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Mandibular response after rapid maxillary expansion in class II growing patients: a pilot randomized controlled trial.

ABSTRACT: The aim of this pilot randomized controlled trial (RCT) was to evaluate the sagittal mandibular response induced by rapid maxillary expansion (RME) therapy in mixed dentition patients with class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated class II control group.This RCT was designed in parallel with an allocation ratio of 1:1:1. The sample consisted of 30 children with a mean age of 8.1 ± 0.6 years who were randomly assigned to three groups: group 1 treated with bonded RME, group 2 treated with banded RME, and group 3 the untreated control group. All patients met the following inclusion criteria: early mixed dentition, class II molar relationship, transverse discrepancy ??4 mm, overjet ??5 mm, and prepubertal skeletal maturity stage (CS1-CS2). The expansion screw was activated one quarter of a turn per day (0.25 mm) until overcorrection was reached. For each subject, lateral cephalograms and plaster casts were obtained before treatment (T1) and after 1 year (T2). A randomization list was created for the group assignment, with an allocation ratio of 1:1:1. The observer who performed all the measurements was blinded to group assignment. The study was single-blinded in regard to statistical analysis.RME was effective in the correction of maxillary deficiency. Class II patients treated with both types of RME showed no significant improvement of the anteroposterior relationship of the maxilla and the mandible at both skeletal and occlusal levels. The acrylic splint RME had significant effects on reducing the skeletal vertical dimension and the gonial angle.The orthopedic expansion did not affect the sagittal relationship of class II patients treated in the early mixed dentition when compared with the untreated control group. Additional studies with a larger sample are warranted to elucidate individual variations in dento-skeletal mandibular response to the maxillary expansion protocol in class-II-growing patients.ClinicalTrials.gov NCT03159962 .

SUBMITTER: Lione R

PROVIDER: S-EPMC5673058 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Mandibular response after rapid maxillary expansion in class II growing patients: a pilot randomized controlled trial.

Lione Roberta R Brunelli Valerio V Franchi Lorenzo L Pavoni Chiara C Quiroga Souki Bernardo B Cozza Paola P

Progress in orthodontics 20171106 1

<h4>Background</h4>The aim of this pilot randomized controlled trial (RCT) was to evaluate the sagittal mandibular response induced by rapid maxillary expansion (RME) therapy in mixed dentition patients with class II malocclusion, comparing the effects of bonded RME and banded RME with a matched untreated class II control group.<h4>Methods</h4>This RCT was designed in parallel with an allocation ratio of 1:1:1. The sample consisted of 30 children with a mean age of 8.1 ± 0.6 years who were rando ...[more]

PMID: 29105023

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Project description:BackgroundPushing Splints 3 (PS3) device was recently introduced for the treatment of Class III malocclusion in children.ObjectivesTo assess the effect on the sagittal maxillary position (SNA, primary outcome) of PS3 therapy compared with rapid maxillary expansion and facemask therapy (RME/FM) and to compare skeletal and dento-alveolar effects in growing Class III patients.Trial designThis trial was a single-centre randomized controlled trial with two groups randomly allocated in a 1:1 ratio of equal size by sealed-envelope randomization, conducted at the Dentistry Unit of Bambino Gesù Children's Hospital, IRCCS (Rome, Italy).MethodsA total of 48 patients with Class III malocclusion were included in the study and randomly allocated to the two groups: PS3 therapy and RME/FM therapy. Only the RME/FM group underwent palatal expansion, and both groups were instructed to wear the appliances 14 hours/day. Pre- (T0) and post-treatment (T1) cephalograms were taken. An independent sample t-test and regression analysis were used to analyse the data (P value <0.05). Researchers involved in statistics and tracings were blinded to the treatment allocation.ResultsA total of 42 patients (21 for each group) completed the study. The maxillary sagittal position improved similarly in both groups (SNA = 0.4°; P = 0.547). A statistically significant decrease of SNPg angle (-1.6°; P < 0.001) and increase of ANPg angle (1.4°; P = 0.018) were found in the RME/FM group compared with PS3 group. CoGoMe angle significantly decreased in RME/FM group compared with PS3 group (-1.7°; P = 0.042). The regression analysis showed an association between SN/MP angle at T0 and the differences between T1 and T0 of SNPg (B = 0.13; P = 0.005) and SN/MP (B = -0.19; P = 0.034). Only three patients (PS3 = 2; RME/FM = 1) had breakages of the devices.LimitationsResults are limited to short-term effects.ConclusionRME/FM therapy and PS3 are both effective therapies for the early correction of Class III malocclusion. The PS3 controlled better mandibular divergency reducing the clockwise rotation in patients with higher mandibular inclination.RegistrationThis study was not registered in a clinical trial registry.

Project description:INTRODUCTION:Children exposed to secondhand smoke (SHS) are at increased risk of respiratory illnesses. We piloted a Smoke Free Intervention (SFI) and trial methods before investigating its effectiveness and cost-effectiveness in primary school children. METHODS:In a pilot cluster randomized controlled trial in Bangladesh, primary schools were allocated to usual education (control) or SFI, using minimization. Year-5 children were recruited. Masking treatment allocation was not possible. Delivered by schoolteachers, SFI consisted of two 45-min and four 15-min educational sessions. Our primary outcome was SHS exposure at two months post randomization, verified by children's salivary cotinine. The trial is registered at ISRCTN.com; ISRCTN68690577. RESULTS:Between April 1, 2015 and June 30, 2015, we recruited 12 schools. Of the 484 children present in Year-5, 481 consented. Six schools were allocated to both SFI (n = 245) and to usual education only (n = 236). Of them, 450 children (SFI = 229; control = 221) who had cotinine levels indicative of SHS exposure were followed-up. All schools were retained, 91% children (208/229) in SFI and 88% (194/221) in the control arm completed primary outcome assessment. Their mean cotinine at the cluster level was 0.53 ng/ml (SD 0.36) in SFI and 1.84 ng/ml (SD 1.49) in the control arm-a mean difference of -1.31 ng/ml (95% CI = -2.86 to 0.24). CONCLUSION:It was feasible to recruit, randomize, and retain primary schools and children in our trial. Our study, though not powered to detect differences in mean cotinine between the two arms, provides estimates to inform the likely effect size for future trials. IMPLICATIONS:In countries with high smoking prevalence, children remain at risk of many conditions due to secondhand smoke exposure. There is little empirical evidence on the effectiveness and cost-effectiveness of interventions that can reduce their exposure to secondhand smoke at homes. CLASS II trial found that a school-based intervention (SFI) has the potential to reduce children's exposure to SHS-an approach that has been rarely used, but has considerable merit in school-based contexts. CLASS II trial provides key information to conduct a future definitive trial in this area of public health, which despite its importance has so far received little attention.

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Mandibular response after rapid maxillary expansion in class II growing patients: a pilot randomized controlled trial.

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Mandibular response after rapid maxillary expansion in class II growing patients: a pilot randomized controlled trial.

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