[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627036":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":17,"centralContacts":38,"locations":48,"responsibleParty":72,"collaborators":17,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":17,"enrollmentInfo":86,"targetDuration":17,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":51,"whyStopped":17,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Guideline-concordant non-surgical periodontal therapy including mechanical subgingival instrumentation and risk-factor-oriented oral hygiene instruction, followed by supportive periodontal therapy (maintenance) as part of routine care. No placebo is used.",[13],"Procedure: Non-surgical periodontal therapy (NSPT) and supportive periodontal therapy (SPT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Test A - Probiotic","EXPERIMENTAL",null,[13,19],"Dietary Supplement: Probiotic lozenge (Limosilactobacillus reuteri; GUM® PerioBalance®)",{"label":21,"type":16,"description":17,"interventionNames":22},"Test B - Synbiotic-like: Probiotic + Vitamin B12",[13,19,23],"Dietary Supplement: Vitamin B12 drops (natural elements)",[25,29,34],{"type":26,"name":27,"description":11,"armGroupLabels":28,"otherNames":17},"PROCEDURE","Non-surgical periodontal therapy (NSPT) and supportive periodontal therapy (SPT)",[9,15,21],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":17},"DIETARY_SUPPLEMENT","Probiotic lozenge (Limosilactobacillus reuteri; GUM® PerioBalance®)","Commercial dietary supplement lozenge containing Limosilactobacillus reuteri (GUM® PerioBalance®, Sunstar Deutschland GmbH, Schönau, Germany). Administered orally according to manufacturer instructions for 3 months starting with NSPT.",[15,21],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"Vitamin B12 drops (natural elements)","Commercial dietary supplement vitamin B12 drops (natural elements GmbH, Düsseldorf, Germany). Administered orally according to manufacturer instructions for 3 months, in addition to the probiotic regimen, starting with NSPT.",[21],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":17,"email":43},"Diana Wolff, Prof. Dr.","CONTACT","00496221566002","diana.wolff@med.uni-heidelberg.de",{"name":45,"role":41,"phone":46,"phoneExt":17,"email":47},"Valentin Bartha, Dr.","004962215639888","valentin.bartha@med.uni-heidelberg.de",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Heidelberg University Hospital","RECRUITING","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":58,"coordinates":59},"Point",[60,61],8.69079,49.40768,{"lat":61,"lon":60},[64,67,70],{"name":65,"role":41,"phone":42,"phoneExt":17,"email":66},"Tanja Schamma","tanja.schamma@med.uni-heidelberg.de",{"name":68,"role":69,"phone":17,"phoneExt":17,"email":17},"Joel Hettler","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":17,"phoneExt":17,"email":17},"Valentin Bartha",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Diana Wolff","Professor Dr. med. dent.","100627036","microbiological-and-clinical-effects-of-pre--and-probiotics-in-non-surgical-periodontal-therapy-100627036",false,"NCT07443410","Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy","PROPARO","Inclusion Criteria:\n\n* Age ≥ 18 years\n\n  * Stage III or IV periodontitis (localized or generalized)\n  * Ability to provide informed consent\n  * Written informed consent including data protection consent\n\nExclusion Criteria:\n\n* • Pregnancy or breastfeeding\n\n  * Conditions\u002Fmedications likely to substantially confound the oral microbiome or periodontal healing (e.g., uncontrolled diabetes mellitus, systemic immunosuppression, chronic steroid use)\n  * Antibiotic use within the last 3 months\n  * Use of oral pre-\u002Fprobiotic supplements within the last 3 months\n  * Recent subgingival instrumentation within the last 6 months\n  * Need for obligatory adjunctive systemic antibiotic prophylaxis\u002Ftherapy for NSPT\n  * Severe active systemic infection or other conditions judged by investigators to pose undue risk\n  * Regular use of antiseptic mouthrinses during the study period (unless medically required)\n  * Strict diets likely to substantially alter baseline microbiome trajectories (e.g., ketogenic, strict vegan) per protocol definition\n  * Chronic bowel diseases (for systemic confounding considerations)",true,"ALL","18 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"NA","Periodontitis is a prevalent chronic inflammatory disease driven by a dysbiotic oral biofilm and a dysregulated host immune response. Standard non-surgical periodontal therapy (NSPT) is primarily mechanical and, in selected cases, may be accompanied by antiseptics or systemic antibiotics. Targeted modulation of the oral microbiome (\"microbiome engineering\") is currently not part of routine periodontal care due to limited high-quality evidence.\n\nPROPARO is a single-center, randomized, controlled pilot study designed to assess whether adjunctive oral supplementation with a probiotic containing Limosilactobacillus reuteri (commercial dietary supplement lozenge) alone or combined with vitamin B12 (commercial dietary supplement drops) is associated with changes in supragingival and subgingival oral microbiome composition during guideline-concordant NSPT compared with standard care alone. Participants with Stage III or IV periodontitis will be randomized 1:1:1 to: (1) NSPT\u002FSPT without supplementation (control), (2) NSPT\u002FSPT plus probiotic lozenges for 3 months, or (3) NSPT\u002FSPT plus probiotic lozenges and vitamin B12 drops for 3 months.\n\nThe primary outcome is change in oral microbiome composition and structure (supragingival and subgingival), assessed using 16S rDNA-based profiling and metagenomic sequencing approaches. Secondary outcomes include clinical periodontal parameters (e.g., probing depth, clinical attachment level, bleeding on probing), oral hygiene\u002Fgingival indices, dental status, and participant-level ecological covariates (diet quality, perceived stress, physical activity). Sampling and assessments are aligned with routine care time points from baseline through supportive periodontal therapy follow-up (up to 12 months). This pilot trial aims to generate feasibility and effect-size estimates to inform future confirmatory studies and potential translation into guideline-based periodontal care.",[94,95,96],"Periodontitis, Adult","Periodontitis (Stage 3)","Periodontitis Stage IV",[98,99,100,101,102],"Periodontitis","Non-surgical periodontal treatment","Probiotics","Prebiotics","Oral Microbiome","2026-02-24",{"date":105,"type":106},"2026-03-02","ACTUAL",{"date":108,"type":106},"2024-10-25",{"date":110,"type":88},"2026-10",{"name":5,"class":6},1]