Actively Recruiting
Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With Class II Malocclusion
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 treatments—Mandibular advancement aligners (Invisalign MA) and the Herbst appliance—in 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
Eligibility Criteria
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
You will not qualify if you...
- Cervical vertebral maturation stage greater than CVM4
- Presence of periodontal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 1 year including a 2-month period without mandibular advancement after active treatment
Participants receive orthodontic treatment with either the Invisalign MA system or the Herbst appliance to stimulate mandibular growth for Class II malocclusion.
Multiple visits during treatment as required for appliance adjustments and monitoring
Duration - Duration of post-treatment retention and monitoring until treatment completion
After completion of the mandibular advancement phase, participants continue orthodontic treatment until completion, followed by retention and regular post-treatment monitoring.
Regular post-treatment follow-up visits
Trial Site Locations
Total: 2 locations
1
Université LIbre de Bruxelles
Anderlecht, Belgium, 1070
Actively Recruiting
2
UNiversité Libre de Bruxelles
Brussels, Belgium, 1070
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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