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临床试验/CTRI/2024/04/065213
CTRI/2024/04/065213尚未招募不适用

Assessment of Correlation of Red Complex Bacteria in Saliva and Gingival Crevicular Fluid(GCF) using Multiplex Real Time – Polymerase Chain Reaction(RT-PCR) In Subjects with Periodontitis.

Dr Sahin Sahalam Mollick Mollick1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1.To assess and find a correlation of the levels of red complex bacteria (Porphyromonas gingivalis,

研究概览

简要总结

Periodontitis is a chronic inflammation associated with dysbiotic subgingival biofilms , resulting in progressive and irreversible destruction of the tooth supporting tissues.Although it is not clear whether dysbiotic biofilms initiate the disease or is a consequence of the disease, it is well established that at diseased status the subgingival microbiota is enriched with gram-negative, proteolytic bacteria, while in healthy situation, the microbiota is mainly composed of gram-positive bacteria.Among microbial complexes, the first complex that has been related to disease is the orange complex consisting of anaerobic gram-negative species (Prevotella intermedia, Prevotella nigrescens, Prevotella micros, and Fusobacterium nucleatum) which on disease progression shifts toward red-complex bacteria consisting of Tannerella forsythia, Treponema denticola, and Porphyromonas gingivalis.The red complex bacteria play a critical role in the pathogenesis of periodontitis. These bacteria are found together in periodontal pocket, implicating that they work in synergistic manner leading to destruction of periodontal tissue. The prevalence of periodontitis in India is 51%, and studies related to diagnosis of different forms of Periopathogens are few in Indian published literature, hence its also necessary to further establish data regarding the same.Hence an attempt is being made to assess and correlate in both saliva and GCF the red complex bacteria Porphyromonas Gingivalis (Pg), Tannerella Forsythia (Tf) & Treponema Denticola (Td) using Multiplex RT-PCR using saliva and GCF samples in periodontitis patients.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group 20-60 yrs 2.Clinically diagnosed periodontitis (based on the 2017 world workshop classification of periodontal disease).
  • 3..Presence of at least two teeth with a probing depth of ≥5mm and clinical attachment loss of ≥3mm in each quadrant.(stage 2 ,stage 3 and stage 4 periodontitis, based on the 2017 world workshop classification of periodontal disease).

排除标准

  • 1.Subjects who have undergone Periodontal treatment since past 6 months.
  • Use of antibiotics & anti-inflammatory drugs since past 3 months.
  • Pregnant and lactating women.
  • Smokers and tobacco chewer.
  • Substances and any Drug abuse.

结局指标

主要结局

1.To assess and find a correlation of the levels of red complex bacteria (Porphyromonas gingivalis,

时间窗: Baseline

Tannerella forsythia &Treponema denticola) in the saliva and GCF samples in subjects with

时间窗: Baseline

periodontitis by multiplex RT-PCR technique.

时间窗: Baseline

次要结局

  • 2.To compare the level of red complex bacteria (Porphyromonas gingivalis, Tannerella forsythia, &Treponema denticola) in the saliva and GCF in patients with periodontitis by multiplex RT-PCR technique.(Baseline)

研究者

发起方
Dr Sahin Sahalam Mollick Mollick
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sahin Sahalam Mollick Mollick

Dayananda Sagar College of Dental Sciences

研究点 (1)

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