Adjunctive at-home photodynamic (blue-light) therapy for peri-implant mucositis

Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis: A Post-Marketing Interventional Pilot Study With a Medical Device

This test tries whether adding an at-home antibacterial blue-light photodynamic device to regular non-surgical care helps people with peri-implant mucositis reduce plaque, bleeding, pocket depth, and aMMP-8 inflammation markers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Koite Health Oy (industry)
• Locations: 1 site (Roma)
• Trial ID: NCT06859866 on ClinicalTrials.gov

What this trial studies

The study combines standard non-surgical professional cleaning with a novel at-home dual-light photodynamic/antibacterial system (Lumorinse + Lumoral) for patients diagnosed with peri-implant mucositis. Participants will use the at-home device between clinic visits while investigators record clinical measures like plaque and bleeding scores, probing pocket depths, and aMMP-8 levels from peri-implant sulcular fluid. Secondary outcomes include changes in keratinized peri-implant mucosa and patient-reported outcome measures. The trial takes place at Sapienza University of Rome and integrates clinical exams with biomarker testing to validate an at-home biofilm-control protocol.

Who should consider this trial

Good fit: Ideal candidates are adults with a clinical diagnosis of peri-implant mucositis, at least 20 teeth, able to give informed consent, and without a history of periodontitis or recent medications that affect soft tissues.

Not a fit: Patients with peri-implantitis (bone loss), a history of periodontitis, allergies to the photosensitizer, removable major prostheses, untreated caries, pregnancy, or recent use of interfering medications are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could allow people to better control peri-implant biofilm at home, lowering inflammation and the risk of progression to more severe implant disease.

How similar studies have performed: Professional photodynamic therapies have shown promising antibacterial and anti-inflammatory effects in some studies, but home-based dual-light aPDT protocols are relatively new and lack extensive long-term randomized evidence.

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.

Where this trial is running

Roma

• Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma, — Roma, Italy (RECRUITING)

Study contacts

• Principal investigator: Alberto De Biase, Professor — Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,
• Study coordinator: Mikko Kylmänen, Master of Health Care

Conditions: Peri-implant Mucositis, APDT, aMMP-8, antibacterial