Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Efficacy of Home-Use Dual-Light Antimicrobial Photodynamic Therapy as an Adjunct to Supportive Peri-Implant Care in Patients With Peri-Implant Mucositis Around Screw-Retained Full-Arch Implant-Supported Prostheses: A Pilot Randomized Controlled Trial
1 other identifier
interventional
24
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2026
CompletedFirst Posted
Study publicly available on registry
August 13, 2026
CompletedStudy Start
First participant enrolled
September 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 10, 2027
August 13, 2026
August 1, 2026
6 months
August 10, 2026
August 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Baseline, 2 weeks and 4 weeks
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.
Baseline, 2 weeks and 4 weeks
Secondary Outcomes (3)
Change in mean peri-implant probing depth (PID)
Baseline, 2 weeks and 4 weeks
Adherence to the home-use intervention
4 weeks
Incidence of adverse events
4 weeks
Study Arms (2)
Supportive peri-implant care plus dual-light aPDT
EXPERIMENTALParticipants receive standardized supportive peri-implant care and additionally use a home-based dual-light antibacterial photodynamic therapy device daily for 4 weeks: once daily during weeks 1-2 and twice daily during weeks 3-4. Each 10-minute session delivers 405 nm antibacterial blue light and 810 nm near-infrared light simultaneously at 30 J/cm2, with an indocyanine green photosensitizer mouth rinse (250 µg/mL).
Supportive peri-implant care alone
ACTIVE COMPARATORParticipants receive standardized supportive peri-implant care only, comprising risk factor assessment and counselling, individualized oral hygiene instruction for a full-arch fixed implant-supported prosthesis, and professional mechanical plaque removal with implant-safe plastic ultrasonic tips, without any adjunctive light-based therapy.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Non-smoker for at least the preceding 6 months.
- Willing to attend all scheduled follow-up visits at 2 and 4 weeks and to comply with the home-use protocol.
You may not qualify if:
- 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.
- History of organ transplantation.
- Refusal to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PMID: 27777223RESULTPakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
PMID: 36354651RESULTPakarinen S, Valimaa H, Heikkinen AM, Noponen M, Alapulli H, Saarela RKT, Tervahartiala T, Raisanen IT, Sorsa T, Sakellari D, Patila T. A randomized controlled trial of home-applied dual-light photodynamic therapy during supportive periodontal care (HOPE-CP study). J Periodontol. 2026 Apr;97(4):720-731. doi: 10.1002/jper.70082. Epub 2026 Mar 6.
PMID: 41789792RESULTHerrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4.
PMID: 37271498RESULT
Study Officials
- STUDY DIRECTOR
Thuy Thu Nguyen, DDS, PhD, Assoc. Prof.
University of Medicine and Pharmacy at Ho Chi Minh City
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Student, Department of Periodontology, Faculty of Dentistry
Study Record Dates
First Submitted
August 10, 2026
First Posted
August 13, 2026
Study Start
September 10, 2026
Primary Completion (Estimated)
March 10, 2027
Study Completion (Estimated)
July 10, 2027
Last Updated
August 13, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared publicly. De-identified data may be made available from the corresponding author on reasonable request, subject to approval by the institutional ethics committee.