Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial

2020 ◽  
Author(s):  
Jenny Kallunki ◽  
Lars Bondemark ◽  
Liselotte Paulsson
Keyword(s):  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Untreated Control ◽  
Controlled Trial ◽  
Class Ii ◽  
Control Group ◽  
Class Ii Malocclusion ◽  
Single Centre ◽  
Intention To Treat ◽  
Randomized Controlled

Summary Objectives To compare early headgear activator treatment of Class II malocclusion with excessive overjet with untreated control subjects in terms of the primary outcomes overjet and overbite as well as the effect regarding oral-health-related quality of life (OHRQoL), lip closure, incidence of trauma, and skeletal changes. Trial design Two-arm parallel group single-centre randomized controlled trial. Material and methods A total of 60 children (mean age 9.5 years) presenting a Class II malocclusion with excessive overjet were recruited. The trial was designed as intention-to-treat and the participants randomized by an independent person not involved in the trial to either early treatment with headgear activator or to an untreated control group (UG). Dental and skeletal variables as well as registrations of OHRQoL, lip closure, and incidence of trauma were recorded. For the treatment group, data were registered at baseline before treatment and when treatment was finished, corresponding to approximately 2 years. For the UG, registrations were made at baseline and at 11 years of age. Observers were blinded to treatment allocation when assessing outcomes. Results Early treatment with headgear activator significantly decreased overjet and improved molar relationship when compared with untreated controls. The effects were primarily due to dentoalveolar changes. Early treatment had no evident effect regarding OHRQoL, lip closure, or incidence of trauma. Lack of cooperation resulted in unsuccessful treatments for 27% of the patients. Limitations The trial was a single-centre trial and can thus be less generalizable. Conclusions The main treatment effect of early headgear activator treatment of Class II malocclusion with excessive overjet is reduction of overjet. Trial registration NCT04508322.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

scholarly journals Comparison of effects of cervical headgear treatment on skeletal facial changes when the treatment time is altered: a randomized controlled trial

2019 ◽  
Vol 41 (6) ◽  
pp. 631-640
Author(s):  
Johanna Julku ◽  
Kirsi Pirilä-Parkkinen ◽  
Mimmi Tolvanen ◽  
Pertti Pirttiniemi
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Class Ii ◽  
Class Ii Malocclusion ◽  
Gonial Angle ◽  
Randomized Controlled ◽  
Face Height ◽  
Upper Face ◽  
Facial Changes

Summary Background There is a lack of evidence based on longitudinal information in the field of Class II malocclusion management with cervical headgear (CH), especially in a randomized setting. Objectives The main objective of this study was to evaluate skeletal facial changes, particularly in vertical dimensions, after Kloehn-type CH treatment in children when the timing of treatment is altered. Trial design Prospective, parallel-group, randomized controlled trial. Methods Screened children with Class II malocclusion were randomized in 1:1 ratio to two groups of equal size by sealed-envelope randomization: the early group (EG), where active CH treatment was started at the age of 7.8 years, and the late group (LG), where CH treatment was started at the age of 9.5 years. The active treatment was continued until normal Class I occlusion on first molars was achieved. Cephalograms were taken at three different time points. Changes in cephalometric measurements were compared between groups and genders. Blinding was applicable for outcome evaluation. Results Of 67 randomized children, 56 completed the study. Upper face height increased during the CH treatment phase, as the parameter N–ANS increased significantly during the active treatments of EG (P < 0.05) and LG (P < 0.05). Also, the parameter NSL–PL increased significantly during the treatment of EG (P < 0.01) and during the treatment of LG (P < 0.01). The Gonial angle decreased significantly in the early CH treatment group compared to the later treatment group (T0–T2: P < 0.01). CH improved the antero-posterior jaw relationship. No harms were encountered. Conclusions Although the upper face height increased, the mandible showed anterior rotation after CH treatment. The Gonial angle was significantly decreased in the EG compared to the LG. There were gender-specific differences in both sagittal and vertical dimensions when examining interrelations in dimensional changes. The differences found between the early and later treatment groups were not clinically important when the cephalometric results are considered. Clinical registration ClinicalTrials.gov (NCT02010346).

