[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651563":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":26,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":26,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":26,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"University of Medicine and Pharmacy at Ho Chi Minh City","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive peri-implant care plus dual-light aPDT","EXPERIMENTAL","Participants 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\u002Fcm2, with an indocyanine green photosensitizer mouth rinse (250 µg\u002FmL).",[13,14],"Device: Dual-light antibacterial photodynamic therapy","Procedure: Supportive peri-implant care",{"label":16,"type":17,"description":18,"interventionNames":19},"Supportive peri-implant care alone","ACTIVE_COMPARATOR","Participants 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.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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\u002FmL). Each session lasts 10 minutes at 30 J\u002Fcm2. Self-administered at home: once daily in weeks 1-2, twice daily in weeks 3-4.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"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.",[16,9],[33],{"name":34,"affiliation":5,"role":35},"Thuy Thu Nguyen, DDS, PhD, Assoc. Prof.","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Huy Cong Ho, Doctor of Dental Surgery (DDS)","CONTACT","84 + 827555408","conghuy.ho.9@gmail.com",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Hồ Công Huy","Master's Student, Department of Periodontology, Faculty of Dentistry","100651563","home-use-dual-light-antibacterial-photodynamic-therapy-for-peri-implant-mucositis-in-full-arch-implant-prostheses-100651563",false,"NCT07763431","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","Inclusion Criteria:\n\n* Adults aged 18 years or older who agree to participate and provide written informed consent.\n* 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.\n* Diagnosed with peri-implant mucositis according to the 2017 World Workshop case definitions.\n* HbA1c below 7.0% and stable systemic health.\n* Non-smoker for at least the preceding 6 months.\n* Willing to attend all scheduled follow-up visits at 2 and 4 weeks and to comply with the home-use protocol.\n\nExclusion Criteria:\n\n* Disability or severe motor impairment limiting the ability to perform the oral hygiene procedures required by the study.\n* Long-term antibiotic therapy.\n* Immunodeficiency.\n* Long-term corticosteroid therapy.\n* History of organ transplantation.\n* Refusal to participate.","ALL","18 Years",{"count":56,"type":57},24,"ESTIMATED","INTERVENTIONAL",[60],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Does adding the home-use light device reduce gum bleeding around the implants more than the usual care alone?\n* Does it reduce the depth of the space around the implants and the amount of harmful bacteria?\n\nResearchers 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.\n\nParticipants will:\n\n* Receive professional cleaning and personalized instructions on how to keep their implant teeth clean at the start of the study.\n* Be placed by chance into one of two groups: usual care plus the home-use light device, or usual care alone.\n* Use the light device at home each day for 4 weeks (if in the device group)\n* Visit the clinic at the start, after 2 weeks, and after 4 weeks for gum checkups and to have bacteria samples taken.",[63,64,65,66,67,68],"Peri Implant Mucositis","Dental Implant Rehabilitation","Prosthesis and Implant Dentistry","Implant Supported Prosthesis","Photodynamic Therapy (PDT)","Antimicrobial Photodynamic Therapy","NOT_YET_RECRUITING","2026-08-10",{"date":72,"type":73},"2026-08-13","ACTUAL",{"date":75,"type":57},"2026-09-10",{"date":77,"type":57},"2027-07-10",{"name":5,"class":6}]