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Braces study to test which separator hurts less

NCT ID NCT07591454

Symptom relief Sponsor: 3D-Aligners 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare two types of tooth separators—elastomeric and nickel-titanium—used before placing orthodontic bands for braces. Thirty patients with crowded teeth will have one separator type on each side of their mouth. Researchers will measure how well they create space, how much pain patients feel, and any gum inflammation over three days.

What this could mean

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

Active substance
Elastomeric separators and Nickel-Titanium separators
What this could lead to
If successful, this could help orthodontists choose a separator type that causes less pain and gum irritation for patients getting braces.
What could go wrong
This is a small, early-stage trial with only 30 participants, so results may not apply to everyone. The study hasn't started yet, and findings may not change current practice.

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.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

16 to 25 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: * Class I skeletal and dental malocclusion. * No history of previous orthodontic treatment. * All permanent teeth in both arches, except third molars. * Good oral hygiene and periodontal health. * Good interproximal tooth contacts at the site of separator placement as * checked by interdental floss. * No caries or restorations on the proximal surfaces of first and second permanent molars, and second premolars. Exclusion Criteria: * Patients presenting with restorations or carious lesions on the proximal surfaces of the first or second molars or the second premolars. * Patients with uncontrolled gingival or periodontal inflammation. * Patients with a history of previous orthodontic treatment. * Patients are skeletally classified as Class II or Class III. * Patients are currently using opioid analgesics or have chronic pain conditions requiring regular analgesic intake.

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Conditions

The condition(s) this trial relates to.

Crowding gingivitis Malocclusion, Angle Class I

As listed by the trial registrant

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

Dental crowding Malocclusion, angle class I

How to take part

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

  1. 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 ↗

  2. 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.

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