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Phase 1
Age: 0 - 15Years
All Genders
Healthy Volunteers
ID06409923

Study Comparing Herbst Appliance and Invisalign MA Effects on Jaw Growth in Children With Class II Malocclusion Aged 9 to 15

Led by Université Libre de Bruxelles · Updated on 2024-05-10

30

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the skeletal, dental, and soft tissue effects of two orthodontic treatmentsMandibular advancement aligners Invisalign MA and the Herbst appliancein growing patients with Class II malocclusion. The study focuses on children aged 9 to 15 years who have a Class II skeletal malocclusion with specific dental and skeletal characteristics. The goal is to compare how each device stimulates mandibular growth and affects jaw alignment and facial structure. Participants will receive treatment with either the Invisalign MA system or the Herbst appliance. Before treatment, dental impressions and 3D optical scans will be used to create the devices. Some preparatory dental adjustments may be made, such as leveling teeth or expanding the palate when needed. Active mandibular advancement will continue until a Class I molar relationship is achieved, followed by a 2-month period without advancement to allow jaw stabilization. The study includes two CBCT scans taken before and after this phase, spaced at least one year apart, to measure changes precisely. Throughout the study, patients will undergo initial and follow-up dental assessments, including cephalometric X-rays and ultra-low dose CBCT scans. These scans help measure mandibular lengthening, jaw movement, and rotation. After the main treatment phase, orthodontic care will continue until completion, followed by retention and regular post-treatment check-ups. The total study duration per participant is at least one year plus the retention period, ensuring careful monitoring of treatment effects and jaw development.

CONDITIONS

Brief Title

Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With KLass II Malocclusion

Who Can Participate

Age: 0 - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • ANB angle greater than 4°
  • Angle Class II molar and canine relationship
  • Cervical vertebral maturation stage CVM2 or CVM3
  • Age between 9 and 15 years
  • Class II skeletal malocclusion requiring mandibular advancement
Not Eligible

You will not qualify if you...

  • Cervical vertebral maturation stage greater than CVM4
  • Presence of periodontal disease

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