Mal Occlusion Class 2NCT07094841
Comparative Study Between Two 3D Functional Appliances Herbst and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space And TMJ in Growing Class II Malocclusion Patients
A study testing 3D PRINTED herbst appliance and 3d printed mara in people with Mal Occlusion Class 2, run by Moataz Sleem Ahmed Ali.
Trial summary
The aim of this study is to evaluate effect of three dimensional printed appliances Herbst appliance and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space (PAS) and Temporomandibular Joint (TMJ) in growing patients with Class II malocclusion. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Mal Occlusion Class 2
- What is being tested?
- 3D PRINTED herbst appliance and 3d printed mara
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jan 2028
- Phase
- Interventional
- 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cvm stage 2-3
- mild to moderate class 2 mal occlusion
- no prior orthodontic treatment
- good oral hygiene
- good patient compliance
Who cannot join
- previous orthodontic treatment
- craniofacial anomlies
- severe crowding
- severe skeletal protrusion
- tmj disorders
- poor compliance
- dental anomales
About this study
Official title: Comparative Study Between The Effect of Three Dimensional Printed Appliances Herbst and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space And Temporomandibular Joint TMJ in Growing Class II Malocclusion Patients (Randomized Clinical Trial)
The aim of this study is to evaluate effect of three dimensional printed appliances Herbst appliance and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space (PAS) and Temporomandibular Joint (TMJ) in growing patients with Class II malocclusion.
Primary outcome:
Effect of three dimensional printed appliances Herbst appliance and Mandibular Anterior Repositioning Appliance (MARA) on Class II malocclusion in growing patients.
Secondary outcome: To evaluate effects of two different three dimensional printed functional appliances on Posterior Airway Space (PAS) and Temporomandibular Joint (TMJ).
Read the detailed description
Class II malocclusion is the most common sagittal skeletal imbalance. It can result from mandibular retrusion, maxillary overgrowth, or a posteriorly positioned glenoid fossa According to McNamara (1981), mandibular skeletal retrusion is the predominant skeletal feature in Class II cases, while maxillary skeletal protrusion is relatively uncommon. Class II malocclusion frequently includes Mandibular retrusion, protruding maxillary incisors, increased overjet, imperfect lip closure, and a higher risk of dental trauma and functional disruptions.
Functional appliances aim to correct functional habits, prevent trauma to protrusive incisors, improve facial esthetics, and stimulate mandibular growth for better occlusal balance and long-term stability during development.
Their primary objective is to stimulate mandibular growth by advancing the mandible into a Class I occlusal relationship, and the expectation is that the condylar processes will remodel superiorly and posteriorly in the condylar fossae. Functional appliances are used during growth.They are classified as removable or fixed, with fixed types including rigid, hybrid, and flexible designs. Studies have indicated that rigid fixed functional appliances yield the most effective results in growing patients.
Patient compliance is a critical factor influencing the effectiveness of functional appliances. so, it is important to evaluate removable and fixed appliances separately to accurately assess their clinical efficacy and identify any differences in treatment outcomes. The mandibular anterior repositioning appliance (MARA) is a functional device used to correct Class II malocclusion by repositioning the mandibular condyles anteriorly and inferiorly, promoting remodeling of the condyles and temporal fossae.
The Herbst appliance is a rigid fixed functional device used for Class II correction and is effective over a short treatment period of six to eight months. It functions as an artificial joint by advancing the mandible forward, inducing a "bite-jumping" effect. it has been shown to produce stable and favorable dentoskeletal effects in the correction of Class II malocclusion Additive manufacturing (AM) is a technique for producing three-dimensional (3D) objects by layering materials. Initially introduced in 1980, the process begins with a 3D design that is sliced into cross sections and transmitted to a 3D printer.. This technology is widely applied in medical fields, such as dental and orthodontic appliances. The posterior airway space (PAS), located between the posterior pharyngeal wall and the base of the tongue or soft palate, is part of the extrathoracic airway. A reduced PAS is linked to conditions such as obstructive sleep apnea (OSA) and snoring, Mandibular hypoplasia can present with a range of clinical symptoms, from minor aesthetic concerns to functional impairments and OSA.
The temporomandibular joint (TMJ) is a complex joint that facilitates mandibular movement and adapts structurally in response to external factors such as age, muscle activity, and occlusal forces.
This study aims to explore and compare the impact of these two 3D-printed appliances on the posterior airway space and TMJ structures, providing insight into their relative effectiveness in improving both skeletal and functional outcomes during growth modification
- Conditions
- Mal Occlusion Class 2
- Being tested
- 3D PRINTED herbst appliance, 3d printed mara
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D PRINTED herbst applianceDevice
participants will receive treatment with herbst appliance for 4 to 5 months
3d printed maraDevice
participants will receive treatment with mara appliance for 4 to 5 months
| Study group | Role | What they receive |
|---|---|---|
| herbst group | Experimental | Not described Receives: Device: 3D PRINTED herbst appliance |
| mara group | Experimental | Not described Receives: Device: 3d printed mara |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in ANB angle measured on lateral cephalometric radiographs (degrees)
Measured: 4-5 months
Secondary outcomes (2)
changes in posterior airway space measured in mm using cbct
Measured: 4 -5 months
changes in TMJ measured in mm using cbct
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mal Occlusion Class 2Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moataz Sleem Ahmed Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moataz Sleem Ahmed Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094841
- Sponsor's protocol ID
- 3D Herbst Mara- c2 RCT 2025
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between The Effect of Three Dimensional Printed Appliances Herbst and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space And Temporomandibular Joint TMJ in Growing Class II Malocclusion Patients (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07094841
- Acronym / sponsor ID
- 3D Herbst Mara- c2 RCT 2025
- Conditions
- Mal Occlusion Class 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Moataz Sleem Ahmed AliUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 30 Jul 2025 (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.
