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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Periodontitis is a common chronic inflammatory disease caused by an imbalance in the oral biofilm and an abnormal immune response. Researchers are evaluating whether adding oral supplements containing a probiotic called Limosilactobacillus reuteri alone or combined with vitamin B12 can change the composition of the oral microbiome during standard non-surgical periodontal therapy NSPT and follow-up care. This single-center, randomized pilot study aims to generate initial data on these effects compared to standard care alone for adults with Stage III or IV periodontitis. Participants will receive routine guideline-based NSPT including mechanical cleaning and oral hygiene instructions, followed by supportive periodontal therapy SPT. They will be randomly assigned to one of three groups standard therapy without supplements, therapy plus probiotic lozenges for 3 months, or therapy plus probiotic lozenges and vitamin B12 drops for 3 months. No placebo is used, and supplements are given according to manufacturer instructions alongside standard care. During the study, participants will undergo clinical assessments, questionnaires, and collection of saliva and dental plaque samples at baseline, during NSPT visits, and at follow-ups around 3, 6, and 12 months. Researchers will analyze changes in the oral microbiome using advanced DNA sequencing techniques, as well as clinical periodontal health measures such as probing depth and bleeding. Participants will be monitored for any adverse effects related to supplements, and data will be collected to support future research and potential improvements in periodontal care.
CONDITIONS
Brief 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 Stage III or IV periodontitis (localized or generalized)
- Ability to provide informed consent
- Written informed consent including data protection consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Conditions or medications likely to affect oral microbiome or healing (e.g., uncontrolled diabetes, immunosuppression, chronic steroid use)
- Antibiotic use within the last 3 months
- Use of oral pre-/probiotic supplements within the last 3 months
- Subgingival dental cleaning within the last 6 months
- Need for mandatory systemic antibiotic therapy for periodontal treatment
- Severe active systemic infection or other conditions posing undue risk
- Regular use of antiseptic mouthrinses during the study unless medically required
- Strict diets likely to alter oral microbiome (e.g., ketogenic, strict vegan)
- Chronic bowel diseases affecting systemic health
Research Team
D
Diana Wolff, Prof. Dr.
V
Valentin Bartha, Dr.
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