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Modified Herbst Approach to Improve Chin Projection

NCT05597748 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-08-06

No results posted yet for this study

Summary

This study will collect data to try to assess which one of the two management options works better. The first option involves the use of the bite corrector first and then braces, while the second option involves the temporary addition of small support bone screws with the bite corrector later and then braces. Currently, it is not clearly known if there are important differences between the proposed management options. Such approaches are conventionally used in orthodontic practices. The information collected in this study will be used to compare the differences in the nature of the facial, teeth, and bone changes after the treatment. Questions about the experience while using the devices will be asked.

Conditions

  • Class II Malocclusion

Interventions

DEVICE

Modified Herbst Approach

A modified hybrid Herbst appliance approach (same hybrid Herbst appliance approach but with the addition of temporary anchorage devices (TADs) in both arches) will be used (alternative treatment). In the upper arch, the TADs would be inserted in the paramedical palatal area. In the lower arch, they would be inserted buccally between the roots of the lower second premolar and the first permanent molar. Elastomeric chains will be used to link these TADs to the first molars in the upper arch and to a buccal bottom on the lower canines. Upper brackets will be initially bonded and upper incisors proclined until normal inclination values are attained.

DEVICE

Conventional Herbst Approach

A hybrid Herbst appliance approach will be used (current available conventional treatment). The upper jaw component will be a maxillary expander secured on the first molar bands. The lower arch would have an uncemented lower acrylic full-coverage splint-type. In between Herbst-type pistons will be used.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Carlos Flores Mir, DSc · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Canada

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 NCT05597748 on ClinicalTrials.gov