Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409923
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-09
Brief Title:
Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With KLass II Malocclusion
Sponsor:
Université Libre de Bruxelles
Organization:
Université Libre de Bruxelles
Study Overview
Official Title:
Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With KLass Malocclusion
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ULBs 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 CVM2CVM3 cervical vertebral maturation
Informed consent forms in the patients 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 premolars 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 89 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
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 ULBs 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 CVM2CVM3 cervical vertebral maturation
Informed consent forms in the patients 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 premolars 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 89 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None