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A study on the effect of continuous intake of food containing Lactiplantibacillus pentosus ONRICb0240 on gingival inflammation index in patients with gingivitis

Study on gingivitis improvement effect of L. pentosus

134

Screening1: 391 subjects Screening2: 213 subjects Randomized: 136 subjects Sex [n(%)] Male: 52 subjects (38.8%) Female: 82 subjects (61.2%) Age [mean (standard deviation, SD)] Test food group: 43.8 (12.5) years old Control food group: 45.9 (11.5) years old

First subject first visit: 2022/12/14 Last subject first visit: 2023/5/15 Final follow-up: 2023/8/7 <Subject Disposition> Signed informed consent: 395 Discontinued after randomized: 2

No relevant events, no illnesses reported.

Bleeding on probing (BOP), the primary endpoint, decreased significantly over time after intake in both the test and control food groups compared to before intake (p<0.001), but changes after intake were not significantly different between the test and control food groups (p=0.082).In a sensitivity analysis that excluded study subjects who took drugs that affect gingival inflammation (e.g., anti-inflammatory analgesics), there was a significant difference between the test food group and the control food group in changes in BOP (p=0.048). There was also a significant difference between the test food group and the control food group in BOP that included #8 (wisdom teeth) (p=0.041). The secondary endpoints of PPD (Probing pocket depth), CAL (Clinical attachment level), GI (Gingival index), and PCR (Plaque control record) generally decreased significantly over time after intake compared to before intake. However, there were no significant differences between the test food group and the control food group in these changes after intake. The main adverse events that occurred were allergic reactions and headache. There were no statistically significant differences between the test and control food groups in the percentage of subjects reporting any one adverse event occurring from the start of consumption of the study foods to the day after the end of consumption.

Continuous consumption of gummy-like foods containing Lactiplantibacillus pentosus ONRICb0240 was suggested to improve gingival inflammation indices in patients with gingivitis compared to gummy-like foods without ONRICb0240, and was found to be safe as well.

Mar. 31, 2024

No

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https://jrct.mhlw.go.jp/latest-detail/jRCTs031220449

Iwata Takanori

Tokyo Medical and Dental University

1-5-45, Yushima, Bunkyo-ku, Tokyo

iwata.peri@tmd.ac.jp

Maekawa Shogo

Tokyo Medical and Dental University

1-5-45, Yushima, Bunkyo-ku, Tokyo

+81-3-5803-5011

maekawa.peri@tmd.ac.jp

Complete

Dec. 14, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.

Both

Gingivitis

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.

Gingivitis, Periodontal Disease

Food containing lactic acid bacteria

074

Bleeding on Probing (BOP)

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

+81-3-5803-4575

Nov. 08, 2022

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