NCT06017817 Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
| NCT ID | NCT06017817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nilminie Rathnayake |
| Condition | Peri-Implantitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-05-13 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.
Eligibility 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
Contact & Investigator
Nilminie Rathnayake, Assoc Prof
PRINCIPAL INVESTIGATOR
University of Helsinki
Frequently Asked Questions
Who can join the NCT06017817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Peri-Implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06017817 currently recruiting?
Yes, NCT06017817 is actively recruiting participants. Contact the research team at mikko.kylmanen@koitehealth.com for enrollment information.
Where is the NCT06017817 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06017817 clinical trial?
NCT06017817 is sponsored by Nilminie Rathnayake. The principal investigator is Nilminie Rathnayake, Assoc Prof at University of Helsinki. The trial plans to enroll 80 participants.