scholarly journals Effect of miniscrew insertion angle in the maxillary buccal plate on its clinical survival: a randomized clinical trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Amin Golshah ◽  
Kimia Gorji ◽  
Nafiseh Nikkerdar
Keyword(s):  
Clinical Trial ◽  
Survival Rate ◽  
Repeated Measures ◽  
Occlusal Plane ◽  
Controlled Clinical Trial ◽  
Random Allocation ◽  
Canine Retraction ◽  
Insertion Angle ◽  
Link Type ◽  
Significant Difference

Abstract Introduction This study sought to assess the effect of miniscrew insertion angle (vertical and oblique) on its clinical survival under shearing forces in orthodontic patients undergoing canine retraction. Materials and methods In this split-mouth randomized controlled clinical trial, 50 miniscrews were placed bilaterally in 25 patients with 45° and 90° insertion angles relative to a line perpendicular to the occlusal plane distal to the maxillary first premolar extraction site. Allocation of insertion angles to the right/left side was random using the Random Allocation Software. The patients, clinician, and statistician were blinded to the allocation of miniscrews to the side of jaw. The patients were followed-up monthly for 6 months. The primary outcome was the clinical survival of miniscrews, which was evaluated at each follow-up session. The secondary outcomes were the miniscrew stability based on the Periotest value (PTV) and the level of pain experienced by patients at 1, 12, and 24 h, and 7 days after miniscrew placement using a visual analog scale (VAS). Data were analyzed using paired t-test, repeated measures ANOVA, and McNemar’s test. Results The clinical survival rate of miniscrews placed at 90° and 45° angles was 76% and 88%, respectively. This difference was not statistically significant (P = 0.375). No significant difference was noted between the two groups regarding the PTV or the pain score either (P > 0.05). Conclusion Clinically, the insertion angle of miniscrews (90° versus 45° relative to a line perpendicular to the occlusal plane) has no significant effect on the miniscrew survival rate or stability during orthodontic treatment. Trial registration This trial was registered at www.irct.ir (IRCT20190901044659N1). Protocol The protocol was published after trial commencement.

A Multicenter Randomized Double-blind Controlled Clinical Trial of Fiber Post Cementation Strategies

2018 ◽  
Vol 43 (2) ◽  
pp. 128-135 ◽  
Author(s):  
CD Bergoli ◽  
LP Brondani ◽  
VF Wandscher ◽  
GKR Pereira ◽  
MS Cenci ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Survival Rate ◽  
Glass Fiber ◽  
Survival Rates ◽  
The Self ◽  
Controlled Clinical Trial ◽  
Fiber Post ◽  
Resin Cements ◽  
Double Blind ◽  
Significant Difference

SUMMARY Objectives: The aim of this prospective randomized multicenter clinical trial was to evaluate the survival rate of glass fiber–reinforced posts cemented with self-adhesive or regular resin cements. Methods: The sample was comprised of 152 teeth randomized within two centers and in accordance with the adhesive strategies for RelyX U100/U200 (3M ESPE) or Single Bond and RelyX ARC (3M ESPE). The cementation procedures were standardized and performed by previously trained operators. The primary outcome evaluated was post debonding. A trained evaluator, one for each center, assessed all subjects at intervals of 12 months for up to 6 years. Statistical analysis was performed using the Kaplan-Meier method. Results: There was no statistically significant difference in survival rates between the two strategies assessed (p=0.991), with a 92.7% survival rate for the self-adhesive cement and 93.8% for the regular cement. Conclusion: Both the self-adhesive and the regular resin cements are good alternatives for glass fiber post cementation.

scholarly journals The Effect of Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial

2015 ◽  
Vol 4 (1) ◽  
pp. 26-32
Author(s):  
Sara Azima ◽  
Hajar Rajaei Bakhshayesh ◽  
Keramatollah Abbasnia ◽  
Maasumeh Kaviani ◽  
Mehrab Sayadi
Keyword(s):  
Clinical Trial ◽  
Pain Intensity ◽  
Repeated Measures ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Primary Dysmenorrhea ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pharmacological Method