Stability of maxillary anterior teeth after 2 years of retention in adolescents: a randomized controlled trial comparing two bonded and a vacuum-formed retainer

2020 ◽  
Author(s):  
Sasan Naraghi ◽  
Niels Ganzer ◽  
Lars Bondemark ◽  
Mikael Sonesson
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Contact Point ◽  
Three Dimensional ◽  
Final Analysis ◽  
Single Centre ◽  
Retention Capacity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Anterior Teeth

Summary Background Retention of the maxillary anterior teeth is commonly recommended to maintain the teeth in their corrected positions. Both fixed and removable retention methods are used, but the certainty of evidence is low. Objective To evaluate post-treatment changes in irregularity of the maxillary six anterior teeth and single tooth contact point discrepancy (CPD) of three different retention methods. Trial design Three-arm parallel group single-centre randomized controlled trial. Materials and methods Ninety patients, 54 girls and 36 boys, were recruited to the study. The inclusion criteria were adolescent patients treated with fixed appliances at least in the maxilla. After gaining informed consent from the patient and their custodians, the patients were randomized to one of three groups: bonded retainer 13–23, bonded retainer 12–22, and removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization, prepared by an independent person, used blocks of 30. The primary outcomes were changes in single CPD and Little’s irregularity index (LII) measured on digitalized three-dimensional study casts before and after 2-year retention. The study casts were anonymized before assessment and the changes were blinded for the assessor. Data were evaluated on an intention-to-treat basis. Thus, all randomized patients were incorporated into the final analysis. Results The LII and CPDs increased slightly in all three groups without any statistically significant differences between the groups. The VFR group showed a small intercanine width increase and some more changes of canine rotations than in the other groups. Harms No harm was observed in any subjects and none of the patients needed retreatment. Limitations The trial was a single-centre study and short-term changes were evaluated. Conclusions All three retention methods showed equally effective retention capacity and all the changes found in the three groups were small and considered clinically insignificant. Thus, the null hypothesis was confirmed. All three methods can be recommended. Trial registration NCT04616755

scholarly journals Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
R. Casañas ◽  
R. Catalán ◽  
R. Penadés ◽  
J. Real ◽  
S. Valero ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Antidepressant Medication ◽  
Psychoeducational Intervention ◽  
Control Group ◽  
Intention To Treat ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Treatment Naïve

Background. There is evidence supporting the effectiveness of psychoeducation (PE) in patients with symptoms of depression in primary care (PC), but very few studies have assessed this intervention in antidepressant-naïve patients. The aim of this study is to assess the effectiveness of a PE program in these patients, since the use of antidepressant (AD) medication may interfere with the effects of the intervention.Methods. 106 participants were included, 50 from the PE program (12 weekly 1.5-hour sessions) and 56 from the control group (CG) that received the usual care. Patients were assessed at baseline and at 3, 6, and 9 months. The main outcome measures were the Beck Depression Inventory (BDI) and remission based on the BDI. The analysis was carried out on an intention-to-treat basis.Results. The PE program group showed remission of symptoms of 40% (P=0.001) posttreatment and 42% (P=0.012) at 6 months. The analysis only showed significant differences in the BDI score posttreatment (P=0.008; effect size Cohen’sd′=0.55).Conclusions. The PE intervention is an effective treatment in the depressive population not treated with AD medication. Before taking an AD, psychoeducational intervention should be considered.

scholarly journals Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial

2020 ◽  
Vol 75 (11) ◽  
pp. 3373-3378 ◽  
Author(s):  
Hamideh Abbaspour Kasgari ◽  
Siavash Moradi ◽  
Amir Mohammad Shabani ◽  
Farhang Babamahmoodi ◽  
Ali Reza Davoudi Badabi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Stay ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Single Centre ◽  
Mazandaran Province ◽  
Randomized Controlled

Abstract Background New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19. Methods This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1. Results Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray’s P = 0.033). Conclusions This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.

scholarly journals 150. the RAPID trial: randomized Controlled Trial assessing point-of-care influenza and Other Respiratory Virus diagnostics in the Pediatric ED Setting

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S205-S205
Author(s):  
Suchitra Rao ◽  
Molly Lamb ◽  
Angela Moss ◽  
Rakesh Mistry ◽  
Samuel Dominguez
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Antibiotic Use ◽  
Control Group ◽  
Research Support ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
To Receive

