Bacillus spore oral spray to prevent and support treatment of gum disease in older adults
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
This test tries a Bacillus spore oral spray to see if it cuts harmful mouth bacteria and improves gum health in people aged 35 and older with periodontal disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Anabio R&D Industry-sponsored |
| Locations | 1 site (Hanoi, Hanoi) |
| Trial ID | NCT07258303 on ClinicalTrials.gov |
What this trial studies
This interventional study gives an oral-spray probiotic containing Bacillus subtilis ANA48 and Bacillus clausii ANA39 or a saline control directly into the mouth of adult participants with gingivitis or periodontitis. Participants must have at least 10 natural teeth and be in stable general health. Outcomes include safety, changes in pathogenic bacterial density in the oral biofilm, and clinical signs of periodontal inflammation. The study is conducted at a senior care center in Hanoi with oversight from local academic collaborators.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 or older with clinical gingivitis or periodontitis, at least 10 natural teeth, stable general health, and the ability to provide informed consent.
Not a fit: People with unstable systemic or acute oral disease, those currently receiving specialized periodontal treatment, or those already using other periodontal therapies are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the spray could reduce pathogenic oral bacteria and inflammation, helping to prevent or better control periodontal disease in older adults.
How similar studies have performed: Other oral probiotic studies have shown modest benefits as an adjunct for periodontal disease, but Bacillus spore-based oral sprays are a relatively new and less-studied approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients aged 35 years and older. * Patients diagnosed with periodontal disease based on clinical examination, including gingivitis and periodontitis. * Patients presenting with at least 10 natural teeth in the dental arch. * Patients with stable general health status and able to comply with study procedures. * Patients (or their legal guardians) who provide written informed consent and voluntarily agree to participate in the study. Exclusion Criteria * Patients with unstable general health, acute systemic or oral diseases, or malignant conditions that may interfere with participation. * Patients who are currently receiving treatment for periodontal disease at specialized dental facilities. * Patients currently using any therapeutic or adjunctive products for the management of periodontal disease.
Where this trial is running
Hanoi, Hanoi
- Tuyet Thai Senior Care Center — Hanoi, Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Thu TH Nguyen, Assoc. Prof. — Hanoi Medical University
- Study coordinator: Nga TT Pham, PhD. MD
- Email: Tuyetnga@hmu.edu.vn
- Phone: (84) 0983042975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.