Background: Primary dysmenorrhea is the most common cyclic pelvic pain and is also the most common gynecological problem worldwide and affects quality of life. The present study aimed to investigate the effect of isometric exercises on intensity and duration of pain and level of anxiety in the students with primary dysmenorrhea.Materials and Methods: In this randomized controlled clinical trial, 68 students living in dormitories of Shiraz University with primary dysmenorrhea  were randomly assigned to isometric exercises and control groups. The intervention group performed isometric exercises since the third day of the menstrual cycle for 8 weeks. Pain intensity was measured using Visual Analog Scale (VAS). In addition, the anxiety level was assessed using Spielberger questionnaire. The data were analyzed using independent t-test, repeated measures ANOVA, and Bonferroni Post hoc test at the end of the second and third months of the study. Besides, P<0.05 was considered as statistically significant.Results: Pain intensity and duration of pain was significantly reduced in exercises group (p<0.001). However, no significant difference was found between the two groups concerning the mean anxiety levels.Conclusion: Primary dysmenorrhea is a common complaint among young women. Isometric exercises seem to be an easy, non-pharmacological method for reducing primary dysmenorrheal.

scholarly journals The effects of corticotomy and piezocision in orthodontic canine retraction: a randomized controlled clinical trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Larissa Salgado da Matta Cid Pinto Fernandes ◽  
Daniel Santos Fonseca Figueiredo ◽  
Dauro Douglas Oliveira ◽  
Ricardo Gontijo Houara ◽  
Wellington José Rody ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bone Remodeling ◽  
Distinct Pattern ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Random Allocation ◽  
Randomized Controlled Clinical Trial ◽  
Maxillary Canine ◽  
Canine Retraction ◽  
Randomized Controlled

Abstract Background The aims of this study were to evaluate the efficacy of alveolar corticotomy (AC) and piezocision (PZ) in accelerating maxillary canine retraction, and their effects on multiple bone remodeling expression in gingival crevicular fluid (GCF). A split-mouth, randomized controlled clinical trial was performed at the Department of Orthodontics of Pontifical Catholic University of Minas Gerais, Brazil. Eligibility criteria included orthodontic need for first maxillary premolars extractions, followed by canine retraction. Fifty-one adult patients were recruited and randomly assigned to 3 groups (allocation ratio 1:1:1). Random allocation of surgical or control interventions to each side of the maxillary arch was also conducted: G1 − AC × Control, G2 − PZ × Control, and G3 − AC × PZ. Both the definition of the group and the decision of the experimental or control sides were randomized by the software. Intraoral digital scans were performed before, 7 and 14 days after the beginning of canine retraction, and subsequently, at every 14 days until a maximum period of 6 months. GCF samples were collected before, and 1, 2, 4, 8, and 12 weeks. The primary outcome consisted in the cumulative distal movement of the canines and was measured by digital model superimposition. The secondary outcome consisted in GCF bone remodeling samples that were quantified in a multiplex immunoassay. The measurements examinator was properly blinded. Results Forty-seven patients, 19 males and 28 females, were analyzed (mean age 20.72, SD = 6.66, range 15 to 38). Statistically significant differences in canine distal movement between AC and control in G1 were not observed (p > 0.05). In G2, PZ showed lower cumulative incisal and cervical measurements than control from the 2nd to the 24th week (p < 0.05). In G3, PZ showed a lower cumulative incisal and cervical measurements than AC from the16th to the 24th week (p < 0.05). In all groups, differences on biomarkers expression occurred at specific timepoints (p < 0.05), but a distinct pattern was not observed. Conclusions AC and PZ were not effective to accelerate maxillary canine retraction and did not induce a distinct pattern of biomarker expression. Trial registration NCT03089996. Registered 24 March 2017 - Registered.

scholarly journals Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mojca Jensterle ◽  
Simona Ferjan ◽  
Tadej Battelino ◽  
Jernej Kovač ◽  
Saba Battelino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neural Response ◽  
Taste Perception ◽  
Taste Bud ◽  
Controlled Clinical Trial ◽  
Food Cues ◽  
Link Type ◽  
Visual Food Cues ◽  
Taste Bud Cells

