Hanoi Medical University

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

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:
* Sample Size: 90 participants
* Study Location: an elderly care center in Hanoi, Vietnam
Intervention Description: A total of 90 eligible participants will be randomly assigned to two groups (n = 45 per group).
* The Placebo Group will receive 0.9% NaCl physiological saline, spray twice daily (afternoon and evening), with two sprays per application at three sites (both dental arches and the front teeth), totaling six sprays per use, for four consecutive weeks.
* The 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), administered with the same dosage and frequency as the placebo 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.

The objective of this clinical trial is to investigate whether the combination of pelvic floor muscle training (PFMT) and topical estrogen is more effective in treating stress urinary incontinence (SUI) in postmenopausal women compared to topical estrogen alone. The trial will also analyze factors related to the outcomes of the combined therapy. The key questions this trial aims to answer are:
* Does the combination of PFMT and topical estrogen improve symptoms of stress urinary incontinence in postmenopausal women better than topical estrogen alone?
* Which factors are associated with the effectiveness of the combined therapy?
Researchers will compare the group receiving the combined therapy (pelvic floor muscle training plus topical estrogen) with the group receiving topical estrogen alone to determine whether adding PFMT to estrogen therapy provides additional treatment benefits for SUI in postmenopausal women.
Participants will:
- Be randomly assigned to one of two groups:
Group 1: Undergo a pelvic floor muscle training (PFMT) program combined with topical estrogen therapy (e.g., vaginal cream/application,...).
Group 2: Receive topical estrogen therapy alone (e.g., vaginal cream/application,...).
* Follow the assigned intervention protocol for a specified duration.
* Attend regular clinic visits for clinical examinations, assessment of incontinence severity, and related measurements.
* Monitor and record their incontinence symptoms and the frequency of urine leakage during daily activities.