institutes of Health Stroke Scale (NIHSS), for early assessment of disability on the third day of treatment), and off the modified Rankin Scale (MRS) at 90 days after stroke. The drug effect criterion was used to reduce the neurological disability or the difference in NIHSS on day 3 after treatment. Also, the duration of onset of symptoms until the arrival of the patients to the emergency room (ER), as well as the risk factors, complications and number of deaths in both groups, were recorded. Data obtained were analyzed by SPSS software. Results: The results of the study showed that the mean of ER arrival time, NIHSS before treatment, and NIHSS on day 3 of treatment in the control group was higher than that of the treatment group; the difference was statistically significant (P<0.05). The results also indicated that the probability of improvement of neurological disabilities in the experimental group was greater than that of the control group (relative risk (RR) =1.25). Additionally, the odds ratio (OR) for receiving rt-PA in the NIHSS positive treatment group compared to the control group was equal to 1/5 (OR=1.5). The results showed that 30% of the patients in the treatment group were treated with a complication. The mean of MRS was higher in the control group at 90 days after the stroke, compared with the treatment group. Conclusion: Treatment with rt-PA reduces the neurological disability in patients with ischemic stroke, since the mean of MRS is lower in the treatment group, compared with the control group, after 90 days of treatment.

scholarly journals Efficacy of a Chinese Herbal Medicine, Qinzhuliangxue Granules, for The Treatment of Eczema: A Randomized, Double-Blind, Multi-Center Clinical Trial

2021 ◽  
Author(s):  
Ruiping Wang ◽  
Qi Zheng ◽  
Yu Chen ◽  
Su Li ◽  
Wencheng Jiang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Western Medicine ◽  
Repeated Measures ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Double Blind ◽  
Chinese Herbal

Abstract Background: Eczema is the most common allergic skin disorder in the world. The treatment of eczema with western medicine generally involves antihistamines, antibiotics, glucocorticoids, and immunomodulatory preparations, which are limited by common relapse events following drug withdrawal. Many traditional Chinese medicines have demonstrated significant effects on eczema; however, high-quality clinical studies are lacking.Objectives: We performed a multi-center, randomized, double-blind, clinical trial to evaluate the efficacy and safety of a Chinese herbal medicine, Qinzhuliangxue (QZLX) granules, and its effect on recurrence of eczema.Methods: A total of 342 patients with eczema who met the inclusion criteria were recruited and randomly divided into a traditional Chinese medicine (TCM) treatment group, a Western medicine (WM) treatment group, and a TCM plus WM treatment group, according to random numbers generated using the central stratified zone group random method. The Eczema Area and Severity Index (EASI) score and the level of pruritus were set as the primary outcome measures, and the Dermatology Quality of Life Index (DLQI) score served as the secondary outcome measure. In this study, a two-sided p-value less than 0.05 was considered statistically significant. Results: The median EASI score and the pruritus level at baseline were not statistically significant. However, as the treatment period progressed, the EASI score (including the total score and scores for the head, upper limb, trunk, and lower limb) and pruritus level decreased significantly in all three treatment groups. Repeated measures Analysis of Variance (ANOVA) demonstrated that the DLQI scores in the TCM, WM, and TCM+WM groups decreased significantly over time. Limitations: Basic experiments need to be increased.Conclusions: The Chinese herbal medicine QZLX granules significantly improved the EASI score and decreased the pruritus level in eczema patients, with good safety and no obvious adverse reactions.Trial RegistrationThe protocol for this study was registered with the Clinical Trials database (NCT02517957). Registered 1 May 2015, Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research - Full Text View - ClinicalTrials.gov

scholarly journals I-FiBH trial: intravenous fluids in benign headaches—a randomised, single-blinded clinical trial

2020 ◽  
pp. emermed-2019-209389
Author(s):  
Tony Zitek ◽  
Tiffany Sigal ◽  
Gina Sun ◽  
Chris Martin Manuel ◽  
Khanhha Tran
Keyword(s):  
Clinical Trial ◽  
Normal Saline ◽  
Statistical Power ◽  
Pain Reduction ◽  
Intravenous Fluid ◽  
Secondary Outcome ◽  
Control Group ◽  
Fluid Bolus ◽  
Significant Difference ◽  
The Difference

BackgroundMany emergency physicians use an intravenous fluid bolus as part of a ‘cocktail’ of therapies for patients with headache, but it is unclear if this is beneficial. The objective of this study was to determine if an intravenous fluid bolus helps reduce pain or improve other outcomes in patients who present to the ED with a benign headache.MethodsThis was a randomised, single-blinded, clinical trial performed on patients aged 10–65 years old with benign headaches who presented to a single ED in Las Vegas, Nevada, from May 2017 to February 2019. All patients received prochlorperazine and diphenhydramine, and they were randomised to also receive either 20 mL/kg up to 1000 mL of normal saline (the fluid bolus group) or 5 mL of normal saline (the control group). The primary outcome was the difference between groups in mean pain reduction 60 min after the initiation of treatment. Secondarily, we compared groups with regards to pain reduction at 30 min, nausea scores, the use of rescue medications and disposition.ResultsWe screened 67 patients for enrolment, and 58 consented. Of those, 35 were randomised to the fluid bolus group and 23 to the control group. The mean pain score dropped by 48.3 mm over 60 min in the fluid bolus group, compared with 48.7 mm in the control group. The between groups difference of 0.4 mm (95% CI −16.5 to 17.3) was not statistically significant (p=0.96). Additionally, no statistically significant difference was found between groups for any secondary outcome.ConclusionThough our study lacked statistical power to detect small but clinically significant differences, ED patients who received an intravenous fluid bolus for their headache had similar improvements in pain and other outcomes compared with those who did not.Trial registration numberNCT03185130.

