Dental CariesNCT07241052
Oral-Spray Bacillus Spore Probiotic in Preventing and Supporting Treatment of Dental Caries in Children
A study testing oral-spray 0.9% NaCl physiological saline solution and Smile Care in people with Dental Caries, run by Anabio R&D at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- oral-spray 0.9% NaCl physiological saline solution and Smile Care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Mar 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Thanh My Primary School
Hà Nội, Sơn Tây, 100000
Oanh T Dao, 02433838041 ext. 0987899089, c1thanhmy-st@hanoiedu.vn
About this study
Official title: Evaluating Safety and Efficacy of Oral-Spray Bacillus Probiotic (LiveSpo® Smile CARE) in the Prevention and Adjunctive Treatment of Dental Caries in Children
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.
Read more
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
Read the detailed description
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.
- Secondary Outcomes:
Changes in cytokine levels (ELISA) and semi-quantification of bacterial pathogens (real-time PCR) at months 1 and 3 compared with day 0.
- Exploratory Outcomes: Detection of B. subtilis ANA48 and B. clausii ANA39 in soft dentin and saliva samples (months 1, 2, and 3) of the Smile Care group, but not in the Placebo group.
Comparative analysis of oral microbiota diversity and bacterial density at month 1 between the placebo and Smile Care groups, using a reference group of at least 10 healthy children without dental caries.
Statistical Analysis:
Categorical variables will be analyzed using chi-square or Fisher's exact tests, while continuous variables will be assessed using t-tests, Mann-Whitney U, or Wilcoxon signed-rank tests depending on distribution.
- Conditions
- Dental Caries
- Being tested
- oral-spray 0.9% NaCl physiological saline solution, Smile Care
- Keywords
- Dental caries, Children, probiotics, Oral health, Oral-spray, Bacillus spores
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral-spray 0.9% NaCl physiological saline solutionDrug
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.
Smile CareCombination product
LiveSpo® 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: oral-spray 0.9% NaCl physiological saline solution |
| Smile Care | Experimental | 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. Receives: Combination Product: Smile Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0, and months 1, 2, 3
Secondary outcomes (2)
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).
Measured: Day 0 and months 1, 2, 3
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).
Measured: Day 0 and months 1, 2, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start5 Mar 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, randomized, and controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anabio R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hanoi Medical University
- Responsible party
- Sponsor
- Investigators
- Nga TT Pham, PhD. MD, Study chair, Hanoi Medical UniversityThu TH Nguyen, Assoc. Prof., Principal investigator, Hanoi Medical UniversityAnh TV Nguyen, Assoc. Prof., Principal investigator, Spobio Research Center, Anabio R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241052
- Sponsor's protocol ID
- TNLS.2025.S
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kim H, Han CY, Eun SH, Kim MG, Im AR, Lee B. Inhibitory effects of Bacillus velezensis ID-A01 supernatant against Streptococcus mutans. BMC Microbiol. 2023 Nov 24;23(1):362. doi: 10.1186/s12866-023-03114-2.
PubMed 37996837Jindal G, Pandey RK, Agarwal J, Singh M. A comparative evaluation of probiotics on salivary mutans streptococci counts in Indian children. Eur Arch Paediatr Dent. 2011 Aug;12(4):211-5. doi: 10.1007/BF03262809.
PubMed 21806906Aleti G, Sessitsch A, Brader G. Genome mining: Prediction of lipopeptides and polyketides from Bacillus and related Firmicutes. Comput Struct Biotechnol J. 2015 Mar 24;13:192-203. doi: 10.1016/j.csbj.2015.03.003. eCollection 2015.
PubMed 25893081Hajishengallis E, Parsaei Y, Klein MI, Koo H. Advances in the microbial etiology and pathogenesis of early childhood caries. Mol Oral Microbiol. 2017 Feb;32(1):24-34. doi: 10.1111/omi.12152. Epub 2016 Feb 4.
PubMed 26714612Bustamante M, Oomah BD, Mosi-Roa Y, Rubilar M, Burgos-Diaz C. Probiotics as an Adjunct Therapy for the Treatment of Halitosis, Dental Caries and Periodontitis. Probiotics Antimicrob Proteins. 2020 Jun;12(2):325-334. doi: 10.1007/s12602-019-9521-4.
PubMed 30729452Simon-Soro A, Mira A. Solving the etiology of dental caries. Trends Microbiol. 2015 Feb;23(2):76-82. doi: 10.1016/j.tim.2014.10.010. Epub 2014 Nov 27.
PubMed 25435135Lu Y, Lin Y, Li M, He J. Roles of Streptococcus mutans-Candida albicans interaction in early childhood caries: a literature review. Front Cell Infect Microbiol. 2023 May 16;13:1151532. doi: 10.3389/fcimb.2023.1151532. eCollection 2023.
PubMed 37260705Takahashi N, Nyvad B. The role of bacteria in the caries process: ecological perspectives. J Dent Res. 2011 Mar;90(3):294-303. doi: 10.1177/0022034510379602. Epub 2010 Oct 5.
PubMed 20924061Sampaio-Maia B, Caldas IM, Pereira ML, Perez-Mongiovi D, Araujo R. The Oral Microbiome in Health and Its Implication in Oral and Systemic Diseases. Adv Appl Microbiol. 2016;97:171-210. doi: 10.1016/bs.aambs.2016.08.002. Epub 2016 Sep 21.
