Actively Recruiting
Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy
Led by University Hospital Heidelberg · Updated on 2026-03-02
60
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with localized or generalized Stage III or IV periodontitis
- Able to give informed consent
- Provided written informed consent including data protection agreement
You will not qualify if you...
- Pregnancy or breastfeeding
- Conditions or medications affecting oral microbiome or healing (e.g., uncontrolled diabetes, immunosuppression, chronic steroid use)
- Antibiotic use within the last 3 months
- Use of oral prebiotic or probiotic supplements within the last 3 months
- Subgingival instrumentation within the last 6 months
- Need for systemic antibiotic prophylaxis or therapy for NSPT
- Severe active systemic infections or other high-risk conditions
- Regular use of antiseptic mouthrinses during the study unless medically necessary
- Strict diets that significantly alter the microbiome (e.g., ketogenic, strict vegan)
- Chronic bowel diseases affecting systemic health
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
Research Team
D
Diana Wolff, Prof. Dr.
CONTACT
V
Valentin Bartha, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here