[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517459":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":60,"responsibleParty":77,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":36,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":36,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":63,"whyStopped":36,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Koite Health Oy","INDUSTRY",[8,16,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-surgical treatment, Study group (NST-1)","EXPERIMENTAL","Lumoral Treatment; Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.",[13,14,15],"Device: Lumoral Treatment","Procedure: Standard oral hygiene instructions","Procedure: Scaling and root planing (SRP",{"label":17,"type":18,"description":19,"interventionNames":20},"Non-surgical treatment, Control group (NST-2)","ACTIVE_COMPARATOR","Standard, non-surgical anti-infective treatment by scaling and root planing (SRP); and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.",[14,15],{"label":22,"type":10,"description":23,"interventionNames":24},"Surgical treatment, Study group (ST-1)","Lumoral Treatment; Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.",[13,14,25],"Procedure: surgical anti-infective peri-implantitis treatment",{"label":27,"type":18,"description":28,"interventionNames":29},"Surgical treatment, Control group (ST-2)","Surgical anti-infective peri-implantitis treatment; and Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use.",[14,25],[31,37,42,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Lumoral Treatment","Anti-infective photodynamic therapy for plaque-induced oral conditions",[9,22],null,{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":36},"PROCEDURE","Standard oral hygiene instructions","Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use",[17,9,27,22],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"Scaling and root planing (SRP","non-surgical anti-infective treatment by scaling and root planing",[17,9],{"type":38,"name":47,"description":47,"armGroupLabels":48,"otherNames":36},"surgical anti-infective peri-implantitis treatment",[27,22],[50],{"name":51,"affiliation":52,"role":53},"Nilminie Rathnayake, Assoc Prof","University of Helsinki","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":36,"email":59},"Mikko Kylmänen","CONTACT","+358407245934","mikko.kylmanen@koitehealth.com",[61],{"facility":62,"status":63,"city":64,"state":36,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Södertandläkarna AB","RECRUITING","Stockholm","11622","Sweden","SE",{"type":69,"coordinates":70},"Point",[71,72],18.06871,59.32938,{"lat":72,"lon":71},[75],{"name":76,"role":57,"phone":36,"phoneExt":36,"email":36},"Nilminie Rathnayake, Periodontist",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Nilminie Rathnayake","Principal Investigator",[82],{"name":52,"class":83},"OTHER","100517459","antibacterial-photodynamic-therapy-in-the-management-of-peri-implantitis-100517459",false,"NCT06017817","Antibacterial Photodynamic Therapy in the Management of Peri-implantitis","Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis","Inclusion Criteria:\n\n* PPD ≥6 mm and marginal bone loss \\>3 mm\n* Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22\n* Agreement to participate in the study and to sign a written consent form\n* Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol\n\nExclusion Criteria:\n\n* Presence of any physical limitation or restriction that might restrict Lumoral use\n* Unwilling to participate in the study\n* Pregnancy or lactation\n* Active smoking\n* Medicated diabetes mellitus (DM)\n* Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis\n* Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation\n* Peri-implant and periodontal treatment within 3 months prior to study participation\n* Removable major prosthesis or major orthodontic appliance","ALL","18 Years","85 Years",{"count":95,"type":96},80,"ESTIMATED","INTERVENTIONAL",[99],"NA","This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.",[102,103],"Peri-Implantitis","Plaque, Dental",[105,106,107,108,109],"Lumoral","Lumorinse","Antibacterial photodynamic therapy (aBPT)","aMMP-8","Plaque control","2024-10-16",{"date":112,"type":113},"2024-10-18","ACTUAL",{"date":115,"type":113},"2024-05-13",{"date":117,"type":96},"2026-12-31",{"name":79,"class":6},1]