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

RecruitingNAAges 18 Years - anyAllKoite Health Oy
NCT06859866 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Standard oral hygiene
  • The addition of home-based dual-light photodynamic therapy (Lumorinse® + Lumoral®)
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Where

1 site
Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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