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Probiotic pill may fight gum problems for people with braces

NCT ID NCT06752330

Disease control Sponsor: University of Turin, Italy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether taking a daily probiotic (Bifidobacterium Lactis HN019) can reduce plaque buildup and gum bleeding in people undergoing orthodontic treatment with braces or clear aligners. Sixty participants, aged 10 to 30, took the probiotic or a placebo for a period while researchers measured gum health. The goal was to see if this simple addition to oral hygiene could help prevent common dental issues during orthodontic care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bifidobacterium Lactis HN019 probiotic (with Kluyveromyces Marxianus Fragilis B0399, colostrum, and biotin)
What this could lead to
If it works, this could point toward a simple way to improve gum health during orthodontic treatment.
What could go wrong
This is a small, completed trial with only 60 participants, so results may not apply to everyone. The effect on plaque and bleeding may be modest or not clinically significant.

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

60 people

The number who actually took part.

Started

Jan 2025

Finished

Jun 2025

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

10 to 30 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 range of 10 to 30 years old; * good general health; * patients undergoing fixed multibracket orthodontic treatment; * patients undergoing invisible aligner orthodontic treatment. Exclusion Criteria: * physical, mental or motor disabilities; * systemic conditions that influence the progression of gingivitis; * presence of non-plaque-induced gingivitis; * known allergies; * smokers (if more than 5 cigarettes per day); * use of antibiotics, anti-inflammatories, or probiotics in the 6 months prior to recruitment.

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Conditions

The condition(s) this trial relates to.

gingivitis periodontal disorder

As listed by the trial registrant

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

Dental hygiene Gingivitis and periodontal diseases Orthodontics

Contacts and locations

Locations

  • AOU Città della Salute e della Scienza

    Torino, Italy, 10126, Italy

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