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Which brace works best? new study tests early vs. late treatment for Kids' overbite

NCT ID NCT07404696

Disease control Sponsor: Vastra Gotaland Region 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 This study
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 Results may not be published yet.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.
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will enroll 144 children aged 9-13 with a class II malocclusion (overjet of 6 mm or more) to compare three early orthodontic appliances (headgear-activator, twin block, and Invisalign mandibular advancement) against a control group that receives later fixed braces. Researchers will measure how much the overjet improves, how children feel about their teeth and treatment, and the cost-effectiveness of each approach. The goal is to determine if early interceptive treatment is effective and which method is best.

What this could mean

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

Active substance
orthodontic appliances (headgear-activator, twin block, Invisalign mandibular advancement, fixed appliance)
What this could lead to
If successful, this could show which early orthodontic treatment works best for correcting overjet and improving quality of life in children, potentially guiding standard care.
What could go wrong
This is a relatively small, early-stage trial (144 participants) comparing different devices, so results may not apply broadly. There is also a risk that no single appliance proves clearly superior.

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 144 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

9 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: * Children age 9-13 years at the start of the trial * Mixed dentition, DS3M1 * Excessive overjet ≥6 mm * First permanent molars in at least half cusp Cl II relation bilaterally * Incomplete lip closure Exclusion Criteria: * Treatment needing extractions due to severe crowding * Earlier orthodontic treatment * Mouth breathing * Ongoing sucking habits * Syndromic patients

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Conditions

The condition(s) this trial relates to.

malocclusion due to protuberant upper front teeth Malocclusion, Angle Class II Overbite

As listed by the trial registrant

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

Class II malocclusion Class II malocclusion, division 1 Overjet

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Orthodontic Specialist Clinic

    Halmstad, 30246, Sweden

  • Orthodontic Specialist Clinic

    Kungsbacka, 43441, Sweden

  • Sahlgrenska Academy

    Gothenburg, 40530, Sweden

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