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临床试验/NCT07835477
NCT07835477已完成不适用

TBC1D15-Rab7-Fis1 Dysregulated in Periodontal Disease

Inonu University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Mean RAB7 protein level in gingival crevicular fluid

研究概览

简要总结

This study will look at certain proteins in the fluid found around the gums (called gingival crevicular fluid, or GCF) of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease).

The proteins being studied, TBC1D15, Rab7, and Fis1, help control the health of mitochondria, which act like tiny "power plants" inside our cells. When mitochondria become damaged, the body normally breaks them down and recycles them through a process these proteins help control. It is not yet known how this process relates to gum disease.

Seventy-two healthy adults will take part in this study and will be grouped based on the health of their gums. A sample of gum fluid (GCF) will be collected from each participant and tested to measure the levels of these proteins.

Researchers want to find out whether the levels of these proteins change as gum disease becomes more severe. If levels differ between people with healthy gums and those with periodontitis, this may suggest that problems with mitochondrial health and cleanup play a role in how gum disease develops and gets worse.

This information may help researchers better understand the biological processes involved in gum disease and could eventually lead to new ways to detect or treat it earlier.

详细描述

This study will examine the levels of certain proteins in the gingival crevicular fluid (GCF) of individuals with healthy gingiva, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). The proteins to be studied, TBC1D15, Rab7, and Fis1, are known to play roles in mitochondrial fission and mitophagy, processes closely linked to cellular energy metabolism and cell health, but their role in periodontal disease is not well understood.

Seventy-two healthy adults will be grouped according to their periodontal health status, and GCF samples will be collected and analyzed from each participant. Researchers will measure the levels of these proteins and look for patterns linking them to the severity of gum disease.

The results are expected to show whether TBC1D15, Rab7, and Fis1 levels differ in individuals with periodontitis compared to those with healthy gingiva, suggesting that these proteins may contribute to the development and progression of periodontal disease through mitochondrial dysfunction and dysregulated mitophagy. This information may help researchers better understand the biological processes underlying periodontal disease and could eventually contribute to new approaches for its detection or treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion criteria for the Healthy Control group:
  • •presence of ≥ 20 teeth in the mouth-probing pocket depth (PPD) ≤ 3 mm
  • •the percentage of bleeding sites for the whole mouth < 10%, on radiographic examination
  • •a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
  • •Inclusion criteria for the Gingivitis group:
  • •presence of ≥ 20 teeth in the mouth
  • •PPD ≤ 3 mm,
  • •% of bleeding sites for the whole mouth ≥ 10%,
  • •on radiographic examination, a distance of ≤ 3 mm between the cemento-enamel junction and the alveolar bone crest in 95% of all teeth.
  • •Inclusion criteria for the Stage 3 Periodontitis group:
  • •presence of ≥ 15 teeth in the mouth
  • •more than 30% of teeth affected by periodontal disease
  • •affected teeth exhibiting probing depths of 6 mm or more
  • •clinical attachment loss (CAL) of ≥ 5 mm,
  • •vertical bone loss of 3 mm or more
  • •class 2 or 3 furcation involvement
  • •radiographic evidence of alveolar bone loss extending to the middle third and beyond (33%) in the relevant teeth

排除标准

  • •presence of any systemic disease
  • •regular use of any medication
  • •pregnancy or lactation
  • •periodontal treatment within the last 6 months
  • •antibiotic use within the last 6 months
  • •the presence of prosthetic restorations on the teeth to be sampled

研究组 & 干预措施

periodontally healthy

periodontally healthy participants

gingivitis

patients with gingivitis

periodontitis

patients with periodontitis

结局指标

主要结局

Mean RAB7 protein level in gingival crevicular fluid

时间窗: At the time of GCF sampling

RAB7 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.

Mean Fis1 protein level in gingival crevicular fluid

时间窗: At the time of GCF sampling

Fis1 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.

Mean TBC1D15 protein level in gingival crevicular fluid

时间窗: At the time of GCF sampling

TBC1D15 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.

Mean NLRP3 protein level in gingival crevicular fluid

时间窗: At the time of GCF sampling

NLRP3 protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.

Mean IL-1β protein level in gingival crevicular fluid

时间窗: At the time of GCF sampling

IL-1β protein concentration in gingival crevicular fluid (GCF) samples of study participants, measured by ELISA.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kubra Aral

associate professor

Inonu University

研究点 (1)

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