CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Bonded RME (Rapid Maxillary Expander) appliance +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03159962
NCT03159962N/ACompleted

Mandibular Response After Rapid Maxillary Expansion in Class II Growing Patients: a Pilot Randomized Controlled Trial

University of Rome Tor Vergata·interventional·Posted May 19, 2017·Updated May 19, 2017

In Brief

A clinical study evaluating Bonded RME (Rapid Maxillary Expander) appliance and Banded RME (Rapid Maxillary Expander) appliance for Malocclusion, Angle Class II and Malocclusion. Completed, enrolled 30 participants across 1 site.

Detailed Summary

the effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group. The primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 19, 2017
Enrollment StartJan 1, 2015
Primary CompletionNov 1, 2015
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.1 years ago

Interventions

Bonded RME (Rapid Maxillary Expander) appliancedevice

The expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth. The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months.

Banded RME (Rapid Maxillary Expander) appliancedevice

The expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth. The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months.