Abstract Background Preclinical studies demonstrated that glucagon-like peptide 1 (GLP-1) is locally synthesized in taste bud cells and that GLP-1 receptor exists on the gustatory nerves in close proximity to GLP-1-containing taste bud cells. This local paracrine GLP-1 signalling seems to be specifically involved in the perception of sweets. However, the role of GLP-1 in taste perception remains largely unaddressed in clinical studies. Whether any weight-reducing effects of GLP-1 receptor agonists are mediated through the modulation of taste perception is currently unknown. Methods and analysis This is an investigator-initiated, randomized single-blind, placebo-controlled clinical trial. We will enrol 30 women with obesity and polycystic ovary syndrome (PCOS). Participants will be randomized in a 1:1 ratio to either semaglutide 1.0 mg or placebo for 16 weeks. The primary endpoints are alteration of transcriptomic profile of tongue tissue as changes in expression level from baseline to follow-up after 16 weeks of treatment, measured by RNA sequencing, and change in taste sensitivity as detected by chemical gustometry. Secondary endpoints include change in neural response to visual food cues and to sweet-tasting substances as assessed by functional MRI, change in body weight, change in fat mass and change in eating behaviour and food intake. Discussion This is the first study to investigate the role of semaglutide on taste perception, along with a neural response to visual food cues in reward processing regions. The study may identify the tongue and the taste perception as a novel target for GLP-1 receptor agonists. Ethics and disseminations The study has been approved by the Slovene National Medical Ethics Committee and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in an international peer-reviewed scientific journal. Trial registration ClinicalTrials.govNCT04263415. Retrospectively registered on 10 February 2020

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals Standard versus Endocuff versus cap-assisted colonoscopy for adenoma detection: A randomised controlled clinical trial

2020 ◽  
pp. 205064062098295
Author(s):  
Martin Floer ◽  
Laura Tschaikowski ◽  
Michael Schepke ◽  
Radoslaw Kempinski ◽  
Katarzyna Neubauer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Screening ◽  
Controlled Clinical Trial ◽  
Polyp Detection ◽  
Withdrawal Time ◽  
Adenoma Detection ◽  
Significant Difference ◽  
Randomised Controlled Clinical Trial ◽  
Randomised Controlled ◽  
Standard Colonoscopy

Background and aims Adenoma detection rate (ADR) in colon cancer screening is most important for cancer prophylaxis. This work is the first three-armed randomised controlled clinical trial aimed at comparing a head-to-head setting standard colonoscopy (SC) with Endocuff-assisted colonoscopy (EC) and cap-assisted colonoscopy (CAC) for improvement of ADR. Methods Patients from Poland and Germany with independent indication for colonoscopy were randomised into three arms of this trial: EC, CAC and SC. Exclusion criteria were age <18 years, active Crohn’s disease or ulcerative colitis, known stenosis and post-colonic resection status. Results A total of 585 patients (195 SC, 189 EC and 186 CAC) were enrolled in this study. Indications were not different between the groups (colorectal cancer screening 51%, diagnostic colonoscopy in 31% and post polypectomy follow-up in 18%; p=0.94). Withdrawal time was a mean of seven minutes in all groups ( p=0.658), and bowel preparation did not differ between the groups. The time to reach the caecum was significantly reduced when using the cap (a mean of six minutes for CAC vs. seven minutes for SC; p=0.0001). There was no significant difference in the primary outcome of the ADR between the groups (EC 32%, CAC 30%, SC 30%; p=0.815). EC proved to be superior (EC vs. SC) in the sigmoid colon and transverse colon for polyp detection. Conclusion The use of EC increased the total number of polyps seen during colonoscopy. In contrast to recent studies, no significant improvement of the ADR was detected.

scholarly journals Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Helda Tutunchi ◽  
Majid Mobasseri ◽  
Samira Pourmoradian ◽  
Hamid Soleimanzadeh ◽  
Behnam Kafil ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Complete Blood Count ◽  
Controlled Clinical Trial ◽  
Medical Sciences ◽  
Boron Compounds ◽  
Double Blind ◽  
Link Type ◽  
Nutrition Research ◽  
Full Protocol

