[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612801":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":45,"locations":53,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":33,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":33,"enrollmentInfo":87,"targetDuration":33,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":56,"whyStopped":33,"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. The solution will be self-administered via spray, twice daily-once in the afternoon and once at night. At each administration, participants will apply two sprays to each side of the dental arch and two sprays to the incisor region, resulting in a total of six sprays per application. This regimen will be maintained consistently for a period of 4 weeks.",[13],"Drug: oral-spray 0.9% NaCl physiological saline solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Smile Care","EXPERIMENTAL","Participants assigned to the experimental group will receive LiveSpo® Smile CARE (20 mL), formulated as an oral-spray probiotics containing ≥ 1 × 10⁹ CFU\u002F mL of Bacillus subtilis and Bacillus clausii, of 0.9% sodium chloride solution. The suspension will be self-administered via oral spray twice daily once in the afternoon and once at night. At each administration, participants will apply two sprays to each side of the dental arch and two sprays to the incisor region, totaling six sprays per application. The intervention will be continued for a duration of 4 weeks.",[19],"Combination Product: LiveSpo Smile CARE",[21,28],{"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 solution 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 administration of Smile Care.",[9],[27],"Registration number: VD-32723-19",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"COMBINATION_PRODUCT","LiveSpo Smile CARE","LiveSpo Smile CARE is manufactured as a Class-A medical device (product declaration 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 billion CFU\u002F (20 billion CFU\u002F20 mL suspension)",[15],null,[35,39,42],{"name":36,"affiliation":37,"role":38},"Nga TT Pham, PhD. MD","Hanoi Medical University","STUDY_CHAIR",{"name":40,"affiliation":37,"role":41},"Thu TH Nguyen, Assoc. Prof.","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":44,"role":41},"Anh TV Nguyen, Assoc. Prof.","Spobio Research Center, Anabio R&D",[46,50],{"name":36,"role":47,"phone":48,"phoneExt":33,"email":49},"CONTACT","(84) 0983042975","Tuyetnga@hmu.edu.vn",{"name":40,"role":47,"phone":51,"phoneExt":33,"email":52},"(84) 903211266","nguyenhoaithu@hmu.edu.vn",[54],{"facility":55,"status":56,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Tuyet Thai Senior Care Center","RECRUITING","Hanoi","100000","Vietnam","VN",{"type":62,"coordinates":63},"Point",[64,65],105.84117,21.0245,{"lat":65,"lon":64},[68],{"name":69,"role":47,"phone":70,"phoneExt":33,"email":71},"Hai H Nham","0916985638","haildlddaitu@gmail.com",{"type":73,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[75],{"name":37,"class":76},"OTHER","100612801","oral-spray-bacillus-spore-probiotics-for-periodontal-disease-prevention-and-supprotive-treatment-in-the-elderly-100612801",false,"NCT07258303","Oral-Spray Bacillus Spore Probiotics for Periodontal Disease Prevention and Supprotive Treatment in the Elderly","Evaluating Safety and Efficacy of Oral-Spray Bacillus Spore Probiotics (LiveSpo Smile CARE) in Preventing and Supporting the Treatment of Periodontal Diseases in Elderly in Hanoi","Inclusion Criteria\n\n* Patients aged 35 years and older.\n* Patients diagnosed with periodontal disease based on clinical examination, including gingivitis and periodontitis.\n* Patients presenting with at least 10 natural teeth in the dental arch.\n* Patients with stable general health status and able to comply with study procedures.\n* Patients (or their legal guardians) who provide written informed consent and voluntarily agree to participate in the study.\n\nExclusion Criteria\n\n* Patients with unstable general health, acute systemic or oral diseases, or malignant conditions that may interfere with participation.\n* Patients who are currently receiving treatment for periodontal disease at specialized dental facilities.\n* Patients currently using any therapeutic or adjunctive products for the management of periodontal disease.",true,"ALL","35 Years",{"count":88,"type":89},90,"ESTIMATED","INTERVENTIONAL",[92],"NA","Periodontal diseases are strongly associated with dysbiosis of the oral microbiome within the biofilm. Key pathogens, including Streptococcus mutans, Aggregatibacter actinomycetemcomitans, and Porphyromonas gingivalis, contribute to caries progression and periodontal inflammation. Given the limitations of antibiotic use and their potential side effects, probiotics represent a promising biological approach to restore microbial balance and support oral health.\n\nIn this study, researchers propose that direct application of probiotic spray into the oral cavity is safe and effective in alleviating typical symptoms of periodontal disease, particularly by reducing pathogenic bacterial density.\n\nThe objective of this study is to evaluate the safety and efficacy of a oral-spray Bacillus spore probiotics (LiveSpo Smile CARE), containing Bacillus subtilis ANA48 and Bacillus clausii ANA39 at a concentration of ≥ 1 billion CFU\u002FmL x 20 mL formulation, for the prevention and supportive treatment of periodontal disease.\n\nStudy Design:\n\n* Sample Size: 90 participants\n* Study Location: an elderly care center in Hanoi, Vietnam\n\nIntervention Description: A total of 90 eligible participants will be randomly assigned to two groups (n = 45 per group).\n\n* The Placebo Group will receive 0.9% NaCl physiological saline, spray twice daily (afternoon and evening), with two sprays per application at three sites (both dental arches and the front teeth), totaling six sprays per use, for four consecutive weeks.\n* The Smile Care Group will receive an oral-spray probiotics containing ≥ 1 billion CFU\u002FmL × 20 mL of Bacillus subtilis and Bacillus clausii (LiveSpo Smile CARE), administered with the same dosage and frequency as the placebo group.\n\nAll participants will receive blinded, coded spray bottles to ensure objectivity. Both groups will be instructed to use the same standardized toothpaste during the study period. Caregivers will monitor the health status of participants and record relevant information in their medical records. During the study, caregivers will be instructed not to provide any additional probiotic oral care products or the solution contains similar components.\n\nStudy Duration: 12-18 months.",[95,96],"Periodontal Disease","Oral Deseases",[95,98,99,100,101,102],"The elderly","pathogenic bacterial densities","Bacillus","Spores","oral-spray probiotics","2026-01-19",{"date":105,"type":106},"2026-01-21","ACTUAL",{"date":108,"type":106},"2025-12-20",{"date":110,"type":89},"2027-05-01",{"name":5,"class":6},1]