Actively Recruiting
Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis
Led by Koite Health Oy · Updated on 2025-08-05
30
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
K
Koite Health Oy
Lead Sponsor
U
University of Roma La Sapienza
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of at least 20 teeth within the oral cavity
- Diagnosis of peri-implant mucositis with bleeding or suppuration upon gentle probing, with or without increased probing depth, and no bone loss beyond initial remodeling
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Pregnancy
- History of periodontitis
- Use of medications affecting soft tissues in the past 6 months, including antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers
- Allergy to the photosensitizer
- Presence of removable major prostheses or orthodontic appliances
- Untreated carious lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,
Roma, Italy, 00161
Actively Recruiting
Research Team
M
Mikko Kylmänen, Master of Health Care
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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