Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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).

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

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 details
    Peri-implant Mucositis

NCT06859866

Koite Health Oy

15 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.