NCT07443410 Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy
| NCT ID | NCT07443410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Periodontitis, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-25 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-25 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Participants with Stage III or IV periodontitis will be randomized 1:1:1 to: (1) NSPT/SPT without supplementation (control), (2) NSPT/SPT plus probiotic lozenges for 3 months, or (3) NSPT/SPT plus probiotic lozenges and vitamin B12 drops for 3 months. The 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/gingival 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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07443410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontitis, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07443410 currently recruiting?
Yes, NCT07443410 is actively recruiting participants. Contact the research team at diana.wolff@med.uni-heidelberg.de for enrollment information.
Where is the NCT07443410 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT07443410 clinical trial?
NCT07443410 is sponsored by University Hospital Heidelberg. The trial plans to enroll 60 participants.