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New light device aims to zap plaque in teens with braces

NCT ID NCT05825742

Disease control Sponsor: Koite Health Oy 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a special light device used at home can improve oral health in teenagers with braces. Forty teens used the device daily for two months, while others received standard brushing instructions. The goal was to see if the device reduces plaque and gum bleeding, which are common problems during orthodontic treatment.

What this could mean

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

Active substance
Lumoral treatment device (dual-light photodynamic therapy)
What this could lead to
If effective, this device could offer a simple at-home way to reduce plaque and gum problems for teenagers with braces.
What could go wrong
This is a small, completed study with only 40 participants. The device may not work for everyone, and long-term benefits are not yet proven.

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

40 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2025

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

15 to 18 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 of 15-18 years old * starting fixed orthodontic treatment * good oral hygiene according to the dentist's assessment * absence of periodontal disease and lack of oral lesion * signed a written consent form, including information to caregivers. Exclusion Criteria: * any chronic diseases * medications that could influence the study (according to the dentists' assessment) * active caries or a supposed high risk of caries * gingivitis (bleeding on probing \>10%) * use of antiseptic mouthwashes * smoking * use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study * unable to cooperate with the protocol. * pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

Dental Plaque gingivitis

As listed by the trial registrant

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

Gingival inflammation Orthodontic appliance complication Plaque, dental

Contacts and locations

Locations

  • Borgska Villans Specialisttandvård

    Lund, 22355, Sweden

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