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Clear aligner edge design may influence gum bacteria

NCT ID NCT07533058

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests whether the way a clear aligner's edge meets the gumline changes the types of bacteria living in the gum pocket. 36 people in the finishing phase of orthodontic treatment wore aligners with two different edge designs at the same time—one covering a bit of gum, the other following the gumline exactly. Researchers measured levels of seven gum-disease-related bacteria after 4 and 8 weeks to see if one design promotes more harmful bacteria.

What this could mean

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

Active substance
CA Pro tri-layer finishing clear aligner (SCHEU-DENTAL GmbH)
What this could lead to
If it works, this could help orthodontists choose aligner designs that reduce the risk of gum disease during treatment.
What could go wrong
This is a small, early-stage study (36 people) looking only at bacterial levels, not actual gum disease. Results may not apply to everyone or predict long-term outcomes.

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

36 people

The number who actually took part.

Started

May 2026

Finished

Aug 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: * Permanent dentition (excluding third molars) * Age 15 years or older at enrollment * Currently undergoing the finishing phase of orthodontic treatment with clear aligners * Residual planned tooth movements no greater than 0.5 mm per tooth per aligner stage * Absence of active periodontal disease at baseline: probing depth 3 mm or less at all sites, and no bleeding on probing at index sampling sites * Written informed consent; for participants aged 15-17 years, written consent from parent or legal guardian is also required Exclusion Criteria: * Systemic conditions known to affect periodontal tissues (e.g., uncontrolled diabetes mellitus, immunosuppressive therapy) * Antibiotic therapy within the 3 months preceding enrollment * Active gingivitis (modified gingival index 2 or greater) or periodontitis at baseline * Habitual mouth breathing (self-reported or clinically assessed) * Poorly adapted fixed prosthetic restorations adjacent to planned index sampling sites * Visible plaque at more than 50% of tooth surfaces at baseline * Self-reported aligner compliance below 22 hours per day during the study period * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

Malocclusion periodontal disorder

As listed by the trial registrant

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

Malocclusion Oral health Periodontal diseases

Contacts and locations

Locations

  • Aorys Clinic

    Sibiu, Sibiu County, 550027, Romania

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