Abstract Objectives In this study, we investigate the effect of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19. Trial design The current study is a single-center, randomized, double-blind, placebo-controlled clinical trial with parallel groups. Participants The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial. The exclusion criteria include regular use of any other supplement, severe and critical COVID-19 pneumonia, pregnancy and breastfeeding. This study is being conducted at Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran. Intervention and comparator Patients are randomly assigned to four groups. The first group (A) will take one capsule containing 5 mg of boron compounds twice a day for two weeks. The second group (B) will take one capsule containing 200 mg oleoylethanolamide twice a day for two weeks. The third group (C) will take one capsule containing 5 mg boron compounds with 200 mg oleoylethanolamide twice a day for two weeks, and the fourth group (D) does not receive any additional treatment other than routine treatments. Boron-containing compounds and oleoylethanolamide capsules will be synthesized at Nutrition Research Center of Tabriz University of Medical Sciences. Main outcomes The primary end point of this study is to investigate the recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles within two weeks of randomization. Randomisation Patients are randomized into four equal groups in a parallel design (allocation ratio 1:1). A randomized block procedure is used to divide subjects into one of four treatment blocks (A, B, C, and D) by a computer-generated allocation schedule. Blinding (masking) The participants and investigators (enrolling, assessing, and analyzing) are blinded to the intervention assignments until the end of the study and data analysis. Numbers to be randomised (sample size) The calculated total sample size is 40 patients, with 10 patients in each group. Trial Status The protocol is Version 1.0, May 17, 2020. Recruitment began May 19, 2020, and is anticipated to be completed by October 19, 2020. Trial registration This clinical trial has been registered by the title of “Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial” in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20090609002017N35”, https://www.irct.ir/trial/48058. The registration date is 17 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Leila Seiiedi-Biarag ◽  
Mojgan Mirghafourvand ◽  
Khalil Esmaeilpour ◽  
Shirin Hasanpour
Keyword(s):  
Mental Health ◽  
Clinical Trial ◽  
Premature Infants ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Postpartum Bonding ◽  
Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

scholarly journals Intravenous paracetamol versus ketorolac for pain attenuation in patients with renal colic; a randomized, single blind and controlled clinical trial

2020 ◽  
Vol 9 (2) ◽  
pp. e10-e10
Author(s):  
Arash Ardestani Zadeh ◽  
Davood Arab ◽  
Mohammadreza Moonesan ◽  
Majid Mirmohammadkhani ◽  
Pouya Morid
Keyword(s):  
Clinical Trial ◽  
Adverse Effects ◽  
Renal Colic ◽  
Vital Signs ◽  
Analgesic Efficacy ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Intravenous Paracetamol ◽  
Significant Difference ◽  
Single Blind

Introduction: Pain control is an essential care for patients with renal colic in emergency wards. Objectives: This study aimed to compare the analgesic efficacy of intravenous (IV) paracetamol (PC) versus ketorolac (KET) for patients with renal colic. Patients and Methods: In a randomized controlled clinical trial, 110 patients with renal colic referred to the emergency department of Kosar hospital, Semnan between October 2015 and June 2016 were selected. Eighty-eight patients were divided into two groups (44 patients in each group) of PC (1 g/IV) and KET (30 mg/IV). One patient in each group was excluded during the study. Vital signs and pain severity (measured by visual analogue scale [VAS]) of all patients were recorded at admission time 0, 20, 40 and 60 minutes after treatment. Then, the results were compared in two groups. Results: The results showed that at the time of 0, 20, 40 and 60 minutes after the administration of the PC and KET drugs, no significant difference was seen in severity of pain based on VAS score between the two groups (P<0.05). Moreover, there were no significant differences in the vital signs of two groups (P<0.05). No adverse effects were reported in each group. Conclusion: In conclusion, the use of IV-PC and KET in patients with renal colic had similar pain relieving effects without any adverse effects.

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