Study on gingivitis improvement effect of L. pentosus

JRCT ID: jRCTs031220449

Registered date:17/11/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Gingivitis
• Date of first enrollment: 14/12/2022
• Target sample size: 130
• Study type: Interventional
• Intervention(s): Gummy-like food containing lactic acid bacterium ONRICb0240 or placebo (gummy-like food not containing lactic acid bacterium ONRICb0240) was ingested twice a day for 6 consecutive weeks.

Outcome(s)

• Primary Outcome: Bleeding on Probing (BOP)

Secondary Outcome

Probing pocket depth (PPD)
Clinical attachment level (CAL)
Gingival index (GI)
Plaque control record (PCR)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 69age old
• Gender: Both

Include criteria

1)Subjects aged 20-69 years at the time of informed consent
2)Subjects who have more than 20 remaining teeth
3)Subjects who have one or more of the following symptoms of gingivitis (periodontal disease self-check format:8020 Promotion Foundation)
A)Subjects who have blood on their toothbrush or blood in the rinse water after brushing their teeth.
B)Subjects whose gums between teeth are congested and swollen instead of sharp triangles.
C)Subjects who have teeth that are a little loose when touched with a finger.
D)Subjects who have had pus from the gums.
4)Subjects with a BOP of 5% or more and less than 40% in the periodontal tissue examination during screening.
5)Subjects who have no serious health problems, are independent in their daily lives and have no trouble visiting the hospital for research purposes.
6)Subjects who have given written informed consent for research participation.

Exclude criteria

1)Subjects whose unstimulated salivary secretion is less than 0.5 g/10 minutes in the screening test.
2)Pregnant women, women who may become pregnant, and women who wish to become pregnant during the study period.
3)Lactating women.
4)Subjects who have a history of hypersensitivity to gelatin and sugar alcohols.
5)Subjects who may require dental treatment (including orthodontics) during the study participation period.
6)Subjects who have undergone tooth extraction other than wisdom tooth extraction or convenience tooth extraction in orthodontic treatment within 12 months.
7)Those who have taken antibacterial drugs (antibiotics / antibiotics) within 3 months. Those who regularly use calcium channel blockers, antiepileptic drugs, and immunosuppressants.
8)Subjects who may use antihistamines during the study period due to hay fever or allergies.
9)Subjects who have smoked within 1 year.
10)Subjects who underwent dental treatment or cleaning at a dental clinic within 6 months.
11)Subjects who cannot follow the restrictions stipulated in this research.
12)Subjects who have participated in other clinical research and have not passed more than 1 month since their completion.
13)In addition, Subjects who are judged inappropriate for participation in this study by the investigator.
14)Subjects whose unstimulated salivary secretion is less than 0.5 g/10 minutes in the screening test Pregnant women, women who may become pregnant, and women who wish to become pregnant during the study period.

Related Information

• Primary Sponsor: Iwata Takanori
• Secondary Sponsor: Otsuka Pharmaceutical Co., Ltd.