Clinical trial NCT06859866: Efficacy of Adjunctive At-Home Photodynamic Therapy (aPDT) in the Treatment of Peri-Implant Mucositis
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: APDT
aMMP-8
antibacterial
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Roma La Sapienza
First posted: 2025-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either the non-surgical treatment (TNC) group or the non-surgical treatment + Lumoral® (TNCL group) using sealed envelopes, with an equal number of envelopes for each treatment group. Each group will consist of 15 patients.
Primary purpose: TREATMENT

Brief 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).

Detailed description: Dental implants offer an opportunity to restore oral health by replacing missing teeth, demonstrating exceptional longevity when properly maintained. The maintenance of implant health primarily depends on the effective removal of dental plaque, which is the primary cause of periodontal diseases, from both dental and prosthetic surfaces.

According to an accepted definition, peri-implant mucositis is an inflammation of the peri-implant mucosa without loss of supporting bone tissue, while peri-implantitis is characterized by inflammation of the peri-implant mucosa associated with supporting bone loss. Recent data indicate that a significant proportion, ranging from 50% to 90%, of implants are affected by peri-implant mucositis.

The diagnosis of peri-implant mucositis is currently based on clinical observations; however, clinical evaluations may yield false positives or fail to allow early diagnosis and timely treatment of pathological conditions. With the knowledge of the current restrictions, this study aims to evaluate the levels of active matrix metalloproteinase-8 (aMMP-8) derived from Peri-Implant Sulcular Fluid (PISF), which is one of the most precise and sensitive diagnostic markers of peri-implant tissue inflammation.

The treatment of peri-implant mucositis currently encompasses a range of professional and at-home measures. Typically, peri-implant mucositis precedes the characteristic bone loss of peri-implantitis; therefore, the timely treatment of clinical signs of inflammation is critical to prevent disease progression that could culminate in implant failure. Inadequate plaque removal increases the risk of peri-implantitis by hindering access to implant sites for oral hygiene, resulting in a higher incidence in areas that patients are unable to clean effectively compared to easily accessible sites, underscoring the importance of focusing on at-home dental care.

New methods for at-home oral care are under development, such as antimicrobial photodynamic therapy (aPDT), which utilizes a photosensitizer (PS) and low-intensity visible light to generate reactive oxygen species (ROS) that target pathogenic bacteria. Antibacterial blue light takes advantage of the intrinsic antimicrobial properties derived from endogenous photosensitizing chromophores of pathogenic microbes, eliminating the need for exogenous dyes.

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.

Primary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: 12 months
measure: Bleeding on probing (BOP)
timeFrame: 6 months
Secondary outcomes:
measure: Visual Plaque Index (VPI)
timeFrame: 12 months
measure: Visual Plaque Index (VPI)
timeFrame: 6 months
measure: Peridontal Pocket Depth (PPD)
timeFrame: 12 months
measure: Peridontal Pocket Depth (PPD)
timeFrame: 6 months
measure: KIPM (Keratinized Implant Peri-implant Mucosa Width)
timeFrame: 12 months
measure: KIPM (Keratinized Implant Peri-implant Mucosa Width)
timeFrame: 6 months
measure: Biomolecular Analysis
timeFrame: 12 months
measure: Biomolecular Analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,
Study officials:
affiliation: Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,
name: Alberto De Biase, Professor
role: PRINCIPAL_INVESTIGATOR
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