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.
Adults aged 18 years or older who agree to participate and provide written informed consent.
Rehabilitated with a screw-retained full-arch implant-supported fixed prosthesis (All-on-4, All-on-6 or All-on-X) delivered at least 3 months before enrolment.
Diagnosed with peri-implant mucositis according to the 2017 World Workshop case definitions.
HbA1c below 7.0% and stable systemic health.
Disability or severe motor impairment limiting the ability to perform the oral hygiene procedures required by the study.
Long-term antibiotic therapy.
Immunodeficiency.
Long-term corticosteroid therapy.
Parallel
Dual-light antibacterial photodynamic therapy
DeviceAn 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.
Supportive peri-implant care
Procedure/SurgeryStandardized 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.
Change in mean bleeding on probing (BOP) index
The number of bleeding sites is recorded 30 seconds after probing at six sites per implant using a UNC-15 periodontal probe with a standardized probing force of 0.25 N, summed across all implants, and divided by the number of implants to yield a patient-level mean BOP index (range 0-6). The outcome is the change from baseline to week 4; negative values indicate improvement.
Change in subgingival load of Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum
Quantified by real-time PCR from paper-point samples collected at the same predefined implant and site at each timepoint, expressed as log10 gene copies per sample. Reported as the change from baseline.
Change in mean peri-implant probing depth (PID)
Peri-implant probing depth is measured at six sites per implant with a UNC-15 periodontal probe under a standardized probing force of 0.25 N. The deepest of the six sites is recorded for each implant, and the patient-level mean is calculated by dividing the sum of implant values by the number of implants. Reported in milli-metres as the change from baseline.
Adherence to the home-use intervention
Number of days on which the prescribed home protocol was completed, recorded in a daily patient diary and corroborated by photosensitizer usage counts and structured questioning at each follow-up visit. Applicable to the intervention arm.
Incidence of adverse events
Number and nature of adverse events reported by participants or observed clinically, including local discomfort, mucosal irritation, or transient warmth associated with device use.
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