Evaluating Safety and Efficacy of Oral-Spray Bacillus Probiotic (LiveSpo® Smile CARE) in the Prevention and Adjunctive Treatment of Dental Caries in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Anabio R&D
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Decayed Teeth Index
研究概览
简要总结
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
详细描述
Tooth decay is one of the most common oral health problems in children. It not only causes pain and discomfort but also interferes with eating, daily activities, and overall quality of life. In severe cases, untreated cavities may progress to pulp infection requiring more complex treatment. One of the major causes of dental caries is an imbalance of the oral microbiome, with Streptococcus mutans being the main pathogen. Improving the oral microbiome provides a safe, long-term strategy for managing cavities, particularly in children, while avoiding the risks of antibiotic resistance.
Bacillus probiotics have been extensively studied for their benefits on gastrointestinal and respiratory health but remain underexplored in the context of oral health. This trial is among the first to evaluate the safety and potential synergistic effects of Bacillus subtilis and Bacillus clausii in improving clinical symptoms, reducing pathogenic bacterial load, and preventing the progression of dental caries after 1, 2, and 3 months of intervention.
This is a randomized, double-blind, placebo-controlled clinical trial conducted over 3 months. A total of 130 primary school children aged 7-10 years (grades 2-4) with diagnosed dental caries will be enrolled. Children will be stratified by age group (7-<8, 8-<9, 9-10 years) and number of decayed teeth (≤2 or >2), then randomized in a 1:1 ratio to receive either: Placebo group and Smile Care group.
Both sprays will be administered twice daily (morning and afternoon), two sprays per site (both dental arches and front teeth), totaling six sprays per use, for three consecutive months.
- Primary Outcome: Changes in clinical symptoms, including Decayed Teeth index using ICDAS classification, Progressive caries rate, Early caries rate and Early caries rate code 1) at months 1 and 3 vs. day 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
LiveSpo Smile CARE and placebo are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Smile CARE suspension are unrecognizable to investigators, trainers, caregivers, and paticipants due to opaque plastic container. Only the independent statistician is aware of the group codes.
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Smile Care
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.
干预措施: Smile Care (Combination Product)
Placebo
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.
干预措施: oral-spray 0.9% NaCl physiological saline solution (Drug)
结局指标
主要结局
Decayed Teeth Index
时间窗: Day 0, and months 1, 2, 3
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.
次要结局
- Changes in the concentration of pathogenic bacteria in deep carious dentin and saliva samples(Day 0 and months 1, 2, 3)
- Changes in Inflammatory Cytokines and IgA levels in deep carious dentin and saliva samples(Day 0 and months 1, 2, 3)