Clinical Trial

Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis

Recruiting
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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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-02-28; most recent amendment 2025-08-04.
Status change: Not Yet Recruiting → Recruiting 2025-06-18
Trial Details
NCT Number NCT06859866
Lead Sponsor Koite Health Oy
Collaborators: University of Roma La Sapienza
Conditions Peri-implant Mucositis
Enrollment 30 participants
Start Date 2025-04-29
Primary Completion 2026-10 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-05