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

NCT ID: NCT06409923

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2027-09-10

Brief Summary

This study aims to determine and compare the precise skeletal dental and soft tissue effect of Mandibular advancement aligners and Herbst Appliance.

Detailed Description

Precise description of study methodology.

For each group, a sample of +- 15 patients with class 2 malocclusion aged between 9 and 15 years will be collected for this prospective study who presented for an initial orthodontic consultation between October 2022 and july 20262 at ULB's Erasme Hospital. Each patient will be treated with Invisalign MA or the Herbst appliance by residents of the orthodontic program directed by P. Maria Orellana

Inclusion criteria included a Class II skeletal malocclusion with an ANB greater than 4°; (In the case of a Class 2 Division 2 malocclusion, the retroclined upper incisors will be proclined to obtain an overjet allowing mandibular advancement. If the patient has a transverse deficit, palatal expansion will be performed before treatment with aligners and during treatment in herbst cases.) Class II molar and canine relationship and CVM2/CVM3 cervical vertebral maturation.

Informed consent forms in the patient's native language will be submitted before the start of each treatment.

Only a profile cephalometry will be taken in the patients considered for this study at the time of the initial consultation.

This will avoid unnecessary radiographic exposure, and a panoramic view of each patient will be extracted from a CBCT using the FDA-approved BlueskyBio program.

Aligners or Herbst appliance for orthodontic treatment will be fabricated on the basis of a 3D optical scan (Itero), after which patients will begin treatment.

Levelling of the Spee curve, derotation of (pre)molars and palatal incisors in the case of class 2 division 2 malocclusion will be carried out before the mandibular advancement stage if necessary in the Aligner group.

A full-face ultra-low dose CBCT scan will be performed on all included subjects before the mandibular advancement stage according to a strict protocol by a certified physician. Active mandibular advancement will be continued till a KLass I molar relationship is obtained and will be followed by 2 months without mandibular advancement to allow the mandibular condyles to take a central position in the condylar fossae. After this 2-month period, a second CBCT scan will be performed (T2), with a minimal time interval of one year between the two CBCT scans, using the same protocol.

CBCTs will be acquired using a Promax Mid 90 Kv with settings of 90 kV and 8.9 mAS, and tube current modulation will be used to enable patient-specific dose reduction.

After the second CBCT, orthodontic treatment will be continued until completion, and retention and regular post-treatment follow-up will be scheduled for each patient.

The superposition of CBCT (T1) and (T2) images on the anterior cranial base will be used to determine exact mandibular lengthening, condylar displacement, mandibular rotation and chin displacement using the following methodology described and developed by Hugo. De Clerck in 2009.

Conditions

Mandibular Growth Stimulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Invisalign MA- group (mandibular advancement)

Patients treated by MA aligner system of invisalign

Group Type: ACTIVE_COMPARATOR

Stimulation of mandibular growth.

Intervention Type: DEVICE

orthodontic treatment where a retrognathic mandibula is put into an anterior position to stimulate mandibular growth. This will happen by either the MA-invisalign system or the herbst appliance

Herbst group

Patient treated with the herbst appliance

Group Type: ACTIVE_COMPARATOR

Stimulation of mandibular growth.

Intervention Type: DEVICE

orthodontic treatment where a retrognathic mandibula is put into an anterior position to stimulate mandibular growth. This will happen by either the MA-invisalign system or the herbst appliance

Interventions

Stimulation of mandibular growth.

orthodontic treatment where a retrognathic mandibula is put into an anterior position to stimulate mandibular growth. This will happen by either the MA-invisalign system or the herbst appliance

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ANB greater than 4°.
• Angle Class II molar and canine relationship
• cervical vertebral maturation (CVM) CVM2/CVM3

Exclusion Criteria

• CVM> 4
• periodontal disease

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Libre de Bruxelles

OTHER

Sponsor Role: lead

Responsible Party

Paul-Henry Casselman

Postgraduate student Dentofacial orthopedics and orthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Université LIbre de Bruxelles

Anderlecht, , Belgium

Site Status: RECRUITING

UNiversité Libre de Bruxelles

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

paul-henry casselman

Role: primary

paul-henry.casselman@hubruxelles.be

+32472424640

Paul-Henry casselman, Master

Role: primary

paul-henry.casselman@hubruxelles.be

+32472424640

Role: backup

+32472424640

Other Identifiers

SRB2023175

Identifier Type: -

Identifier Source: org_study_id