NCT Number: NCT07763431
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Peri-implant mucositis is a frequent biological complication in patients rehabilitated with dental implants, primarily resulting from bacterial biofilm accumulation and the subsequent inflammatory response of the peri-implant soft tissue. It is regarded as the reversible precursor of peri-implantitis and, if left uncontrolled, may progress to irreversible bone loss around the implant. In patients rehabilitated with screw-retained full-arch implant-supported prostheses (All-on-4, All-on-6, or All-on-X), the fixed prosthesis cannot be removed by the patient and its design limits access to the peri-implant tissues, making effective home plaque control particularly difficult.
Supportive peri-implant care remains the mainstay of management; however, its effectiveness depends heavily on the patient's ability to maintain plaque control between professional maintenance visits. Adjunctive, non-antibiotic measures that can be applied daily at home are therefore of interest. Dual-light antibacterial photodynamic therapy, which combines antimicrobial photodynamic therapy with antibacterial blue light, provides a repeatable bactericidal effect without inducing antimicrobial resistance and has recently become available in a commercial home-use device.
This study is designed as a two-arm, parallel-group, single-blind pilot randomized controlled trial to evaluate the clinical and microbiological effects of adjunctive home-use dual-light antibacterial photodynamic therapy in patients with peri-implant mucositis around screw-retained full-arch implant-supported prostheses. Eligible participants will be recruited from the High-Tech Departments 1 and 2 of the Ho Chi Minh City Hospital of Odonto-Stomatology. All participants will receive standardized supportive peri-implant care and will then be randomly assigned in a 1:1 ratio to one of two groups: an intervention group that additionally performs home-use dual-light therapy daily for four weeks, or a control group that receives supportive peri-implant care alone. Randomization will use a software-generated block sequence prepared by an independent person, with allocation concealed by sequentially numbered, opaque, sealed envelopes.
Clinical parameters including bleeding on probing and peri-implant probing depth will be recorded at baseline, at two weeks, and at four weeks. Subgingival samples will be collected and analyzed by real-time polymerase chain reaction (qPCR) to quantify the levels of four periodontal pathogenic bacteria: Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, and Fusobacterium nucleatum. Adherence to the home-use protocol will be monitored using a daily patient diary, and structured questioning at each follow-up visit.
Clinical measurements and microbiological sampling will be performed by a single calibrated examiner who is blinded to group allocation, in order to minimize measurement bias, and standardized oral hygiene instructions will be provided to all participants throughout the study period. As this is the first study of dual-light antibacterial photodynamic therapy in this population, no reliable prior data are available for an a priori power calculation; the study is therefore conducted as a pilot trial in line with the CONSORT 2010 extension for pilot and feasibility trials. The collected data will be analyzed to determine differences in peri-implant inflammation, probing depth, and subgingival bacterial load between the two treatment modalities. The findings are expected to provide preliminary, evidence-based insights into the potential benefit of home-use dual-light antibacterial photodynamic therapy as an adjunct to supportive peri-implant care, and to inform the design of a future definitive trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 2 weeks and 4 weeks
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.
Time frame: Baseline, 2 weeks and 4 weeks
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.
Time frame: Baseline, 2 weeks and 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Number and nature of adverse events reported by participants or observed clinically, including local discomfort, mucosal irritation, or transient warmth associated with device use.
Contact information is provided by the study sponsor or research team.
University of Medicine and Pharmacy at Ho Chi Minh City
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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