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A new device may fix underbites without the facemask

NCT ID NCT07771660

Disease control Sponsor: Ankara University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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.
Expanded access (paused)
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether a new intraoral device, the Ertty Gap III, can correct skeletal Class III malocclusion (underbite) in growing children aged 9–12 as effectively as the standard facemask therapy. The study measures changes in jaw alignment using X-rays before and after treatment, comparing the two approaches. If the new device works, it could offer a less visible and more comfortable option for young patients.

What this could mean

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

Active substance
Ertty Gap III appliance (an intraoral orthopedic device) compared with facemask therapy
What this could lead to
If successful, this could offer a more comfortable or effective alternative to facemask therapy for correcting underbite in children.
What could go wrong
This is a small, early-stage trial with 42 participants, so results may not apply broadly. The device is new and may not outperform the standard facemask.

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

42 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2025

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

9 to 12 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: * Age between 9 and 12 years. * Late mixed or early permanent dentition. * Skeletal Class III malocclusion characterized by an A point-Nasion-B point (ANB) angle ≤ 0° and a Class III molar relationship. * Maxillary deficiency confirmed by clinical and cephalometric assessment, including evaluation of the Sella-Nasion-Point A (SNA) angle according to Steiner analysis (82° ± 2° as the reference) and clinical evidence of perinasal or midfacial deficiency. * In participants with associated mandibular prognathism, maxillary retrognathia was required to be the predominant skeletal component of the Class III discrepancy. * Anterior crossbite or an edge-to-edge incisal relationship. * No previous orthodontic or orthopedic treatment. Exclusion Criteria: * Completed skeletal growth. * Skeletal Class III malocclusion attributable solely to mandibular prognathism without clinical or cephalometric evidence of maxillary retrognathia. * Presence of systemic disease. * Craniofacial syndromes or congenital craniofacial anomalies. * Temporomandibular joint disorders. * Congenital absence of maxillary lateral incisors. * Palatally displaced permanent canines. * Missing, extracted, or prematurely lost permanent first molars.

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Conditions

The condition(s) this trial relates to.

autosomal dominant prognathism

As listed by the trial registrant

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

Skeletal class III malocclusion

Contacts and locations

Locations

  • Ankara University, Faculty of Dentistry, Department of Orthodontics

    Ankara, Ankara, 06560, Turkey (Türkiye)

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