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Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects

NCT03159962 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-19

No results posted yet for this study

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

Conditions

  • Malocclusion, Angle Class II
  • Malocclusion

Interventions

DEVICE

Bonded RME (Rapid Maxillary Expander) appliance

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.

DEVICE

Banded RME (Rapid Maxillary Expander) appliance

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.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Roberta Lione, Dentistry · Research Fellow, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy, and research Fellow, Department of Dentistry, University Nostra Signora del Buon Consiglio, Tirana, Albania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-11-30
Completion
2016-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159962 on ClinicalTrials.gov