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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Anabio R&D
- 入组人数
- 90
- 主要终点
- Oral health indicators
研究概览
简要总结
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.
详细描述
According to the World Health Organization (WHO), severe oral disease is estimated to affect over 1 billion individuals worldwide. Studies have demonstrated that the prevalence of periodontal disease increases with age. In Vietnam, oral disease is a common oral health problem among the elderly, with a prevalence rate of approximately 91%. This includes 51.6% presenting with simple gingivitis and 39.4% with periodontitis. If left untreated, oral disease may lead to gingival inflammation, swelling, bleeding, and destruction of the supporting structures of the teeth, resulting in pain during mastication. In severe cases, it can cause tooth loss, systemic infections such as sepsis, and increase the long-term risk of systemic diseases including cardiovascular disease and diabetes.
Conventional treatment primarily focuses on the mechanical removal of dental plaque through tooth brushing and flossing. While these methods are effective in reducing gingival inflammation and bacterial load, they often fail to completely eliminate plaque, especially in interdental areas. Probiotics have shown promising potential as adjunctive therapy in the management of periodontal disease by restoring microbial balance, modulating host inflammatory responses, and reducing the levels of pathogenic bacteria.
The objective of this study is to evaluate the prevention and supportive therapeutic efficacy of a oral-spray Bacillus spore probiotics (LiveSpo Smile CARE) in alleviating typical symptoms of periodontal disease. Investigators will assess safety, clinical symptom improvement, and reduction in the oral pathogenic bacterial load in elderly participants after 7, 14, 28, and 42 days of using LiveSpo Smile CARE.
This will be a randomized, blind, placebo-controlled clinical trial. The trial will have 12-18 months of duration. Participants will be required to provide demographic data, oral health history, and information regarding prior antibiotic use. Upon providing written informed consent and meeting eligibility criteria, 90 participants will be enrolled and randomly assigned to two groups (n = 45 per group). The placebo group will receive a 0.9% NaCl physiological saline spray, while the intervention group ("Smile Care") will receive the oral-spray probiotics, LiveSpo Smile CARE.
-Primary outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
LiveSpo Smile CARE and placebo are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Smile CARE suspension are unrecognizable to investigators, trainers, caregivers, and paticipants due to opaque plastic container. Only the independent statistician is aware of the group codes.
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Participants allocated to the placebo group will receive a 0.9% NaCl physiological saline spray. The solution will be self-administered via spray, twice daily-once in the afternoon and once at night. At each administration, participants will apply two sprays to each side of the dental arch and two sprays to the incisor region, resulting in a total of six sprays per application. This regimen will be maintained consistently for a period of 4 weeks.
干预措施: oral-spray 0.9% NaCl physiological saline solution (Drug)
Smile Care
Participants assigned to the experimental group will receive LiveSpo® Smile CARE (20 mL), formulated as an oral-spray probiotics containing ≥ 1 × 10⁹ CFU/ mL of Bacillus subtilis and Bacillus clausii, of 0.9% sodium chloride solution. The suspension will be self-administered via oral spray twice daily once in the afternoon and once at night. At each administration, participants will apply two sprays to each side of the dental arch and two sprays to the incisor region, totaling six sprays per application. The intervention will be continued for a duration of 4 weeks.
干预措施: LiveSpo Smile CARE (Combination Product)
结局指标
主要结局
Oral health indicators
时间窗: Days 0, 7, 14, and 28
Percentage of teeth classified according to a grading scale (good, moderate, and severe) for the following parameters: Simple Debris Index (DI-S), Gingival Index (GI), Bleeding on Probing (BOP), and Halitosis (score 1-4) is assessed on day 28 compared with day 0; days 7 and 14 are collected as additional probing time points.
Periodontal parameters
时间窗: Days 0, 7, 14, and 28
Periodontal parameters are assessed for the following: Recession of the Gingival Margin (REC, mm), Probing Depth (PD, mm), and Clinical Attachment Loss (CAL, mm). These parameters are assessed on day 28 compared with day 0; additional probing time points are collected on days 7 and 14.
次要结局
- Changes in pro-inflammatory cytokine and IgA levels in gingival crevicular fluid samples at days 0, 7, 14, and 28(Days 0, 7, 14 and 28)
- Changes in the concentration of pathogenic bacteria around the teeth(Days 0, 7, 14, and 28)