Probiotics with or without vitamin B12 added to non-surgical treatment for advanced periodontitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PROPARO is a single-center, randomized, controlled pilot trial enrolling adults with Stage III or IV periodontitis to compare guideline-concordant non-surgical periodontal therapy (NSPT) alone versus NSPT with a Limosilactobacillus reuteri lozenge or NSPT plus the lozenge and vitamin B12 drops. Participants are randomized 1:1:1 and receive standard mechanical debridement and supportive periodontal therapy while supplementing according to their assigned arm. The study collects supragingival and subgingival samples to characterize microbiome composition and tracks clinical periodontal measures over the treatment period. The goal is to determine community-level microbial changes and whether adjunctive supplements produce measurable differences compared with standard care.

Why it matters

Who can join: the full rules

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)

Where it's running

• Heidelberg University Hospital
  Heidelberg, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Study coordinator: Diana Wolff, Prof. Dr.
• Email: diana.wolff@med.uni-heidelberg.de
• Phone: 00496221566002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Omega-3s and low-dose aspirin for smokers with stage III periodontitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.