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Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy

RecruitingNAAges 18 Years - anyAllUniversity Hospital Heidelberg
NCT07443410 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. PROPARO 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. Part

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Stage III or IV periodontitis (localized or generalized) * Ability to provide informed consent * Written informed consent including data protection consent Exclusion Criteria: * • Pregnancy or breastfeeding * Conditions/medications likely to substantially confound the oral microbiome or periodontal healing (e.g., uncontrolled diabetes mellitus, systemic immunosuppression, chronic steroid use) * Antibiotic use within the last 3 months * Use of oral pre-/probiotic supplements within the last 3 months * Recent subgingival instrumentation within the last 6 months * Need for obligatory adjunctive systemic antibiotic prophylaxis/therapy for NSPT * Severe active systemic infection or other conditions judged by investigators to pose undue risk * Regular use of antiseptic mouthrinses during the study period (unless medically required) * Strict diets likely to substantially alter baseline microbiome trajectories (e.g., ketogenic, strict vegan) per protocol definition * Chronic bowel diseases (for systemic confounding considerations)
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What it tests

  • Non-surgical periodontal therapy (NSPT) and supportive periodontal therapy (SPT)
  • Probiotic lozenge (Limosilactobacillus reuteri; GUM® PerioBalance®)
  • Vitamin B12 drops (natural elements)
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Where

1 site
Heidelberg University Hospital
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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