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New treatment option for Dental Caries
Official title Oral-Spray Bacillus Spore Probiotic in Preventing and Supporting Treatment of Dental Caries in Children
ClinicalTrials.gov ID: NCT07241052
What this study is testing
What is oral-spray 0.9% NaCl physiological saline solution?
oral-spray 0.9% NaCl physiological saline solution is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for dental caries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 10. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Written informed consent obtained from a parent or legal guardian.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Hà Nội, Sơn Tây, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 10 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hà Nội, Sơn Tây, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.