RecruitingNot ApplicableNCT07241052

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

Evaluating Safety and Efficacy of Oral-Spray Bacillus Probiotic (LiveSpo® Smile CARE) in the Prevention and Adjunctive Treatment of Dental Caries in Children

Sponsor

Anabio R&D

Enrollment

130 participants

Start Date

Mar 5, 2026

Study Type

INTERVENTIONAL

Conditions

Dental Caries

Summary

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 ANA48 and Bacillus clausii ANA39 (LiveSpo® Smile CARE) in preventing and supporting the treatment of tooth decay in children. We hypothesize that this probiotic spray, when used regularly, will be safe and well-tolerated, while effectively reducing harmful bacteria in the mouth, preventing the progression of cavities, and improving overall oral health. Study Design: * Sample Size: 130 participants * Study Location: a primary school in Hanoi, Vietnam Intervention Description: A total of 130 eligible participants will be randomly assigned to two groups (n = 65 per group). Placebo Group will receive a 0.9% NaCl physiological saline, spray twice daily (morning and afternoon). Each application consists of two sprays at three sites (both dental arches and the front teeth), for a total of six sprays per use, continued for three consecutive months. Smile Care Group will receive an oral-spray probiotics containing ≥ 1 billion CFU/mL × 20 mL of Bacillus subtilis and Bacillus clausii (LiveSpo Smile CARE). The dosage, frequency, and duration of use will be the same as in the placebo group. All participants will receive the same standard dental care throughout the study, including the use of identical toothpaste, supervised weekly fluoride rinsing with 0.2% sodium fluoride (NaF), and scheduled follow-up visits. The probiotic and placebo sprays will be packaged in blinded bottles and administered according to the study protocol to maintain objectivity. Study Duration: 12-18 months

Eligibility

Min Age: 7 YearsMax Age: 10 Years

Inclusion Criteria4

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 Criteria15

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.
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).

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Interventions

DRUGoral-spray 0.9% NaCl physiological saline solution

The oral-spray 0.9% NaCl physiological saline is prepared by extracting 20 mL from a 500 mL polypropylene bottle of 0.9% NaCl intravenous infusion (B. Braun, Germany; product declaration No. VD-32732-19). The solution is contained in an opaque plastic spray bottle identical to that used for the Smile Care.

COMBINATION_PRODUCTSmile Care

LiveSpo® Smile CARE is manufactured as a Class-A medical device (product declaration No. 250002196/PCBA-HN) in compliance with manufacturing standards approved by the Hanoi Department of Health, Ministry of Health. The product is formulated as a 0.9% NaCl physiological saline solution plus Bacillus subtilis ANA48 and Bacillus clausii ANA39 at total concentration of ≥ 1 × 10⁹ CFU/mL (20 billion CFU/20 mL suspension).