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Can a light device at home tame implant gum disease?

NCT ID NCT06017817

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether a home-use antibacterial light device, called Lumoral, can help manage peri-implantitis—an infection and inflammation around dental implants. Participants with deep pockets and bone loss around implants will use the device alongside standard oral hygiene and professional cleaning. The study measures changes in bleeding and inflammatory markers to see if the light treatment improves gum health and supports implant stability.

What this could mean

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

Active substance
Lumoral, an antibacterial photodynamic therapy device for home use
What this could lead to
If effective, this could offer a convenient home-based way to help control peri-implantitis and support long-term implant health.
What could go wrong
This is an early-stage study with a small number of participants, so results may not be conclusive or widely applicable. The device is not a replacement for professional treatment and may not work for everyone.

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 80 people

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

Started

May 2024

Expected to finish

Dec 2026

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

18 to 85 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: * PPD ≥6 mm and marginal bone loss \>3 mm * Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22 * Agreement to participate in the study and to sign a written consent form * Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol Exclusion Criteria: * Presence of any physical limitation or restriction that might restrict Lumoral use * Unwilling to participate in the study * Pregnancy or lactation * Active smoking * Medicated diabetes mellitus (DM) * Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis * Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation * Peri-implant and periodontal treatment within 3 months prior to study participation * Removable major prosthesis or major orthodontic appliance

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Conditions

The condition(s) this trial relates to.

Dental Plaque Peri-Implantitis

As listed by the trial registrant

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

Peri-implantitis Plaque, dental

How to take part

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

  1. The places running it

    1 site. 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

  • Södertandläkarna AB

    RECRUITING

    Stockholm, 11622, Sweden

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