A new clinical trial introduces innovative oral-spray Bacillus spore probiotics aimed at improving periodontal disease prevention and treatment among elderly patients. Sponsored by Anabio R&D and Hanoi Medical University, this study focuses on enhancing oral health using LiveSpo Smile CARE and 0.9% NaCl saline as interventions.
In this article:
- What changed?
- What does the study target?
- What are the intervention details?
- Why this matters?
- FAQ
- Conclusion
- Disclaimer
- Full announcement
What changed?
The study, listed on ClinicalTrials.gov (not yet recruiting as of December 2025), aims to explore the potential benefits of oral-spray probiotics containing Bacillus spores for managing periodontal diseases. Elderly individuals remain disproportionately affected by oral and periodontal health issues, often complicating ongoing health management.
As the trial progresses, insights from its findings could further establish evidence on novel oral care approaches reliant on probiotic-based solutions.
What does the study target?
This clinical research addresses periodontal disease and other oral diseases commonly observed in elderly populations. Periodontal disease, characterized by inflammation around the teeth and progressive loss of supporting tissue, is a prevalent concern globally.
Researchers aim to evaluate LiveSpo Smile CARE, a combination product leveraging Bacillus spores, alongside a physiological saline solution to test efficacy in prevention and supportive treatment protocols.
What are the intervention details?
Two interventions will be administered in this study:
- 0.9% NaCl saline solution: Used orally as a physiological saline spray, this acts as the control measure in the study.
- LiveSpo Smile CARE: A proprietary Bacillus spore-based combination product designed to improve oral health through probiotic activity. Spore probiotics naturally support microbial balance in the oral microbiome.
Regulated clinical trials like this ensure safety, performance, and efficacy, providing actionable insight into medical device innovations.
Why this matters?
Improving oral health in the elderly goes beyond comfort—it mitigates risks associated with systemic diseases aggravated by chronic periodontal issues. If successful, the interventions may redefine preventive measures for oral disease management, contributing to better clinical guidelines.
Such data-driven approaches also align with regulatory focuses on patient-centric solutions emphasizing safety and performance.
FAQ
- 1. Who can participate?
Elderly patients diagnosed with periodontal or oral diseases may qualify once the trial begins recruitment. - 2. What is unique about Bacillus spore probiotics?
Bacillus spores are resilient probiotics capable of surviving harsh conditions, making them effective for oral microbiome modulation. - 3. How does this study improve oral healthcare?
It focuses on integrating probiotics into dental treatment, potentially reducing systemic risks associated with oral disease.
Conclusion
This upcoming trial promises to deliver critical insights into novel probiotic use for periodontal health, aligning well with the needs of elderly populations. For clinical, regulatory, and quality teams, tracking the study progress may unveil new avenues for intervention adherence and safety documentation best practices.
Disclaimer
The information presented here is intended exclusively for professionals in clinical, regulatory, and medical sectors. It does not constitute legal or medical advice. Always refer to official documentation for compliance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07258303?term=medical+device