Is Taping Alone an Efficient Presurgical Infant Orthopedic Approach in Infants With Unilateral Cleft Lip and Palate? A Randomized Controlled Trial

2020 ◽  
Vol 57 (12) ◽  
pp. 1382-1391
Author(s):  
Mohamed Abd El-Ghafour ◽  
Mamdouh A. Aboulhassan ◽  
Amr Ragab El-Beialy ◽  
Mona M. Salah Fayed ◽  
Faten Hussein Kamel Eid ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Controlled Trial ◽  
Control Group ◽  
Digital Models ◽  
Randomized Controlled ◽  
Outcomes Measures ◽  
Parallel Group ◽  
Blinded Assessor

Objective: The aim of the current randomized controlled trial (RCT) was to assess the effectiveness of taping alone in changing the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. Design: A prospective, balanced, randomized, parallel-group, single-blinded, controlled trial. Setting: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. Participants: Thirty-one, nonsyndromic infants with UCLP. Interventions: The eligible infants were randomly assigned to either no-treatment (control) or taping groups. In the taping group, all the infants received horizontal tape between the 2 labial segments aiming to decrease the cleft gap. No other interventions were performed to infants included in this group. Rubber base impressions were made to all the included infants in both groups at the beginning of the treatment (T1) and directly before surgical lip repair (T2). All the produced models were scanned using a desktop scanner producing digital models for outcome assessment. Main Outcomes Measures: A blinded assessor carried out all the MAD measurements virtually on the produced digital models at the beginning (T1) and after (T2) treatment. Results: Clinically and/or statistically significant changes in all the measured MADs were recorded in the taping group at T2 before surgical lip repair in comparison to the control group. Conclusions: It seems that taping alone is an efficient tool in changing the MADs before surgical lip repair in infants with UCLP.

Effectiveness of a Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

2020 ◽  
Vol 57 (12) ◽  
pp. 1370-1381
Author(s):  
Mohamed Abd El-Ghafour ◽  
Mamdouh A. Aboulhassan ◽  
Mona M. Salah Fayed ◽  
Amr Ragab El-Beialy ◽  
Faten Hussein Kamel Eid ◽  
...  
Keyword(s):  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcomes Measures ◽  
Virtual Appliance ◽  
3D Printed ◽  
Nasoalveolar Molding ◽  
Maxillary Arch

Objective: The aim of the current study was to introduce and measure the effectiveness of a new 3D-printed nasoalveolar molding (D-NAM) appliance on improving the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. Design: A prospective, balanced, randomized, parallel groups, single-blinded, controlled trial. Setting: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. Participants: Thirty-four, nonsyndromic infants with UCLP. Interventions: The eligible infants were randomly assigned into either no-treatment (control) or to the new D-NAM groups. In D-NAM group, the maxillary models were 3D scanned into virtual models onto which segmentation and alveolar segments approximation were performed. Approximation movements were divided into 3 models representing 3 activation steps. On each of these models, virtual appliance construction was performed followed by 3D printing of the appliance. Nasal stent was added manually to the appliances of the second and third steps. Horizontal tapes were applied to infants in the D-NAM group only. Main Outcomes Measures: A Blinded assessors carried all the MADs measurements virtually on digital models collected at the beginning (T1) and after (T2) treatment. Results: Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group. Conclusions: The introduced D-NAM/3D-printed appliance is a simple and efficient technique to improve the MADs in infants with UCLP before surgical lip repair.

scholarly journals The Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet on Metabolic Syndrome in Hospitalized Schizophrenic Patients: A Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2950 ◽  
Author(s):  
Tamara Sorić ◽  
Mladen Mavar ◽  
Ivana Rumbak
Keyword(s):  
Metabolic Syndrome ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Dash Diet ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Schizophrenic Patients ◽  
The Relationship

