NIPH Clinical Trials Search

Novel LactoBacillus L. crispatus YIT 12319 (LcY) Efficacy Assessed upon Combination with biofilm removal by professional mechanical tooth cleaning in Healthy volunteers; single center, double-blinded, randomized-controlled trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Healthy volunteer or patients with mild periodontitis
Date of first enrollment	30/10/2025
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	Intervention 1: PMTC (Professional Mechanical Teeth Cleaning) All subjects actually enrolled in the study will undergo a pre-PMTC examination at observation point 0 week (baseline), followed by PMTC. Intervention 2: Intake of study food Group A: Intake of food containing novel lactobacilli (L. crispatus YIT 12319 (LcY)) for 8 weeks. Group B: Intake of a placebo food without LcY for 8 weeks.

Outcome(s)

Primary Outcome

Bacterial content (measurement value) of periodontopathogenic bacteria (P. gingivalis) in stimulated saliva at observation point week 8 (real-time PCR method)

Secondary Outcome

Measurement at each observation point, change from baseline to each observation point, and change from observation point week 8 to week 12 for the following items; 1. Bacterial content of periodontopathogenic bacteria (P. gingivalis, F. nucleatum, P. intermedia, T. Periodontopathogenic bacteria (P. gingivalis, F. nucleatum, P. intermedia, T. denticola, T. forsythia, T. denticola) in stimulated saliva (real-time PCR method) (excluding the primary endpoint) 2. Bacterial content of periodontopathogenic bacteria (P. gingivalis and F. nucleatum) in stimulated saliva (PMA-qPCR method) 3. Bacterial content of other bacteria in stimulated saliva (total content of oral bacteria) 4. Bacterial content of cariogenic bacteria (mutans and lactobacillus counts) in stimulated saliva 5. stimulated saliva properties (pH, volume) 6. amount of calprotectin in stimulated saliva 7. amount of vascular endothelial growth factor (VEGF) and epidermal growth factor (hEGF) in stimulated saliva 8. clinical indices (gingivitis index (GI), plaque index (PI); and Bleeding on Probing (BOP), Probing Depth (PD), Clinical Attachment Level (CAL), Tongue Score) 9. Distribution and bacterial content of P. gingivalis by lineage type in stimulated saliva 10. Oral Microflora, measured by Miseq 11. Survey about subjective symptoms and bodily sensation

Key inclusion & exclusion criteria

Age minimum	>= 30age old
Age maximum	<= 65age old
Gender	Both
Include criteria	Subjects who meet all of the following criteria can be included in this study: <Inclusion criteria for provisional registration> 1. Male and female aged 30 years or older and 65 years or younger 2. Subjects who usually eat 3 times a day 3. Subjects who do not have the habit of brushing their tongue when brushing their teeth (those who can stop brushing their tongue during the study period can be included in this study) 4. Subjects who receive a thorough explanation of the study and given their consent to participate in this study by written form <Inclusion criteria for actual registration> 5. Subjects in whom at least 4 of the labial and buccal surfaces of 6 following teeth can be measured; 16 (maxillary right first molar, FDI tooth code; same below), 21 (maxillary left central incisor), 24 (maxillary left first premolar), 36 (mandibular left first molar), 41 (mandibular right central incisor), and 44 (mandibular right first premolar), or subjects with FDI tooth codes 17, 15, 11, 22, 25, 37, 35, 31, 42, and 45 present as replacements for the aforementioned 6 representative teeth. 6. Subjects with 20 or more teeth 7. Subjects with P. gingivalis detected in both screening tests 1 and 2
Exclude criteria	Subjects who fall into any of the following criteria who fall into any of the following criteria are excluded from participating in the study; <Exclusion criteria for provisional registration> 1. Subjects with current smoke 2. Patients with diabetes, chronic kidney disease, gastrointestinal disorders, lung diseases, malignant tumors, etc. and who are taking medication 3. Subjects who use mouthwash or other products that inhibit periodontopathogenic bacteria on a daily basis (those who can stop the use from the screening test till the study completion can be included in this study) 4. Subjects who are taking or have taken antibiotics or antibacterial agents within 1 month prior to the screening test 5. Subjects who are using drugs, supplements or healthy foods that may affect periodontopathogenic bacteria and oral examination (those who can stop the use from the screening test till the study completion can be included in this study) 6. Subjects who have been aware of any health problems due to the consumption of dairy products 7. Subjects who are pregnant, lactating, may be pregnant or plan to become pregnant 8. Subjects who are participating or intend to participate in clinical studies involving the consumption of other foods, the use of drugs, or the application of cosmetics or drugs 9. Subjects who require a legal representative 10. Subjects who are judged by investigators to be inappropriate to participate in this study <Exclusion criteria for actual registration> 11. Subjects with stimulated saliva volume of less than 3.0 mL at either screening test 1 or 2 12. Subjects with caries (C3 or higher) or periodontal pocket greater than 6 mm at the screening tests