Microbiological and Clinical Effects of Pre- and Probiotics in Non-Surgical Periodontal Therapy

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

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.

It had three arms (groups): Control (active comparator), Test A - Probiotic (experimental) and Test B - Synbiotic-like: Probiotic + Vitamin B12 (experimental).

Guideline-concordant non-surgical periodontal therapy including mechanical subgingival instrumentation and risk-factor-oriented oral hygiene instruction, followed by supportive periodontal therapy (maintenance) as part of routine care. No placebo is used.

The registry classes the interventions as dietary supplement and procedure.

More on the Plan

Background and rationale: Periodontitis is a chronic inflammatory disease characterized by periodontal pocketing, bleeding on probing, and progressive loss of periodontal supporting tissues, potentially resulting in tooth loss and impaired oral function.

The disease is initiated and sustained by a dysbiotic biofilm in combination with an exaggerated or dysregulated host response.

Current guideline-concordant non-surgical periodontal therapy (NSPT) targets biofilm removal by mechanical debridement and risk-factor control.

Although antiseptics or systemic antibiotics may be used in selected indications, routine, targeted manipulation of the oral microbiome is not established because available evidence is heterogeneous and mechanistic data on whole-community changes remain limited.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age ≥ 18 years. Stage III or IV periodontitis (localized or generalized). Ability to provide informed consent. Written informed consent including data protection consent.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: • 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2024-10-25 with completion listed for 2026-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in oral microbiome composition (supragingival and subgingival) (time frame: Baseline through 12 months (assessed at baseline, NSPT instrumentation visit, ~3 months, ~6 months, and ~12 months)).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.