PubMed 27926431
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety and Efficacy of Oral-Spray Bacillus Probiotic (LiveSpo® Smile CARE) in the Prevention and Adjunctive Treatment of Dental Caries in Children
- ClinicalTrials.gov ID
- NCT07241052
- Acronym / sponsor ID
- TNLS.2025.S
- Conditions
- Dental Caries
- Keywords
- Dental caries, Children, probiotics, Oral health, Oral-spray, Bacillus spores
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Anabio R&DIndustry (pharma, biotech, devices)
- Collaborators
- Hanoi Medical University
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
- Secondary Outcomes:
Changes in cytokine levels (ELISA) and semi-quantification of bacterial pathogens (real-time PCR) at months 1 and 3 compared with day 0.
- Exploratory Outcomes: Detection of B. subtilis ANA48 and B. clausii ANA39 in soft dentin and saliva samples (months 1, 2, and 3) of the Smile Care group, but not in the Placebo group.
Comparative analysis of oral microbiota diversity and bacterial density at month 1 between the placebo and Smile Care groups, using a reference group of at least 10 healthy children without dental caries.
Statistical Analysis:
Categorical variables will be analyzed using chi-square or Fisher's exact tests, while continuous variables will be assessed using t-tests, Mann-Whitney U, or Wilcoxon signed-rank tests depending on distribution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Blinded, randomized, and controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: oral-spray 0.9% NaCl physiological saline solutionParticipants 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. |
| Smile Care | Experimental | Combination Product: Smile CareChildren 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. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral-spray 0.9% NaCl physiological saline solutionThe 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. | Drug | Placebo |
| Smile CareLiveSpo® 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). | Combination product | Smile Care |
Primary outcome
Decayed Teeth Index
Time frame: 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.
2 secondary outcomes
Changes in the concentration of pathogenic bacteria in deep carious dentin and saliva samples
Time frame: Day 0 and months 1, 2, 3
Changes in Inflammatory Cytokines and IgA levels in deep carious dentin and saliva samples
Time frame: Day 0 and months 1, 2, 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Results publication: PubMed 37996837Kim H, Han CY, Eun SH, Kim MG, Im AR, Lee B. Inhibitory effects of Bacillus velezensis ID-A01 supernatant against Streptococcus mutans. BMC Microbiol. 2023 Nov 24;23(1):362. doi: 10.1186/s12866-023-03114-2.
- Results publication: PubMed 21806906Jindal G, Pandey RK, Agarwal J, Singh M. A comparative evaluation of probiotics on salivary mutans streptococci counts in Indian children. Eur Arch Paediatr Dent. 2011 Aug;12(4):211-5. doi: 10.1007/BF03262809.
- Results publication: PubMed 25893081Aleti G, Sessitsch A, Brader G. Genome mining: Prediction of lipopeptides and polyketides from Bacillus and related Firmicutes. Comput Struct Biotechnol J. 2015 Mar 24;13:192-203. doi: 10.1016/j.csbj.2015.03.003. eCollection 2015.
- Results publication: PubMed 26714612Hajishengallis E, Parsaei Y, Klein MI, Koo H. Advances in the microbial etiology and pathogenesis of early childhood caries. Mol Oral Microbiol. 2017 Feb;32(1):24-34. doi: 10.1111/omi.12152. Epub 2016 Feb 4.
- Results publication: PubMed 30729452Bustamante M, Oomah BD, Mosi-Roa Y, Rubilar M, Burgos-Diaz C. Probiotics as an Adjunct Therapy for the Treatment of Halitosis, Dental Caries and Periodontitis. Probiotics Antimicrob Proteins. 2020 Jun;12(2):325-334. doi: 10.1007/s12602-019-9521-4.
- Results publication: PubMed 25435135Simon-Soro A, Mira A. Solving the etiology of dental caries. Trends Microbiol. 2015 Feb;23(2):76-82. doi: 10.1016/j.tim.2014.10.010. Epub 2014 Nov 27.
- Results publication: PubMed 37260705Lu Y, Lin Y, Li M, He J. Roles of Streptococcus mutans-Candida albicans interaction in early childhood caries: a literature review. Front Cell Infect Microbiol. 2023 May 16;13:1151532. doi: 10.3389/fcimb.2023.1151532. eCollection 2023.
- Results publication: PubMed 20924061Takahashi N, Nyvad B. The role of bacteria in the caries process: ecological perspectives. J Dent Res. 2011 Mar;90(3):294-303. doi: 10.1177/0022034510379602. Epub 2010 Oct 5.
- Results publication: PubMed 27926431Sampaio-Maia B, Caldas IM, Pereira ML, Perez-Mongiovi D, Araujo R. The Oral Microbiome in Health and Its Implication in Oral and Systemic Diseases. Adv Appl Microbiol. 2016;97:171-210. doi: 10.1016/bs.aambs.2016.08.002. Epub 2016 Sep 21.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nga TT Pham, PhD. MD study chair
Hanoi Medical University
Thu TH Nguyen, Assoc. Prof. principal investigator
Hanoi Medical University
Anh TV Nguyen, Assoc. Prof. principal investigator
Spobio Research Center, Anabio R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral-spray 0.9% NaCl physiological saline solution and Smile Care in people with Dental Caries, run by Anabio R&D at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nga TT Pham, PhD. MD ((84) 0983042975, Tuyetnga@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decayed Teeth Index (time frame: Day 0, and months 1, 2, 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07241052, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.