Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06859866

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

Led by Koite Health Oy · Updated on 2025-08-05

30

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

K

Koite Health Oy

Lead Sponsor

U

University of Roma La Sapienza

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new at-home photodynamic and antibacterial blue light therapy combined with non-surgical professional treatment to manage peri-implant mucositis, an inflammation of the tissue around dental implants without bone loss. This condition affects a large portion of dental implants and can lead to implant failure if untreated. The study will measure improvements in plaque, bleeding, pocket depth, and inflammation markers in the gum fluid to assess treatment effects. Participants will be randomly assigned to one of two groups: one receiving standard oral hygiene care including professional cleaning, oral hygiene instructions, and antiseptic gel, and the other group using a home-based dual-light photodynamic therapy device alongside regular oral hygiene. The device uses a mouthguard-shaped LED light to activate a photosensitizer in a mouth rinse, producing antibacterial effects. Treatments and evaluations will take place over 6 and 12 months. During the study, participants will undergo clinical assessments such as bleeding on probing, plaque scoring, pocket depth measurements, and biomolecular analysis of gum fluid. Changes in the width of keratinized gum tissue and patient-reported outcomes will also be monitored. Follow-up visits will reinforce oral hygiene and track safety and effectiveness over the study period, which lasts up to 12 months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 12 months

Participants receive standard oral hygiene care and may also use a home-based antibacterial medical device involving photodynamic therapy to treat peri-implant mucositis.

Regular follow-up visits for assessment during treatment

Trial Site Locations

Total: 1 location

1

Department of Oral and Maxillofacial Sciences, Sapienza Università di Roma,

Roma, Italy, 00161

Actively Recruiting

Loading map...

Research Team

M

Mikko Kylmänen, Master of Health Care

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

AI-Based Colorimetric System for Objective Diagnosis of Peri...

Peri-implant Mucositis

Actively Recruiting

1 location

Antiseptic Effects on the Dental Implant Internal Surface Mi...

Peri-Implantitis

Actively Recruiting

1 location

Distance Between Dental Implants as a Risk Indicator for Per...

Peri-implant Mucositis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus.

Sakari Nikinmaa, Anna Podonyi, Peter Raivio...

https://pubmed.ncbi.nlm.nih.gov/34680821

Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation.

Sakari Nikinmaa, Heikki Alapulli, Petri Auvinen...

https://pubmed.ncbi.nlm.nih.gov/32374766

Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study.

Hanna Lähteenmäki, Tommi Pätilä, Ismo T Räisänen...

https://pubmed.ncbi.nlm.nih.gov/35723308

Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors.

N J Kassebaum, A G C Smith, E Bernabé...

https://pubmed.ncbi.nlm.nih.gov/28792274