About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard oral hygiene
- The addition of home-based dual-light photodynamic therapy (Lumorinse® + Lumoral®)
Treatment groups
Sponsors and collaborators
Koite Health Oy
Lead sponsor
University of Roma La Sapienza
Collaborator