scholarly journals Metformin as a New Perspective in the Medical Management of Breast Fibroadenoma; A Randomized Clinical Trial Study

2021 ◽  
Author(s):  
Sadaf Alipour ◽  
Mahboubeh Abedi ◽  
Azin Saberi ◽  
Arezoo Maleki-Hajiagha ◽  
Firoozeh Faiz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treatment Group ◽  
Randomized Clinical Trial ◽  
Favorable Effect ◽  
Female Sex Hormones ◽  
Before And After ◽  
The Difference ◽  
New Perspective ◽  
Higher Doses

Abstract Background: Fibroadenoma (FA) is the most common benign solid breast mass in women with no definite method of management. Because fibroadenoma is dependent on female sex hormones, we investigated the effects of metformin, a safe hypoglycemic agent with anti-estrogenic and anti-proliferative properties, in the management of fibroadenoma. Methods: In this randomized clinical trial study, eligible women with fibroadenomas were assigned randomly to the metformin (1000 mg daily), or the placebo group. Breast physical and ultrasound exam was performed before and after the intervention, and the changes in the size of fibroadenomas were compared in the two groups. Results: Overall, 83 patients in the treatment, and 92 in the placebo group completed the study. The mean age of participants was 39.65±10.30 years. The amount of reduction in the size of FA was two-fold in the treatment than placebo group. We categorized size changes of FAs into < 20% enlargement (success) and ≥ 20% enlargement (failure). The odds ratio (OR) for success was 1.48 (95% CI=1.10-1.99) in the treatment group in comparison with the placebo group; and the odds for success was higher in women with multiples fibroadenomas (OR=4.67, 95% CI: 1.34-16.28). Also, the rate of disappearance of fibroadenomas in the treatment group was two-fold higher than the placebo group, although the difference was not statistically significant. Conclusion: This is the first study that evaluates the effect of MF on the management of fibroadenoma, and the results suggest a favorable effect. Larger studies including only large lesions and using higher doses of metformin are suggested to confirm these results.Trial Registration: This trial (IRCT20100706004329N7) was retrospectively registered on 2018-10-07.

Convergence Insufficiency Treatment Trial – Attention and Reading Trial (CITT-ART): Design and Methods

2015 ◽  
pp. 214-228 ◽  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Health Care Providers ◽  
Developmental Disorders ◽  
Attention Problems ◽  
Secondary Outcome ◽  
Care Providers ◽  
Treatment Trial ◽  
Additional Hypothesis ◽  
Convergence Insufficiency

Objective: To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods: CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion: The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.

Clinical Study of Qingpeng Ointment Treatment of Shoulder-Hand Syndrome After Cerebral Hemorrhage During the Rehabilitation Period

2020 ◽  
Vol 23 ◽  
Author(s):  
Ruihuan Pan ◽  
Shanshan Ling ◽  
Haodong Yang ◽  
Yan Huang ◽  
Lechang Zhan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Cerebral Hemorrhage ◽  
Clinical Medicine ◽  
External Rotation ◽  
Statistical Significance ◽  
Hand Function ◽  
Tibetan Medicine ◽  
Controlled Study ◽  
Control Group ◽  
The Difference

Background: Shoulder-hand syndrome (SHS) refers to a syndrome causing sudden edema, shoulder pain and limited hand function. Qingpeng ointment, a kind of Tibetan medicine, can reduce swelling, relieve pain, tonify stagnation and clear the meridians, which is consistent with the pathological mechanism of SHS after stroke. Therefore, if clinical trials can be used to explore the effectiveness of Qingpeng ointment for treatment of poststroke SHS and promote its application in clinical medicine, this is of specific significance for the treatment of poststroke SHS. Objective: To investigate the clinical efficacy and safety of Qingpeng ointment in the treatment of poststroke SHS. To provide an objective basis for a better therapeutic treatment for poststroke SHS． Method: A prospective, randomized, controlled study was conducted. This study recruited 120 patients with poststroke SHS who met the inclusion criteria. They were randomized into the treatment group and the control group, with 60 patients allocated to each group. The treatment group received routine medical treatment and rehabilitative care after using the Qingpeng ointment, while the patients in the control group received only routine treatment without the ointment. All patients received clinical assessment with the Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI) before and after the whole treatment. Results: After 4 weeks of treatment, the VAS scores of both groups were decreased significantly (P＜0.05), and the difference between the two groups was statistically significant (P < 0.05). There is no statistical significance for the difference between the treatment group and control group in terms of the FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles after treatment. The increases in the values of VAS, FMA-M and MBI in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). The increases in the values of the forward bend, outreach and external rotation angles in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). Conclusion: The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage. Qingpeng ointment is effective and safe in treating poststroke SHS.

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