NCT06859866 Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis
| NCT ID | NCT06859866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Koite Health Oy |
| Condition | Peri-implant Mucositis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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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 30 participants in total. It began in 2025-04-29 with a primary completion date of 2026-10.
⚠ 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
The study aims to establish a validated protocol enabling an alternative approach for bacterial biofilm control through the application of a novel at-home photodynamic/antibacterial blue light therapy in addition to non-surgical professional treatment (NST) for peri-implant mucositis. The primary outcomes will include reductions in plaque and bleeding scores, decreases in probing pocket depth, and lower aMMP-8 levels in PISF. Secondary outcomes will include changes in keratinized peri-implant mucosa (KPIM) and patient-reported outcome measures (PROMs).
Eligibility Criteria
Inclusion Criteria: * Presence of at least 20 teeth within the oral cavity. * Diagnosis of peri-implant mucositis: bleeding or suppuration upon gentle probing with or without increased probing depth compared to previous evaluations, and no bone loss beyond the changes in the crestal bone level resulting from initial bone remodeling. * Patients willing and able to provide written informed consent. Exclusion Criteria: * Pregnancy. * Patients with a history of periodontitis. * Use of medications that could affect soft tissues within the past 6 months (e.g., antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline and bisphosphonates). * Allergy to the photosensitizer. * Patients with removable major prostheses or orthodontic appliances. * Patients with untreated carious lesions.
Contact & Investigator
Alberto De Biase, Professor
PRINCIPAL INVESTIGATOR
Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,
Frequently Asked Questions
Who can join the NCT06859866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peri-implant Mucositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06859866 currently recruiting?
Yes, NCT06859866 is actively recruiting participants. Contact the research team at mikko.kylmanen@koitehealth.com for enrollment information.
Where is the NCT06859866 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06859866 clinical trial?
NCT06859866 is sponsored by Koite Health Oy. The principal investigator is Alberto De Biase, Professor at Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,. The trial plans to enroll 30 participants.