Serum vitamin B12 is inversely associated with periodontal progression and risk of tooth loss: a prospective cohort study.
Geng Zong, Birte Holtfreter, Ann E Scott...
https://pubmed.ncbi.nlm.nih.gov/26613385Actively Recruiting
Led by University Hospital Heidelberg · Updated on 2026-03-02
60
Participants Needed
1
Research Sites
N/A
Total Duration
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
Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive guideline-concordant non-surgical periodontal therapy including mechanical subgingival instrumentation and risk-factor-oriented oral hygiene instruction. Depending on study arm, participants may take a probiotic lozenge alone or combined with vitamin B12 drops for 3 months starting with therapy.
Baseline NSPT instrumentation visit and approximately 3 months of supplementation
Duration - Up to 9 months after treatment
Participants receive follow-up supportive periodontal therapy (maintenance) as part of routine care, including oral hygiene instruction and professional care aligned with standard practice. This phase includes clinical assessments and microbiome sampling to monitor treatment effects.
Approximately 3 follow-up visits at ~3 months, ~6 months, and ~12 months after baseline
Total: 1 location
1
Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
D
Diana Wolff, Prof. Dr.
V
Valentin Bartha, Dr.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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