protocolSection identificationModule nctId: NCT06286501, orgStudyIdInfo id: R23060L, briefTitle: Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases, acronym: LumoPrevent, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Wellbeing Services County of Pirkanmaa, class: OTHER, collaborators name: Tampere University, collaborators name: University of Helsinki, collaborators name: Metropolia University of Applied Sciences, descriptionModule briefSummary: The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging., conditionsModule conditions: Dental Caries in Children, conditions: Dental Plaque, conditions: Tooth Decay, conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical study on a CE-approved medical device, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Lumoral Treatment, interventions name: Standard, personalized oral health care, outcomesModule primaryOutcomes measure: Bleeding on probing (BOP), primaryOutcomes measure: Bleeding on probing (BOP), secondaryOutcomes measure: Active matrix metalloproteinase 8 (aMMP-8), secondaryOutcomes measure: Probing Pocket Depth (PPD), secondaryOutcomes measure: Probing Pocket Depth (PPD), secondaryOutcomes measure: Visible plaque index (VPI), secondaryOutcomes measure: Visible plaque index (VPI), secondaryOutcomes measure: Decayed tooth assessment (DT), secondaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Microbiological evaluation/16S rRNA analysis, secondaryOutcomes measure: Microbiological evaluation/16S rRNA analysis, secondaryOutcomes measure: Oral-related quality of life measurement (OHIP-14), secondaryOutcomes measure: Absence of adverse effects, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Wellbeing Services of County Pirkanmaa, city: Tampere, state: Pirkanmaa, zip: 33520, country: Finland, contacts name: Milla Sarja, dentist, role: CONTACT, phone: +358405337979, email: milla.sarja@pirha.fi, contacts name: Mikko Kylmänen, role: CONTACT, email: mikko.kylmanen@metropolia.fi, contacts name: Anna Maria Heikkinen, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 61.49911, lon: 23.78712, hasResults: False