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Oral-Spray Bacillus Spore Probiotic in Preventing and Supporting Treatment of Dental Caries in Children

RecruitingNAAges 7 Years - 10 YearsAllAnabio R&D
NCT07241052 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Despite advances in oral health care, cavities remain highly prevalent worldwide, especially among children. Conventional treatment methods focus on removing damaged tooth tissue but fail to completely eliminate or control pathogenic bacteria in the oral cavity, leading to a high risk of caries recurrence in the same or adjacent teeth. Probiotics are a promising biological therapy that can help restore balance in the oral microbiome. Among probiotics, Bacillus species are unique because they form spores that make them stable under harsh conditions, such as heat and storage. They can also produce enzymes and natural compounds with antibacterial, anti-inflammatory, and protective effects. These features make Bacillus probiotics strong candidates for oral health applications. This study is designed to evaluate the safety and efficacy of an oral-spray probiotic containing Bacillus subtilis

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ2 (due to disease or natural exfoliation).
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What it tests

  • oral-spray 0.9% NaCl physiological saline solution
  • Smile Care
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Where

1 site
Thanh My Primary School
Hร  Nแป™i, Vietnam
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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