JPRN-jRCTs031220449进行中（未招募）Unknown
A study on the effect of continuous intake of food containing Lactiplantibacillus pentosus ONRICb0240 on gingival inflammation index in patients with gingivitis
Iwata Takanori0 个研究点目标入组 130 人开始时间: 2022年11月17日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 69age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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