[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611474":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":42,"locations":50,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":26,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Anabio R&D","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","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.",[13],"Drug: oral-spray 0.9% NaCl physiological saline solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Smile Care","EXPERIMENTAL","Children will receive LiveSpo® Smile CARE, an oral-spray probiotic containing ≥ 1 × 10⁹ CFU\u002F 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.",[19],"Combination Product: Smile Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","oral-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.",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"COMBINATION_PRODUCT","LiveSpo® Smile CARE is manufactured as a Class-A medical device (product declaration No. 250002196\u002FPCBA-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\u002FmL (20 billion CFU\u002F20 mL suspension).",[15],[32,36,39],{"name":33,"affiliation":34,"role":35},"Nga TT Pham, PhD. MD","Hanoi Medical University","STUDY_CHAIR",{"name":37,"affiliation":34,"role":38},"Thu TH Nguyen, Assoc. Prof.","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Anh TV Nguyen, Assoc. Prof.","Spobio Research Center, Anabio R&D",[43,47],{"name":33,"role":44,"phone":45,"phoneExt":26,"email":46},"CONTACT","(84) 0983042975","Tuyetnga@hmu.edu.vn",{"name":37,"role":44,"phone":48,"phoneExt":26,"email":49},"(84) 0903211266","nguyenhoaithu@hmu.edu.vn",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Thanh My Primary School","RECRUITING","Hà Nội","Sơn Tây","100000","Vietnam","VN",{"type":60,"coordinates":61},"Point",[62,63],106.02292,20.47366,{"lat":63,"lon":62},[66],{"name":67,"role":44,"phone":68,"phoneExt":69,"email":70},"Oanh T Dao","02433838041","0987899089","c1thanhmy-st@hanoiedu.vn",{"type":72,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[74],{"name":34,"class":75},"OTHER","100611474","oral-spray-bacillus-spore-probiotic-in-preventing-and-supporting-treatment-of-dental-caries-in-children-100611474",false,"NCT07241052","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","Inclusion Criteria:\n\n* Children (male or female) aged 7-10 years, currently enrolled in primary school (grades 2-4).\n* At least one decayed tooth (any stage) at the time of screening.\n* 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.\n* Written informed consent obtained from a parent or legal guardian.\n\nExclusion Criteria:\n\nParticipant-level exclusion:\n\n* Presence of severe chronic disease, allergy, or use of antibiotics within 1 month prior to study initiation.\n* Use of oral or throat probiotic sprays\u002Flozenges within the past 30 days (excluding gastrointestinal probiotics).\n* Participation in another clinical study within the past 30 days.\n* Acute oral conditions (e.g., abscess, severe gingivitis) interfering with examination or intervention.\n* Currently receiving dental treatment at specialized dental\u002Foral health facilities.\n* History of congenital immunodeficiency or infectious disease.\n* Psychiatric disorders or sleep disturbances.\n* Known sensitivity or allergy to components of the investigational product.\n\nTooth-level exclusion:\n\n* Hard tissue lesions not caused by dental caries.\n* Supernumerary teeth or teeth not part of the functional dental arch.\n* Carious teeth with pain lasting \\>10 seconds during examination.\n* Carious teeth with visible pulp hyperemia (high risk of pulp complications).\n* Teeth showing signs of pulp disease, pulp necrosis, or periapical pathology.\n* Teeth previously treated with endodontic therapy or permanently restored with crowns.\n* Primary teeth with mobility grade ≥2 (due to disease or natural exfoliation).",true,"ALL","7 Years","10 Years",{"count":88,"type":89},130,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.\n\nAmong 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.\n\nThis 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.\n\nStudy Design:\n\n* Sample Size: 130 participants\n* 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).\n\nPlacebo 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.\n\nSmile Care Group will receive an oral-spray probiotics containing ≥ 1 billion CFU\u002FmL × 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.\n\nAll 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.\n\nStudy Duration: 12-18 months",[95],"Dental Caries",[97,98,99,100,101,102],"Dental caries","Children","probiotics","Oral health","Oral-spray","Bacillus spores","2026-06-04",{"date":105,"type":106},"2026-06-05","ACTUAL",{"date":108,"type":106},"2026-03-05",{"date":110,"type":89},"2027-05-01",{"name":5,"class":6},1]