Impact of force magnitude on effectiveness in cervical headgear therapy: a cephalometric analysis

2019 ◽  
Vol 41 (6) ◽  
pp. 646-651 ◽  
Author(s):  
Tuula H Talvitie ◽  
Mika Helminen ◽  
Susanna Karsila ◽  
Reeta Varho ◽  
Luca Signorelli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Cephalometric Analysis ◽  
Force Magnitude ◽  
Lateral Cephalograms ◽  
Significant Difference ◽  
The Impact

Summary Aim The main aim of this study was to study the impact of different force magnitudes on effectiveness in cervical headgear (CHG) therapy. Materials and methods Forty patients were treated with CHG with light (L; 300 g) or heavy (H; 500 g) force in this controlled clinical trial. Patients were asked to wear CHG for 10 hours/day for 10 months. The inner bow of the CHG was expanded (3–4 mm) and the long outer bow bent (10–20 degree) upward in relation to the inner bow. Adherence to instructions and force magnitude in CHG use was monitored by electronic module (Smartgear, Swissorthodontics, Switzerland). Lateral cephalograms were taken before (T1) and after (T2) the treatment and studied with modified Pancherz analysis using a Planmeca Romexis Ceph module (Planmeca, Finland). Results In both groups, skeletal and dental effects were seen. The only statistically significant difference in cephalometric analysis was the inclination of upper incisors at T1 (P = 0.010) and at T2 (P = 0.011). In both groups, a reduction in Sella-Nasion- point A (SNA) angle was found: L group T1 82.7degree (SD ± 3.6degree), T2 82.0degree (SD ± 3.5 degree) and H group T1 82.6 degree (SD ± 4.7 degree), T2 81.5 degree (SD ± 4.5 degree), but no statistically significant difference between the groups. Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002). Conclusion Children with lower force CHG seem to adhere better to instructions for CHG use. After 10 months of use, no statistically significant differences were found in dental or skeletal outcome. However, in the H group, the outcome was achieved with less daily hours of use.

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 The impact of minimally invasive restorative techniques on perception of dental pain among pregnant women: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
May M. Adham ◽  
Mona K. El Kashlan ◽  
Wafaa E. Abdelaziz ◽  
Ahmed S. Rashad
Keyword(s):  
Clinical Trial ◽  
Dental Caries ◽  
Pregnant Women ◽  
Dental Pain ◽  
Controlled Clinical Trial ◽  
Atraumatic Restorative Treatment ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Caries Removal ◽  
The Impact

Abstract Background The public dental care sector is striving to fulfill the preventive and restorative needs of Egyptians, including pregnant women, who may not receive timely care due to misconceptions about dental treatment during pregnancy. Because of this, they are likely to suffer dental pain, with higher risk of infection affecting their offsprings. Aim of the study To compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain among pregnant women. Materials and methods A randomized controlled clinical trial was conducted, in 2019, and included 162 pregnant women visiting family health centers in Alexandria, Egypt, with dental pain due to dental caries not extending to pulp. Patients were randomly assigned to Papacarie-Duo group (n = 82) and ART group (n = 80) after stratification by number of treated surfaces. The outcome variables were reduction in pain assessed using Visual Analogue Scale (VAS), satisfaction with treatment, and time taken for dental caries removal. T test/ Mann Whitney U test were used to compare groups and Freidman test was used to compare change across time. Results Pain reduction was significantly greater in the Papacarie-Duo than the ART group (81.55% and 69.43%, P = 0.001). Patients in the Papacarie-Duo group were significantly more satisfied with treatment than those in the ART, immediately after treatment (mean = 9.60 and 8.00, P =  < 0.01) and after 6 months (mean = 9.63 and 8.16, P =  < 0.01). Significantly less excavation time was recorded in the Papacarie-Duo group than in the ART group (mean = 10.38 and 11.56 min, P =  < 0.01). Conclusion Chemo-mechanical caries removal using Papacarie-Duo is more effective in reducing dental pain, in pregnant women, and is associated with more satisfaction and less excavation time than ART. Trial registration: ID NCT04573608 (https://clinicaltrials.gov/); 5/10/2020, retrospective registration.

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.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. e1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]  

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

2019 ◽  
Vol 53 ◽  
Author(s):  
Luciana Regina Ferreira da Mata ◽  
Cissa Azevedo ◽  
Mariana Ferreira Vaz Gontijo Bernardes ◽  
Tânia Couto Machado Chianca ◽  
Maria da Graça Pereira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Home Care ◽  
Self Efficacy ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Teaching Program ◽  
Significant Difference ◽  
The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

scholarly journals Effectiveness of cyproheptadine in the prevention of childhood migraine

2009 ◽  
Vol 49 (5) ◽  
pp. 286
Author(s):  
Zulkarnain Zulkarnain ◽  
Johannes Saing ◽  
Yazid Dimyati ◽  
Bistok Saing
Keyword(s):  
Clinical Trial ◽  
Prophylactic Treatment ◽  
Functional Disability ◽  
International Headache Society ◽  
Controlled Clinical Trial ◽  
Headache Frequency ◽  
Disability Assessment ◽  
Childhood Migraine ◽  
Pediatric Migraine ◽  
Significant Difference

Background Migraine is one of the causes of recurrent headachein childhood. Cyproheptadine is well known as an antihistamine,but there are few studies revealing the drug's effect in pediatricmigraine.Objective To determine the effectiveness of cyproheptadine in the prophylactic treatment of childhood migraine.Methods A randomized placebo-controlled clinical trial studywas performed at Medan. One hundred children with migraineaccording to the International Headache Society criteria wereincluded in the study. Subjects were divided into two groups, andeach group was given either 4 mg cyproheptadine or placebo for 12 weeks. Headache frequency was measured in headache days per month, duration was measured in hours and functional disability was measured by Pediatric Migraine Disability Assessment (PedMID AS). The efficacy was measured before intervention; also 1, 2, and 3 months after intervention.Results A total of 100 patients, with age ranging from 11 to 18 years old (with mean, 15.5 years), were treated with cyproheptadine or placebo for headache. Compared to baseline, there was a significant difference on PedMIDAS grading of migraines in both groups (P<0.05). Headache frequency and duration per month were significantly different after treatment with cyproheptadine (P=0.009, 95% CI 0.001 to 0.030 and P= 0.029, 95% CI 0.690 to 27.510, RR=4.36), compared to placebo group (P> 0.05), but there were side effects of cyproheptadine up to 73%.Conclusion Cyproheptadine appears to be effective as analternative prophylactic treatment of childhood migraine.However, pediatricians should consider the significant side effectsof this drug.

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