Oral-spray Bacillus Probiotics to Help Prevent and Support Treatment of Cavities in Children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial will enroll 130 children aged 7-10 with diagnosed dental caries. Participants will be stratified by age and decayed teeth, then assigned to receive either the probiotic spray or a saline placebo twice daily for 3 months. The study aims to assess safety and potential reductions in pathogenic bacteria and caries progression, alongside improvements in clinical symptoms. It builds on previous probiotic research and explores a novel oral-spray formulation of Bacillus strains. Outcomes will inform whether this approach can stabilize the oral microbiome and reduce caries recurrence in children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children (male or female) aged 7-10 years, currently enrolled in primary school (grades 2-4).
* At least one decayed tooth (any stage) at the time of screening.
* Commitment to comply with study requirements, including refraining from using any other probiotic products for the ear, nose, and throat that could affect study outcomes.
* Written informed consent obtained from a parent or legal guardian.

Exclusion Criteria:

Participant-level exclusion:

* Presence of severe chronic disease, allergy, or use of antibiotics within 1 month prior to study initiation.
* Use of oral or throat probiotic sprays/lozenges within the past 30 days (excluding gastrointestinal probiotics).
* Participation in another clinical study within the past 30 days.
* Acute oral conditions (e.g., abscess, severe gingivitis) interfering with examination or intervention.
* Currently receiving dental treatment at specialized dental/oral health facilities.
* History of congenital immunodeficiency or infectious disease.
* Psychiatric disorders or sleep disturbances.
* Known sensitivity or allergy to components of the investigational product.

Tooth-level exclusion:

* Hard tissue lesions not caused by dental caries.
* Supernumerary teeth or teeth not part of the functional dental arch.
* Carious teeth with pain lasting \>10 seconds during examination.
* Carious teeth with visible pulp hyperemia (high risk of pulp complications).
* Teeth showing signs of pulp disease, pulp necrosis, or periapical pathology.
* Teeth previously treated with endodontic therapy or permanently restored with crowns.
* Primary teeth with mobility grade ≥2 (due to disease or natural exfoliation).

Where it's running

• Thanh My Primary School
  Hà Nội, Sơn Tây, Vietnam Recruiting

Study contacts

• Principal investigator: Thu TH Nguyen, Assoc. Prof. — Hanoi Medical University
• Study coordinator: Nga TT Pham, PhD. MD
• Email: Tuyetnga@hmu.edu.vn
• Phone: (84) 0983042975

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.