Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis
Recruiting now · Not applicable
Conditions studied: Peri-implant Mucositis
In brief
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).
Key facts
- Study ID
- NCT06859866
- Run by
- Koite Health Oy
- People needed
- 30
- Starts
- 2025-04-29
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2025-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma, — Roma, Italy (enrolling)
Full record on ClinicalTrials.gov
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