CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Herbst appliancedevice
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/NCT02456220
NCT02456220N/ACompleted

Three-dimensional Assessment of the Dentoskeletal Changes Associated With Herbst Appliance Therapy: A Controlled Clinical Trial

Bernardo Quiroga Souki·interventional·Posted May 28, 2015·Updated Oct 27, 2015

In Brief

A clinical study evaluating Herbst appliance for Malocclusion, Angle Class II. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2015
Enrollment StartMar 1, 2013
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.1 years ago

Interventions

Herbst appliancedevice

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