[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605723":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":11,"centralContacts":11,"locations":31,"responsibleParty":67,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Blekinge Institute of Technology","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Partisipants with Lumoral Dual-Light aPDT + Manual Toothbrush","EXPERIMENTAL",null,[13],"Device: Dual-Light aPDT Treatment - Lumoral",{"label":15,"type":10,"description":11,"interventionNames":16},"Partisipants with Oral-B iO Powered Toothbrush",[17],"Device: Oral-B Powered toothbrush",{"label":19,"type":20,"description":11,"interventionNames":11},"Control Group","NO_INTERVENTION",[22,27],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DEVICE","Oral-B Powered toothbrush","Intervention Group B:\n\nParticipants receive standardized oral hygiene instructions and use an Oral-B iO powered toothbrush during the test period.\n\nThe Oral-B iO is an advanced powered toothbrush that combines oscillating-rotating and micro-vibrating bristle movements with real-time feedback technology. It is CE-marked for home use and designed to improve plaque removal and overall oral hygiene compared to manual toothbrushing. The device incorporates pressure sensors and guided brushing modes to support optimal brushing technique and patient adherence, which may contribute to improved periodontal outcomes.",[15],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Dual-Light aPDT Treatment - Lumoral","Intervention Group A:\n\nParticipants receive standardized oral hygiene instructions and use only a manual toothbrush during the test period, with the addition of an adjunctive antimicrobial photodynamic therapy (aPDT) device (Lumoral®).\n\nThe Lumoral® treatment device is a CE-marked antibacterial device intended for home use. It is designed to support the treatment and prevention of oral diseases caused by bacterial biofilms. The device functions by emitting light at a specific wavelength, which activates a CE-marked photosensitizing mouthrinse, Lumorinse®. This light-activated process enhances antibacterial efficacy, targeting pathogenic microorganisms in the oral cavity and supporting improved oral hygiene outcomes.",[9],[32],{"facility":33,"status":11,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Blekinge Tekniska Högskola","Karlskrona","Blekinge County","371 79","Sweden","SE",{"type":40,"coordinates":41},"Point",[42,43],15.58661,56.16156,{"lat":43,"lon":42},[46,51,55,58,61,63,65],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Johan Sanmartin Berglund Professor","CONTACT","+46 (0) 455-385471","johan.sanmartin.berglund@bth.se",{"name":52,"role":48,"phone":53,"phoneExt":11,"email":54},"Evelina Klingborg PhD student","+46 732407575","evelina.klingborg@bth.se",{"name":56,"role":57,"phone":11,"phoneExt":11,"email":11},"Johan Flyborg, DDS PhD","PRINCIPAL_INVESTIGATOR",{"name":59,"role":60,"phone":11,"phoneExt":11,"email":11},"Stefan Renvert, Professor","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":11,"phoneExt":11,"email":11},"Seida Erovic Ademovski, PhD",{"name":64,"role":60,"phone":11,"phoneExt":11,"email":11},"Evelina Klingborg, PhD student",{"name":66,"role":60,"phone":11,"phoneExt":11,"email":11},"Johan Sanmartin Berglund, Professor",{"type":68,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100605723","the-effect-of-regular-home-use-of-dual-light-antibacterial-photodynamic-therapy-apdt-or-the-use-of-a-powered-toothbrush-in-older-individuals-with-periodontitis-and-mild-cognitive-impairment-100605723",false,"NCT07166224","The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment.","The Effect of Regular Home Use of Dual-light Antibacterial Photodynamic Therapy (aPDT) or the Use of a Powered Toothbrush in Older Individuals With Periodontitis and Mild Cognitive Impairment: a Randomized Controlled Trial.","e-DENT II","Inclusion Criteria:\n\n* Adults aged ≥60 years\n* ≥15 teeth\n* Diagnosed periodontitis stage I-III\n* MMSE score between 22-28\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Antibiotic use (within 3 months)\n* Lumoral use within 3 months\n* Bisphosphonate medication\n* Immunosuppressive drugs or radiation therapy","ALL","60 Years",{"count":80,"type":81},90,"ESTIMATED","INTERVENTIONAL",[84],"NA","Objective:\n\nTo compare three different oral hygiene regimens regarding plaque index (PI), bleeding on probing (BOP), the number of deepened periodontal pockets ≥4 mm (PPD), oral halitosis, and changes in oral health-related quality of life (OHRQoL) in an older population with periodontitis stage I-III and mild cognitive impairment.\n\n1. Are there improvements in plaque index (PI), number of bleeding on probing (BOP) sites, number of probing depths (PPD), and intraoral halitosis in the two test groups compared to the control group?\n2. Do the study interventions affect oral health-related quality of life in older adults with periodontitis and mild cognitive impairment?\n\nStudy design:\n\nType: Randomized controlled trial Duration: 6 months per participant, 2 years in total for data collection Participants: 90 participants divided into Intervention and Control groups\n\nIntervention Group A (Lumoral Dual-Light aPDT + Manual Toothbrush) Standardized oral hygiene instructions and the use of a manual toothbrush during the test period, with an adjunctive aPDT device (Lumoral®).\n\nIntervention Group B (Oral-B iO Powered Toothbrush) Standardized oral hygiene instructions and the use of an Oral-B iO powered toothbrush during the test period.\n\nControl Group Standardized oral hygiene instructions and the use of a manual TePe Select extra soft toothbrush during the test period.",[87,88],"Periodontal Diseases","Oral Halitosis",[90,91,92,93],"Mild Cognitive Impairment","Oral health","Quality of life","Powered toothbrush","NOT_YET_RECRUITING","2025-09-16",{"date":97,"type":98},"2025-09-19","ACTUAL",{"date":100,"type":81},"2025-10",{"date":102,"type":81},"2028-12",{"name":5,"class":6},1]