An interventional study of oral-spray 0.9% NaCl physiological saline solution and LiveSpo Smile CARE in Periodontal Disease and Oral Deseases, sponsored by Anabio R&D. Recruiting at 1 site in Vietnam. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Anabio R&D · Not applicable, Interventional, and Prevention
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.
In 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.
The 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/mL x 20 mL formulation, for the prevention and supportive treatment of periodontal disease.
Study Design:
Intervention Description: A total of 90 eligible participants will be randomly assigned to two groups (n = 45 per group).
All 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.
Study Duration: 12-18 months.
According to the World Health Organization (WHO), severe oral disease is estimated to affect over 1 billion individuals worldwide. Studies have demonstrated that the prevalence of periodontal disease increases with age. In Vietnam, oral disease is a common oral health problem among the elderly, with a prevalence rate of approximately 91%. This includes 51.6% presenting with simple gingivitis and 39.4% with periodontitis. If left untreated, oral disease may lead to gingival inflammation, swelling, bleeding, and destruction of the supporting structures of the teeth, resulting in pain during mastication. In severe cases, it can cause tooth loss, systemic infections such as sepsis, and increase the long-term risk of systemic diseases including cardiovascular disease and diabetes.
Conventional treatment primarily focuses on the mechanical removal of dental plaque through tooth brushing and flossing. While these methods are effective in reducing gingival inflammation and bacterial load, they often fail to completely eliminate plaque, especially in interdental areas. Probiotics have shown promising potential as adjunctive therapy in the management of periodontal disease by restoring microbial balance, modulating host inflammatory responses, and reducing the levels of pathogenic bacteria.
The objective of this study is to evaluate the prevention and supportive therapeutic efficacy of a oral-spray Bacillus spore probiotics (LiveSpo Smile CARE) in alleviating typical symptoms of periodontal disease. Investigators will assess safety, clinical symptom improvement, and reduction in the oral pathogenic bacterial load in elderly participants after 7, 14, 28, and 42 days of using LiveSpo Smile CARE.
This will be a randomized, blind, placebo-controlled clinical trial. The trial will have 12-18 months of duration. Participants will be required to provide demographic data, oral health history, and information regarding prior antibiotic use. Upon providing written informed consent and meeting eligibility criteria, 90 participants will be enrolled and randomly assigned to two groups (n = 45 per group). The placebo group will receive a 0.9% NaCl physiological saline spray, while the intervention group ("Smile Care") will receive the oral-spray probiotics, LiveSpo Smile CARE.
-Primary outcomes
Changes in clinical symptoms (For example: Debris Index-Simplified [DI-S], Gingival Index [GI], Bleeding on Probing [BOP], Gingival Recession [REC], Probing Depth [PD], Clinical Attachment Level [CAL], Halitosis...) at day 28 vs. day 0.
-Secondary outcomes
Changes in cytokine levels (ELISA) and semi-quantification of bacterial pathogens (real-time PCR) in gingival crevicular fluid samples, collected at day 28 compared with day 0.
- Expected outcomes Change in the oral microbiome composition at day 28 vs. day 0.
Presence of Bacillus subtilis ANA48 and Bacillus clausii ANA39 in gingival fluid will be assessed by real-time PCR at follow-up visits (days 7, 14, 28 and 42) compared with day 0, to confirm product use compliance.
Statistical analysis will be conducted using the chi-square test or Fisher's exact test for categorical variables, and t-test, Mann-Whitney test, or Wilcoxon test for continuous variables, depending on data distribution.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's planned enrollment of 90 is above the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Anabio R&D is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
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Exclusion Criteria
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.
Drug: oral-spray 0.9% NaCl physiological saline solution
Participants assigned to the experimental group will receive LiveSpo® Smile CARE (20 mL), formulated as an oral-spray probiotics containing ≥ 1 × 10⁹ CFU/ 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.
Combination Product: LiveSpo Smile CARE
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.
Also known as: Registration number: VD-32723-19
LiveSpo Smile CARE is manufactured as a Class-A medical device (product declaration 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 billion CFU/ (20 billion CFU/20 mL suspension)
Oral health indicators
Percentage of teeth classified according to a grading scale (good, moderate, and severe) for the following parameters: Simple Debris Index (DI-S), Gingival Index (GI), Bleeding on Probing (BOP), and Halitosis (score 1-4) is assessed at various time points relative to day 0.
Time frame: Days 0, 7, 14, 28 and 42
Periodontal parameters
Periodontal parameters are assessed for the following: Recession of the Gingival Margin (REC, mm), Probing Depth (PD, mm), and Clinical Attachment Loss (CAL, mm). These parameters are assessed at various time points relative to day 0.
Time frame: Days 0, 7, 14, 28 and 42
Changes in pro-inflammatory cytokine and IgA levels in gingival crevicular fluid samples at days 0, 7, 14, 28, and 42
Changes in pro-inflammatory cytokine levels (e.g. IL-6, IL-8, TNF-alpha...) in gingival crevicular fluid samples.
Time frame: Days 0, 7, 14, 28, and 42
Changes in the concentration of pathogenic bacteria around the teeth
Changes in the levels of pathogenic bacteria (P. gingivalis, A. actinomycetemcomitans, and S. mutans) in swab samples taken around the teeth will be evaluated at various time points relative to day 0.
Time frame: Days 0, 7, 14, 28, and 42
Changes in the oral microbiome at day 28 compared to day 0
Changes in diversity indices and relative taxonomy compositions (16S rRNA NGS) of gingival crevicular fluid samples at day 28 compared to day 0.
Time frame: Days 0 and 28
Plan to share: Yes — Data or samples share that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Sap, Icf, Csr
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