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

Not Applicable

Not yet recruiting

• Conditions: Peri-implant Mucositis

• Registration Number: NCT06859866
• Lead Sponsor: Koite Health Oy

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.

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Study First Posted: 2025-03-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Study Start: 2025-06
• Primary Completion: 2026-10
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bleeding on probing (BOP)	6 months	Change in the inflammatory parameter BOP.A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual). Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus. Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent". BOP is reported as the percentage (%) of sites with positive findings.; Calculation formula: number of bleeding sites/ 6 times number of teeth.

Secondary Outcome Measures

Name	Time	Method
Visual Plaque Index (VPI)	6 months	Assessment of six index teeth, measured at four sites per tooth; Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent" VPI reported as the percentage (%) of sites with plaque Calculation formula: number of sites with plaque/ 4 times number of teeth
Peridontal Pocket Depth (PPD)	6 months	A full-mouth assessment, measured at six sites per tooth. Assessed from the base of the pocket to the gingival margin (mm)
KIPM (Keratinized Implant Peri-implant Mucosa Width)	6 months	KMW is calculated at the midfacial as the distance in millimeters from the free mucosal margin to the mucogingival junction and classified as adequate (≥2 mm) or inadequate (\<2 mm)
Biomolecular Analysis	6 months	The concentration of active Metalloproteinase-8 (aMMP-8) in peri-implant sulcular fluid (PISF) will be assessed with an ELISA test.

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,; 🇮🇹 Roma, Italy