Oral-Spray Bacillus Spore Probiotic in Preventing and Supporting Treatment of Dental Caries in Children
ConditionDental Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-10
SponsorAnabio R&D
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
oral-spray 0.9% NaCl physiological saline solution
DrugThe 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.
Smile Care
Combination productLiveSpo® 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).
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Smile CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Decayed Teeth Index
Changes will be calculated for each participant based on the following parameters: the number of decayed teeth assessed using the International Caries Detection and Assessment System (ICDAS, codes 0-6), progressive caries rate, early caries rate, and early caries rate (code 1). These parameters will be evaluated at month 3 compared with day 0. Month 1 and Month 2 will be collected as supplementary exploratory timepoints.
Time frame
Day 0, and months 1, 2, 3Secondary outcomes
1
Changes in the concentration of pathogenic bacteria in deep carious dentin and saliva samples
The semi-quantitative assessment of changes in pathogenic bacteria concentrations (S. mutans, P. gingivalis, and A. actinomycetemcomitans) at month 3 compared with day 0, supplementary timepoints (month 1,2).
Time frame
Day 0 and months 1, 2, 32
Changes in Inflammatory Cytokines and IgA levels in deep carious dentin and saliva samples
Measurement of pro-inflammatory cytokine (IL-1β, IL-5, IL-6, IL-8, IL-17, TNF-α or IFN-γ) and IgA concentrations at day 0 and month 3, supplementary timepoints (month 1,2).
Time frame
Day 0 and months 1, 2, 3Other outcomes
1
Changes in the oral microbiome at month 1 compared to day 0
Analysis of the diversity and taxonomy compositions (16S rRNA NGS) of deep carious dentin and saliva samples
Time frame
Day 0 and 1 month2
Detection of Probiotic Bacillus Spores
Detection of Bacillus subtilis and Bacillus clausii spores in the deep carious dentin and saliva at months 1, 2, and 3 using real-time PCR, based on cycle threshold (Ct) values for qualitative assessment of presence.
Time frame
Day 0 and months 1, 2, 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Anabio R&D
Lead sponsor
Hanoi Medical University
Collaborator
Source ClinicalTrials.gov