Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07443410

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Supportive Periodontal Therapy

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

Trial Site Locations

Total: 1 location

1

Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

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Research Team

D

Diana Wolff, Prof. Dr.

V

Valentin Bartha, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

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/26613385

Nutritional stimulation of commensal oral bacteria suppresses pathogens: the prebiotic concept.

Vera Slomka, Emma Hernandez-Sanabria, Esteban Rodriguez Herrero...

https://pubmed.ncbi.nlm.nih.gov/28128467

Clinical and Biochemical Evaluation of Lozenges Containing Lactobacillus reuteri as an Adjunct to Non-Surgical Periodontal Therapy in Chronic Periodontitis.

Gizem İnce, Hare Gürsoy, Şebnem Dirikan İpçi...

https://pubmed.ncbi.nlm.nih.gov/25741580

Clinical and microbiological effects of probiotic lozenges in the treatment of chronic periodontitis: a 1-year follow-up study.

Merve Tekce, Gizem Ince, Hare Gursoy...

https://pubmed.ncbi.nlm.nih.gov/25728888

Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study.

Wim Teughels, Andaç Durukan, Onur Ozcelik...

https://pubmed.ncbi.nlm.nih.gov/24164569

Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics.

Glenn R Gibson, Robert Hutkins, Mary Ellen Sanders...

https://pubmed.ncbi.nlm.nih.gov/28611480

Effect of professional mechanical plaque removal performed on a long-term, routine basis in the secondary prevention of periodontitis: a systematic review.

Leonardo Trombelli, Giovanni Franceschetti, Roberto Farina

https://pubmed.ncbi.nlm.nih.gov/25495875