Using antibacterial photodynamic therapy to treat peri-implantitis
Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
This study is testing a new light-activated mouth rinse to see if it can help people with peri-implantitis manage their gum inflammation and plaque better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Koite Health Oy Industry-sponsored |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06017817 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Lumoral method, which utilizes antibacterial photodynamic therapy (aPDT) to manage peri-implantitis. The approach involves using a photoactive mouth rinse that adheres to dental plaque and is activated by a light applicator, aiming to improve plaque control and reduce inflammation. Participants will receive standard oral hygiene instructions alongside the Lumoral treatment, and their progress will be monitored through clinical assessments of inflammation and plaque levels. The study seeks to determine if this innovative method can enhance long-term outcomes for patients with peri-implantitis.
Who should consider this trial
Good fit: Ideal candidates are individuals with probing pocket depth of 6 mm or greater and marginal bone loss exceeding 3 mm around dental implants.
Not a fit: Patients with systemic diseases affecting wound healing, active smokers, or those who have undergone recent periodontal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less invasive option for managing peri-implantitis, improving oral health and implant longevity.
How similar studies have performed: Preliminary results from similar approaches using antibacterial photodynamic therapy have shown promising outcomes, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm
- Södertandläkarna AB — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Nilminie Rathnayake, Assoc Prof — University of Helsinki
- Study coordinator: Mikko Kylmänen
- Email: mikko.kylmanen@koitehealth.com
- Phone: +358407245934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.