At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating Safety and Efficacy of Oral-Spray Bacillus Probiotic (LiveSpo® Smile CARE) in the Prevention and Adjunctive Treatment of Dental Caries in Children
In Brief
A clinical study evaluating oral-spray 0.9% NaCl physiological saline solution and Smile Care for Dental Caries. Currently recruiting, targeting 130 participants across 1 site.
Detailed 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
Study Details
Timeline
Arms & Interventions
Participants allocated to the placebo group will receive a 0.9% NaCl physiological saline spray (20 mL bottle). The spray will be applied directly to carious teeth and adjacent teeth, with a total of six sprays per application, administered twice daily (morning and afternoon), under teacher supervision. All participants will maintain identical daily oral hygiene practices, including the use of fluoride toothpaste and supervised rinsing with 0.2% sodium fluoride mouthwash once per week. The intervention will be continued for a duration of 3 months.
Children will receive LiveSpo® Smile CARE, an oral-spray probiotic containing ≥ 1 × 10⁹ CFU/ mL Bacillus subtilis and Bacillus clausii in 20 mL of 0.9% sodium chloride solution. The spray will be administered with the same dosage, frequency, timing, and supervision as the placebo group. The intervention will be continued for a duration of 3 months.
Interventions
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.
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).