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Clear aligner color showdown: straight edge vs. Gum-Hugging design

NCT ID NCT07628491

Knowledge-focused Sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 4 times

Summary

This study looks at whether the edge design of clear orthodontic aligners changes how much they discolor after 14 days of wear. Fifty people in the final stage of aligner treatment will wear aligners with two different gumline designs—one straight and one following the gum curve—on different jaws. Their color is measured at the start and after two weeks to see which design stays clearer.

What this could mean

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

Active substance
Tri-layer thermoplastic finishing clear aligner (device)
What this could lead to
If successful, this could help orthodontists choose aligner designs that stay clearer and more aesthetic during treatment.
What could go wrong
This is a small, early-stage study (50 people) looking only at color change, not overall treatment success. Results may not apply to all aligner brands or longer wear times.

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

50 people

The number who actually took part.

Started

Jun 2026

Finished

Jul 2026

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

15 years and older

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: * Adolescent and adult patients (age 15 years or older at enrollment) * Undergoing a finishing (refinement) stage of clear aligner therapy, with only small residual tooth movements remaining, including both patients completing active orthodontic treatment and patients with prior orthodontic treatment who require additional refinement (e.g., minor relapse or loss of retention) * Adherence to the prescribed oral hygiene instructions * Written informed consent; for participants aged 15-17 years, written consent from a parent or legal guardian Exclusion Criteria: * Deficient oral hygiene * Excessive consumption of intensely staining beverages (coffee, tea, red wine, colored carbonated drinks) * Systemic conditions or medications that may affect salivary secretion or tooth color * Non-compliance with the aligner / orthodontic appliance wear protocol

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Conditions

The condition(s) this trial relates to.

Malocclusion

As listed by the trial registrant

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

Esthetics, dental Malocclusion

Contacts and locations

Locations

  • Aorys Clinic

    Sibiu, Sibiu County, 550118, Romania

More trials for these conditions

Other studies related to the condition(s) this trial covers.