The aim of this study is to evaluate effect of three dimensional printed appliances Herbst appliance and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space (PAS) and Temporomandibular Joint (TMJ) in growing patients with Class II malocclusion.
Primary outcome:
Effect of three dimensional printed appliances Herbst appliance and Mandibular Anterior Repositioning Appliance (MARA) on Class II malocclusion in growing patients.
Secondary outcome: To evaluate effects of two different three dimensional printed functional appliances on Posterior Airway Space (PAS) and Temporomandibular Joint (TMJ).
Detailed description
Class II malocclusion is the most common sagittal skeletal imbalance. It can result from mandibular retrusion, maxillary overgrowth, or a posteriorly positioned glenoid fossa According to McNamara (1981), mandibular skeletal retrusion is the predominant skeletal feature in Class II cases, while maxillary skeletal protrusion is relatively uncommon. Class II malocclusion frequently includes Mandibular retrusion, protruding maxillary incisors, increased overjet, imperfect lip closure, and a higher risk of dental trauma and functional disruptions.
Functional appliances aim to correct functional habits, prevent trauma to protrusive incisors, improve facial esthetics, and stimulate mandibular growth for better occlusal balance and long-term stability during development.
Their primary objective is to stimulate mandibular growth by advancing the mandible into a Class I occlusal relationship, and the expectation is that the condylar processes will remodel superiorly and posteriorly in the condylar fossae. Functional appliances are used during growth.They are classified as removable or fixed, with fixed types including rigid, hybrid, and flexible designs. Studies have indicated that rigid fixed functional appliances yield the most effective results in growing patients.
Patient compliance is a critical factor influencing the effectiveness of functional appliances. so, it is important to evaluate removable and fixed appliances separately to accurately assess their clinical efficacy and identify any differences in treatment outcomes. The mandibular anterior repositioning appliance (MARA) is a functional device used to correct Class II malocclusion by repositioning the mandibular condyles anteriorly and inferiorly, promoting remodeling of the condyles and temporal fossae.
The Herbst appliance is a rigid fixed functional device used for Class II correction and is effective over a short treatment period of six to eight months. It functions as an artificial joint by advancing the mandible forward, inducing a "bite-jumping" effect. it has been shown to produce stable and favorable dentoskeletal effects in the correction of Class II malocclusion Additive manufacturing (AM) is a technique for producing three-dimensional (3D) objects by layering materials. Initially introduced in 1980, the process begins with a 3D design that is sliced into cross sections and transmitted to a 3D printer.. This technology is widely applied in medical fields, such as dental and orthodontic appliances. The posterior airway space (PAS), located between the posterior pharyngeal wall and the base of the tongue or soft palate, is part of the extrathoracic airway. A reduced PAS is linked to conditions such as obstructive sleep apnea (OSA) and snoring, Mandibular hypoplasia can present with a range of clinical symptoms, from minor aesthetic concerns to functional impairments and OSA.
The temporomandibular joint (TMJ) is a complex joint that facilitates mandibular movement and adapts structurally in response to external factors such as age, muscle activity, and occlusal forces.
This study aims to explore and compare the impact of these two 3D-printed appliances on the posterior airway space and TMJ structures, providing insight into their relative effectiveness in improving both skeletal and functional outcomes during growth modification
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| herbst group | Experimental | Device: 3D PRINTED herbst appliance |
| mara group | Experimental | Device: 3d printed mara |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- cvm stage 2-3
- mild to moderate class 2 mal occlusion
- no prior orthodontic treatment
- good oral hygiene
- good patient compliance
Key exclusion criteria (7 listed)
- previous orthodontic treatment
- craniofacial anomlies
- severe crowding
- severe skeletal protrusion
- tmj disorders
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 |
|---|---|---|
| 3D PRINTED herbst applianceparticipants will receive treatment with herbst appliance for 4 to 5 months | Device | herbst group |
| 3d printed maraparticipants will receive treatment with mara appliance for 4 to 5 months | Device | mara group |
Primary outcome
improvement in ANB angle measured on lateral cephalometric radiographs (degrees)
Time frame: 4-5 months
2 secondary outcomes
changes in posterior airway space measured in mm using cbct
Time frame: 4 -5 months
changes in TMJ measured in mm using cbct
Time frame: 4-5 months
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 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3D PRINTED herbst appliance and 3d printed mara in people with Mal Occlusion Class 2, run by Moataz Sleem Ahmed Ali.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in ANB angle measured on lateral cephalometric radiographs (degrees) (time frame: 4-5 months). 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 30 Jul 2025.