3D printed jaw brace could fix Children's bite without surgery

NCT ID NCT07710391

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 17, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This trial tests a new 3D printed dental appliance designed to correct an underdeveloped upper jaw in children aged 8-13 with class III malocclusion (where the lower jaw sticks out). The device, called a reverse twin block, is worn in the mouth to gently guide jaw growth over six months. Researchers will compare the 3D printed version to a conventional one to see if it improves jaw alignment, comfort, and oral health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a 3D printed reverse twin block appliance
What this could lead to
If effective, this 3D printed device could offer a more precise and comfortable way to correct jaw alignment in growing children, potentially reducing the need for more invasive surgery later.
What could go wrong
This is a small, early-stage trial with only 30 participants, so results may not apply to everyone. The device is new and its long-term benefits or risks compared to standard care are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 13 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth. 2. Presence of permanent first molar with lower anterior teeth to retain the appliance. 3. Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm. b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2. 4. Prescence of unilateral or bilateral posterior crossbite. 5. Mild to moderate anterior crowding. 6. Acceptable oral hygiene baseline defined by oral hygiene index (OHI). - Exclusion Criteria: 1. Patients with cleft lip and palate and/or craniofacial anomalies. 2. History of previous orthopedic and/or orthodontic treatment. 3. Presence of uncontrolled systemic disease or medically compromised status. 4. Uncooperative patient/parents.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • Collage of Dentistry, University of Baghdad

    RECRUITING

    Baghdad, Iraq

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