跳至主要内容
临床试验/CTRI/2025/08/092224
CTRI/2025/08/092224尚未招募3 期

Evaluation of efficacy of interleukin 6 as a diagnostic marker to determine the severity of pulpal inflammation

Matta Navya1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
DIFFERENTIATE BETWEEN REVERSIBLE AND IRREVERSIBLE PULPITIS interms of interleukin 6 levels

研究概览

简要总结

Background: Pulpitis is an intricate inflammatory condition of the dental pulp, predominantly caused by microbial irritation. The clinical diagnosis of pulpitis categorized as either reversible or irreversible is typically based on subjective assessments, including patient reported symptoms and radiographic findings. However, these clinical evaluations may not always reflect the true histopathological status of the pulp. Accurate diagnosis is critical for the success of pulp therapy procedures. Emerging evidence suggests that inflammatory molecular biomarkers, particularly those involved in the pathogenesis of pulpitis, could serve as objective tools for assessing the extent of pulpal inflammation. Among these, interleukin-6 (IL-6) has shown promise as a diagnostic biomarker.

Aim: The objective of this study was to evaluate whether salivary IL-6 levels could be utilized as a supplementary diagnostic marker to determine the severity of pulp inflammation in cases of deep dental caries.

Methodology: The study included 10 paediatric patients, aged between 6 - 14 years, presenting with deep carious lesions. Based on clinical examination, radiographic examination five patients were diagnosed with reversible pulpitis (RP) and five with irreversible pulpitis (IP). Stimulated whole saliva samples were collected from the floor of the mouth. The concentration of IL-6 in these samples was quantified using the Chemiluminescent Immunoassay (CLIA) method. An independent sample t-test was conducted to analyse the statistical significance of differences in IL-6 levels between the two groups.

Results: IL-6 levels were found to be significantly elevated in the irreversible pulpitis group compared to the reversible pulpitis group. The mean IL-6 concentration was 8.18 pg/mL in the reversible pulpitis group and 29.52 pg/mL in the irreversible pulpitis group, indicating a marked distinction between the two inflammatory states.

Conclusion: The findings suggest that saliva may serve as a viable diagnostic medium for assessing pulpal inflammation, especially in the presence of deep carious lesions. Salivary IL-6 levels exhibited a strong discriminatory capacity between reversible and irreversible pulpitis.

KEY WORDS: Interleukin-6, salivary markers, reversible pulpitis, irreversible pulpitis, inflammatory mediators

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Children with dental caries, aged between 6–14 years, with no underlying systemic diseases were included.

排除标准

  • Recent febrile illness, systemic conditions, and un-cooperative behavior were excluded from the study.

结局指标

主要结局

DIFFERENTIATE BETWEEN REVERSIBLE AND IRREVERSIBLE PULPITIS interms of interleukin 6 levels

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方
Matta Navya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Matta Navya

anil neerukonda institute of dental sciences

研究点 (1)

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