Mandibular Growth StimulationPhase 1NCT06409923
Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With KLass II Malocclusion
A Phase 1 study testing Stimulation of mandibular growth. in people with Mandibular Growth Stimulation, run by Université Libre de Bruxelles at 2 sites in Belgium.
Trial summary
This study aims to determine and compare the precise skeletal dental and soft tissue effect of Mandibular advancement aligners and Herbst Appliance. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Growth Stimulation
- What is being tested?
- Stimulation of mandibular growth.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- 14 Feb 2024to 10 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ANB greater than 4°.
- Angle Class II molar and canine relationship
- cervical vertebral maturation (CVM) CVM2/CVM3
Who cannot join
- CVM> 4
- periodontal disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
Université LIbre de Bruxelles
Anderlecht, 1070
paul-henry casselman, +32472424640, paul-henry.casselman@hubruxelles.be
- Recruiting
UNiversité Libre de Bruxelles
Brussels, 1070
Paul-Henry casselman, Master, +32472424640, paul-henry.casselman@hubruxelles.be
+32472424640
About this study
Official title: Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With KLass Malocclusion
This study aims to determine and compare the precise skeletal dental and soft tissue effect of Mandibular advancement aligners and Herbst Appliance.
Read the 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
- Being tested
- Stimulation of mandibular growth.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation of mandibular growth.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
| Study group | Role | What they receive |
|---|---|---|
| Invisalign MA- group (mandibular advancement) | Active comparator | Patients treated by MA aligner system of invisalign Receives: Device: Stimulation of mandibular growth. |
| Herbst group | Active comparator | Patient treated with the herbst appliance Receives: Device: Stimulation of mandibular growth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular lenghtening
Measured: Difference between T1/T2. T1: Before Mandibular advancement phase, T2: Minimum 1 year after T1 and 2 months without mandibular advancement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start14 Feb 2024
- Primary completion10 Sep 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular Growth StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul-Henry Casselman, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409923
- Sponsor's protocol ID
- SRB2023175
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With KLass Malocclusion
- ClinicalTrials.gov ID
- NCT06409923
- Acronym / sponsor ID
- SRB2023175
- Conditions
- Mandibular Growth Stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invisalign MA- group (mandibular advancement) | Active comparator | Device: Stimulation of mandibular growth.Patients treated by MA aligner system of invisalign |
| Herbst group | Active comparator | Device: Stimulation of mandibular growth.Patient treated with the herbst appliance |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ANB greater than 4°.
- Angle Class II molar and canine relationship
- cervical vertebral maturation (CVM) CVM2/CVM3
Key exclusion criteria (2 listed)
- CVM> 4
- periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Herbst group, Invisalign MA- group (mandibular advancement) |
Primary outcome
Mandibular lenghtening
Time frame: Difference between T1/T2. T1: Before Mandibular advancement phase, T2: Minimum 1 year after T1 and 2 months without mandibular advancement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stimulation of mandibular growth. in people with Mandibular Growth Stimulation, run by Université Libre de Bruxelles at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular lenghtening (time frame: Difference between T1/T2. T1: Before Mandibular advancement phase, T2: Minimum 1 year after T1 and 2 months without mandibular advancement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.