Abstract Background Respiratory illnesses represent one of the commonest reasons for pediatric visits to the ED, and over 50% of these children are prescribed antibiotics despite a viral etiology in most cases. Our objectives were to determine whether rapid respiratory pathogen (RRP) testing decreases antibiotic and health care utilization among children evaluated in the ED with a respiratory illness. Methods We conducted a randomized controlled trial among children 1 mo-18 yrs of age attending an ED with influenza like illness (ILI). All children received a nasopharyngeal swab for RRP testing, and were randomized to the intervention group (result given to providers and parents) or control group (result not given, routine clinical care). Families were interviewed on enrollment, 1 and 10 days later. The primary outcome was antibiotic use. Secondary outcomes included antiviral use, hospitalization and recurrent medical visits. Intention to treat (ITT) (assigned group) and pragmatic (provider knows test results) analyses were conducted using SAS v 9.4. Pragmatic analyses were adjusted using multivariable Poisson regression. Results Among 920 visits (890 children) with ILI, 795 (85%) were RRP positive. Sociodemographic characteristics between groups were similar; 37% of children in the intervention group were discharged before results were available and 12% of children in the control group underwent clinical testing. The median age was 2.1 yrs (IQR 0.88–5.6); 35% had high-risk comorbidities. In the ITT intervention group, children were more likely to receive antibiotics (RR 1.3, 95% CI 1.0–1.7) (Table 1). In adjusted pragmatic analyses, children with known results were more likely to receive antivirals (RR 2.6 95% CI 1.5–4.3) and be hospitalized (RR 2.0, 95% CI 1.5–2.7); antibiotic use was not significant (Table 2). Children testing negative for a virus were more likely to receive antibiotics than those with a virus (35% vs 23%, p = 0.01). Table 1. Clinical Outcomes by Study Arm, Intention to Treat Analyses Table 2. Clinical Outcomes by Study Arm, Pragmatic Analyses Conclusion Knowledge of testing led to a paradoxical increase in antibiotic prescribing, as well as an increase in appropriate antiviral prescribing, ED length of stay and hospitalization. Further studies are needed to assess whether RRP testing with faster turn around times or coupled with stewardship interventions may impact outcomes. Disclosures Suchitra Rao, MD, BioFire (Grant/Research Support) Molly Lamb, PhD, BioFire (Grant/Research Support) Rakesh Mistry, MD, MSCE, BioFire (Grant/Research Support) Samuel Dominguez, MD, PhD, BioFire (Consultant, Research Grant or Support)

scholarly journals A Tailored Advice Tool to Prevent Injuries Among Novice Runners: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Ellen Kemler ◽  
Vincent Gouttebarge
Keyword(s):  
Randomized Controlled Trial ◽  
Injury Prevention ◽  
Preventive Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Prevention Measures ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
And Control

BACKGROUND Besides the beneficial health effects of being active, running is associated with a risk of sustaining injuries. Runners need to change their behavior to increase the use of effective measures and subsequently reduce the number of running-related injuries. OBJECTIVE The RunFitCheck intervention was developed according to an evidence- and practice-based approach to stimulate injury-preventive behavior among novice runners. This paper describes the study design in detail. METHODS A randomized controlled trial with a follow-up period of 5 months will be conducted. The participants will be novice runners. At enrollment, participants will be asked to report injury-preventive measures they usually take during their running activities. After completing the enrollment questionnaire, participants will be randomized to intervention and control groups. The intervention group will have access to the RunFitCheck intervention; the control group will perform their running activities as usual. Participants will be asked to report retrospectively in detail what they have done regarding injury prevention during their running activities at 1, 3, and 5 months after enrollment. Descriptive analyses will be conducted for different baseline variables in the intervention and control group. Relative risks and 95% CIs will be used to analyze behavioral changes according to the intention-to-treat principle. RESULTS The project was funded in 2016 and enrollment was completed in 2017. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. CONCLUSIONS To nullify the negative side effects of running, prevention of training errors is desirable. As the use of injury prevention measures is not compulsory in running, a behavioral change is necessary to increase the use of effective injury-preventive measures and to prevent running-related injuries. CLINICALTRIAL Netherlands Trial Register NTR6381; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6381 (Archived by WebCite at http://www.webcitation.org/736Xjm5jv) INTERNATIONAL REGISTERED REPOR RR1-10.2196/9708

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