The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and metabolic syndrome (MetS) in people with schizophrenia is unknown and remains to be investigated. Therefore, we have conducted a three-month parallel-group randomized controlled trial. Sixty-seven hospitalized schizophrenic patients with MetS [n = 33 in the intervention group (IG) and n = 34 in the control group (CG)] completed the intervention. The IG followed the DASH diet with the caloric restriction of approximately 1673.6 kJ/day (400 kcal/day) when compared to the standard hospital diet followed by the CG. Simultaneously, both groups participated in a nutrition counseling program. Anthropometric and biochemical parameters and blood pressure were measured at the baseline and after three months, while nutrient intakes during the intervention were assessed using three non-consecutive 24-hour dietary recalls. The analyses were carried out based on the per-protocol approach. At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%, p = 0.002, and 67.7%, p = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43–1.87). No significant differences in the prevalence of MetS and its features were found between the groups.

scholarly journals Retraining for prevention of peritonitis in peritoneal dialysis patients: A randomized controlled trial

2020 ◽  
Vol 40 (2) ◽  
pp. 141-152
Author(s):  
Susanne Ljungman ◽  
Jørgen E Jensen ◽  
Dag Paulsen ◽  
Aivars Petersons ◽  
Mai Ots-Rosenberg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Statistical Error ◽  
Control Group ◽  
Infection Prophylaxis ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Targeted Testing

Background: Peritonitis is more common in peritoneal dialysis (PD) patients nonadherent to the PD exchange protocol procedures than in compliant patients. We therefore investigated whether regular testing of PD knowledge with focus on infection prophylaxis could increase the time to first peritonitis (primary outcome) and reduce the peritonitis rate in new PD patients. Methods: This physician-initiated, open-label, parallel group trial took place at 57 centers in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom from 2010 to 2015. New peritonitis-free PD patients were randomized using computer-generated numbers 1 month after the start of PD either to a control group ( n = 331) treated according to center routines or to a retraining group ( n = 340), which underwent testing of PD knowledge and skills at 1, 3, 6, 12, 18, 24, 30, and 36 months after PD start, followed by retraining if the goals were not achieved. Results: In all, 74% of the controls and 80% of the retraining patients discontinued the study. The groups did not differ significantly regarding cumulative incidence of first peritonitis adjusted for competing risks (kidney transplantation, transfer to hemodialysis and death; hazard ratio 0.84; 95% confidence interval (CI) 0.65–1.09) nor regarding peritonitis rate per patient year (relative risk 0.93; 95% CI 0.75–1.16). Conclusions: In this randomized controlled trial, we were unable to demonstrate that regular, targeted testing and retraining of new PD patients increased the time to first peritonitis or reduced the rate of peritonitis, as the study comprised patients with a low risk of peritonitis, was underpowered, open to type 1 statistical error, and contamination between groups.

scholarly journals A Randomized Controlled Trial Evaluating a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities Part One: Pain-Related Knowledge and Perceptions

2021 ◽  
Vol 126 (4) ◽  
pp. 271-288 ◽  
Author(s):  
Lara M. Genik ◽  
Elisabeth L. Aerts ◽  
Paula C. Barata ◽  
Chantel C. Barney ◽  
Stephen P. Lewis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Assessment ◽  
Controlled Trial ◽  
Management Program ◽  
Control Group ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Pain Knowledge

Abstract This parallel group randomized controlled trial tested effectiveness of the Let's Talk About Pain training on respite workers' (RW) pain-related knowledge and feasibility-confidence-skill ratings using between-group and within-group analyses. Fourteen children's respite organizations were randomized to pain or control training. Participants (nintervention = 66; ncontrol = 92) underwent a 3–3.5 hour training and completed measures at pre-, post-, and 4–6 week follow-up. Intention-to-treat (nintervention = 65; ncontrol = 92) and per-protocol (nintervention = 26–38; ncontrol = 40–57) analyses were conducted. Pain training participants demonstrated significantly higher pain knowledge and feasibility-confidence-skill ratings post-follow-up versus control group and significant increases in knowledge from pre-post. Significant gains were maintained from post-follow-up. Results represent a promising step towards enhancing pain-related care for children with IDD.

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