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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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

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 groups in NCT07094841
Study groupRoleWhat they receive
herbst groupExperimentalNot described
Receives: Device: 3D PRINTED herbst appliance
mara groupExperimentalNot described
Receives: Device: 3d printed mara

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. improvement in ANB angle measured on lateral cephalometric radiographs (degrees)

    Measured: 4-5 months

Secondary outcomes (2)
  1. changes in posterior airway space measured in mm using cbct

    Measured: 4 -5 months

  2. 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.

  1. First posted30 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

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)
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

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.

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