What is the Lumoral treatment studying for peri-implantitis?

The Lumoral treatment is being studied to see if its antibacterial photodynamic therapy can improve plaque control and reduce inflammation in people with peri-implantitis. Researchers aim to evaluate its impact on tissue health and bone integration around dental implants. This study is sponsored by Koite Health Oy and compares Lumoral with standard treatments.

Who may be eligible for this peri-implantitis clinical trial?

Adults aged 18 to 85 with dental implants showing specific signs of peri-implantitis may be eligible. Participants should be able to follow the treatment protocol and avoid other oral hygiene methods outside the study. People who are pregnant, actively smoke, or have certain systemic diseases may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this peri-implantitis clinical trial?

Study-related care, including the study device, treatments, and all trial visits, is provided at no cost. However, personal travel expenses to and from visits may not be covered and can vary. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 85Years

All Genders

ID06017817

Evaluating Regular Home Use of Antibacterial Photodynamic Therapy with Lumoral for Treating Peri-implantitis

Led by Koite Health Oy · Updated on 2026-08-07

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the Lumoral method, a home-use antibacterial photodynamic therapy, for managing peri-implantitis, a condition characterized by inflammation around dental implants including bleeding, suppuration, increased probing depth, and bone loss. This study aims to determine the effectiveness of this method in improving plaque control and reducing inflammation, potentially enhancing tissue health and osseointegration. The trial involves both non-surgical and surgical treatment approaches combined with standard oral hygiene instructions. Participants are assigned to one of four groups two non-surgical groups where one receives the Lumoral treatment alongside scaling and root planing plus oral hygiene instructions, and the other receives only the standard non-surgical treatment and oral hygiene guidance and two surgical groups where one receives the Lumoral treatment with surgical anti-infective peri-implantitis treatment and oral hygiene instructions, while the other receives surgical treatment plus oral hygiene instructions without Lumoral. The Lumoral method involves swishing a photoactive mouth rinse that binds to dental plaque and activating it with a light applicator at home. During the study, participants will be monitored over six months with assessments including bleeding on probing, active MMP-8 levels, various inflammatory markers, periodontal pocket depth, plaque index, clinical attachment level, bacterial flora, and patient-reported outcomes through questionnaires. Adverse events will be tracked to ensure safety. Participants will follow the assigned treatment protocols and standard oral hygiene routines, with regular evaluations to measure treatment effects and tissue health.

CONDITIONS

Brief Title

Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

Who Can Participate

Age: 18Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Probing pocket depth (PPD) of 6 mm or more and marginal bone loss greater than 3 mm
Dental implants must be collected and clinically characterized according to Lähteenmäki et al. CEDR-22
Agreement to participate and sign a written consent form
Ability to cooperate with the treatment protocol and avoid other oral hygiene measures outside the study protocol

You will not qualify if you...

Any physical limitation that restricts use of the Lumoral device
Unwillingness to participate in the study
Pregnancy or lactation
Active smoking
Medicated diabetes mellitus
Any systemic disease that can affect peri-implantitis progression
Use of antibiotics, doxycycline, chlorhexidine, or bisphosphonates within 4 weeks before participation
Peri-implant or periodontal treatment within 3 months before participation
Having a removable major prosthesis or major orthodontic appliance

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 months

Participants receive assigned treatments, which may include Lumoral antibacterial photodynamic therapy combined with non-surgical or surgical anti-infective procedures, alongside standard oral hygiene instructions.