Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses

Summary

The goal of this clinical trial is to learn whether a home-use light device helps control gum inflammation around dental implants in adults who have a full set of fixed teeth attached to implants. This gum inflammation, called peri-implant mucositis, is common and reversible, but can lead to more serious problems if it is not controlled. The device is meant to be added to the usual professional cleaning and hygiene care, not to replace it.

The main questions it aims to answer are:

* Does adding the home-use light device reduce gum bleeding around the implants more than the usual care alone?
* Does it reduce the depth of the space around the implants and the amount of harmful bacteria?

Researchers will compare adults who receive the usual professional care plus the home-use light device with adults who receive the usual professional care alone, to see if the device improves gum health.

Participants will:

* Receive professional cleaning and personalized instructions on how to keep their implant teeth clean at the start of the study.
* Be placed by chance into one of two groups: usual care plus the home-use light device, or usual care alone.
* Use the light device at home each day for 4 weeks (if in the device group)
* Visit the clinic at the start, after 2 weeks, and after 4 weeks for gum checkups and to have bacteria samples taken.

Conditions

• Peri Implant Mucositis
• Dental Implant Rehabilitation
• Prosthesis and Implant Dentistry
• Implant Supported Prosthesis
• Photodynamic Therapy (PDT)
• Antimicrobial Photodynamic Therapy

Interventions

DEVICE

Dual-light antibacterial photodynamic therapy

An intraoral light-emitting device with 48 LEDs delivering 405 nm antibacterial blue light and 810 nm near-infrared light simultaneously in a 50:50 ratio, providing uniform illumination of both arches. Used with an indocyanine green photosensitizer rinse (250 µg/mL). Each session lasts 10 minutes at 30 J/cm2. Self-administered at home: once daily in weeks 1-2, twice daily in weeks 3-4.

PROCEDURE

Supportive peri-implant care

Standardized supportive peri-implant care delivered according to the 2023 EFP S3-level clinical practice guideline for the prevention and treatment of peri-implant diseases, following an etiology-based, non-surgical approach: (1) assessment and control of risk factors, including smoking, glycemic control, and oral hygiene, with counselling; (2) evaluation of the fixed prosthesis and, where the design impairs access, removal of the screw-retained prosthesis to allow direct access to the implant necks and peri-implant soft tissue; (3) individualized oral hygiene instruction adapted to a full-arch fixed implant-supported prosthesis; (4) professional mechanical plaque removal above and below the mucosal margin using implant-safe plastic ultrasonic tips, without altering the implant surface; and (5) reassessment and reinforcement of oral hygiene at follow-up. No adjunctive antibiotics or antiseptics are used as part of the standard care.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City

  lead OTHER

Principal Investigators

• Thuy Thu Nguyen, DDS, PhD, Assoc. Prof. · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-10

Primary Completion

2027-03-10

Completion

2027-07-10