Oral-Spray Bacillus Spore Probiotics for Periodontal Disease Prevention and Supprotive Treatment in the Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorAnabio R&D
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
oral-spray 0.9% NaCl physiological saline solution
DrugThe oral-spray 0.9% NaCl physiological saline solution is prepared by extracting 20 mL from a 500 mL polypropylene bottle of 0.9% NaCl intravenous infusion (B. Braun, Germany; product declaration No. VD-32732-19). The solution is contained in an opaque plastic spray bottle identical to that used for the administration of Smile Care.
LiveSpo Smile CARE
Combination productLiveSpo Smile CARE is manufactured as a Class-A medical device (product declaration 250002196/PCBA-HN) in compliance with manufacturing standards approved by the Hanoi Department of Health, Ministry of Health. The product is formulated as a 0.9% NaCl physiological saline solution plus Bacillus subtilis ANA48 and Bacillus clausii ANA39 at total concentration of ≥ 1 billion CFU/ (20 billion CFU/20 mL suspension)
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Smile CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Oral health indicators
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 at various time points relative to day 0.
Time frame
Days 0, 7, 14, 28 and 422
Periodontal parameters
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 at various time points relative to day 0.
Time frame
Days 0, 7, 14, 28 and 42Secondary outcomes
1
Changes in pro-inflammatory cytokine and IgA levels in gingival crevicular fluid samples at days 0, 7, 14, 28, and 42
Changes in pro-inflammatory cytokine levels (e.g. IL-6, IL-8, TNF-alpha...) in gingival crevicular fluid samples.
Time frame
Days 0, 7, 14, 28, and 422
Changes in the concentration of pathogenic bacteria around the teeth
Changes in the levels of pathogenic bacteria (P. gingivalis, A. actinomycetemcomitans, and S. mutans) in swab samples taken around the teeth will be evaluated at various time points relative to day 0.
Time frame
Days 0, 7, 14, 28, and 42Other outcomes
1
Changes in the oral microbiome at day 28 compared to day 0
Changes in diversity indices and relative taxonomy compositions (16S rRNA NGS) of gingival crevicular fluid samples at day 28 compared to day 0.
Time frame
Days 0 and 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Anabio R&D
Lead sponsor
Hanoi Medical University
Collaborator
Source ClinicalTrials.gov