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Dentoskeletal Changes Associated With Herbst Appliance Therapy

NCT02456220 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-10-27

No results posted yet for this study

Summary

The aim of the study is to perform a three-dimensional (3D) evaluation of the dentoskeletal changes in pubertal Class II malocclusion subjects treated with the Herbst appliance (HAG), in comparison with a Class II comparison group (CG). 3D virtual models generated from three time-point CBCTs (T0, baseline; T1, immediately after Herbst insertion; and T2, 8 months after) of 25 HAG patients will be evaluated. Virtual models obtained from 25 Class II malocclusion patients, in the same stage of biologic maturation and skeletal abnormality, but with no orthopedic treatment will be constructed for the CG subjects. These CG patients are under orthodontic treatment, but only with teeth alignment. Voxel based registration on the anterior cranial fossa will be used to assess maxillary and mandibular displacement/articular fossa remodeling; regional registration on the mandibular corpus will be performed to evaluate mandibular growth and mandibular dental changes; and regional registration on the anterior region of the maxilla will be performed to evaluate maxillary growth and maxillary dental changes.

Conditions

  • Malocclusion, Angle Class II

Interventions

DEVICE

Herbst appliance

Group treated with conventional Herbst appliance for mandibular advancement during orthopedic treatment.

Sponsors & Collaborators

Principal Investigators

  • Bernardo Q Souki, PhD · Pontifícia Universidade Católica de Minas Gerais

  • James A McNamara Jr., PhD · University of Michigan

  • Lucia Helena S Cevidanes, PhD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • Brazil

Study Locations

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Entities

Companies

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 NCT02456220 on ClinicalTrials.gov