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Gum disease breakthrough? probiotics and B12 under the microscope

NCT ID NCT07443410

Knowledge-focused Sponsor: University Hospital Heidelberg Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether taking probiotics (with or without vitamin B12) can improve the health of the mouth's bacteria and reduce gum disease in adults with severe periodontitis. Participants will receive standard gum treatment plus either a probiotic lozenge, a probiotic with vitamin B12 drops, or no supplement for 3 months. The goal is to see if these supplements help the standard treatment work better by changing the bacteria in the mouth.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Stage III or IV periodontitis (localized or generalized) * Ability to provide informed consent * Written informed consent including data protection consent Exclusion Criteria: * • 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 * Use of oral pre-/probiotic supplements within the last 3 months * Recent subgingival instrumentation within the last 6 months * Need for obligatory adjunctive systemic antibiotic prophylaxis/therapy for NSPT * Severe active systemic infection or other conditions judged by investigators to pose undue risk * Regular use of antiseptic mouthrinses during the study period (unless medically required) * Strict diets likely to substantially alter baseline microbiome trajectories (e.g., ketogenic, strict vegan) per protocol definition * Chronic bowel diseases (for systemic confounding considerations)

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Conditions

The condition(s) this trial relates to.

chronic periodontitis periodontitis periodontitis, chronic, adult

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Periodontitis (stage 3) Periodontitis stage IV Periodontitis, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Heidelberg University Hospital

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69120, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.