跳至主要内容
临床试验/CTRI/2024/07/070133
CTRI/2024/07/070133尚未招募2 期

Comparative study of the efficacy of swabbed and spit saliva for detection of red complex bacteria and salivary inflammatory markers in periodontitis

未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月17日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Detection of red complex bacteria in swabbed and spit saliva at 4 degree Celsius and room temperature

研究概览

简要总结

To compare the efficacy of swabbed and spit saliva samples at 4°C and room temperature for the detection of red complex bacteria (Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola) and salivary inflammatory markers (IL6, TNF-α, NF-κB) in individuals diagnosed with periodontitis. Swabbed saliva will be collected by keeping the swab in the lingual vestibule, below the tongue, for 20 s. Spit saliva will be collected by asking the participant to expectorate into a sterile container. Saliva samples will be processed for the detection of red complex bacteria (P. gingivalis, T. forsythia, and T. denticola) & salivary inflammatory markers (IL6, TNF-α, NF-κB) using Multiplex RT-PCR test kits.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Participants aged 18 years and older.
  • Subjects diagnosed with periodontitis as per the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Subjects who have not undergone any periodontal therapy in the past six months.

排除标准

  • Participants with systemic diseases that could affect periodontal health (e.g., uncontrolled diabetes).
  • Participants currently undergoing periodontal treatment.
  • History of antibiotic use within the past three months.

结局指标

主要结局

Detection of red complex bacteria in swabbed and spit saliva at 4 degree Celsius and room temperature

时间窗: 3 months

次要结局

  • To detect whether the swabbed or spit saliva is better for the detection of red complex bacteria and also to identify the suitable temperature.(3 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Majo Ambooken

Mar Baselios Dental College

研究点 (1)

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