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临床试验/CTRI/2024/10/075462
CTRI/2024/10/075462已完成3 期

Effect Of Endodontic Treatment On The HbA1c And Gingival Crevicular Fluids Levels Of NLRP3 In Type 2 Diabetes Mellitus Patients With Pulp Necrosis And Symptomatic Apical Periodontitis – A Cross Sectional Study​

Manav Rachna Dental College1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in the levels of HbA1c and NLRP3 levels in Gingival Crevicular Fluid after non-surgical endodontic treatment.

研究概览

简要总结

The research aims to evaluate the Effect of Endodontic treatment on the serum HbA1c and Gingival Crevicular Fluid levels of NLRP3 in Type 2 Diabetes Mellitus patients with pulp necrosis and symptomatic apical periodontitis. The study design is a Cross-sectional study. Sixty patients diagnosed with pulp necrosis and symptomatic apical periodontitis will be allotted into 2 groups of 30 each.  One group will have the oral disease with overlying Type 2 Diabetes Mellitus. Group 2 will have systemically healthy patients with pulp necrosis and symptomatic apical periodontitis. Endodontic treatment will be done and serum levels of HbA1c and gingival crevicular fluid levels of NLRP3 will be evaluated one week post-treatment.  Null Hypothesis- There is no difference in the HbA1c levels and NLRP3 Gingival Crevicular Fluid levels of patients diagnosed with Symptomatic apical Periodontitis after Non-surgical endodontic treatment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patient with SAP in one molar tooth and Type 2 DM
  • Patients with SAP in one molar tooth and no systemic disease
  • Patients with no other systemic disease.

排除标准

  • Pregnant or lactating patients Patients with systemic disease other than Type 2 Diabetes Mellitus Tooth with furcation involvement Patients with uncontrolled diabetes Mellitus.

结局指标

主要结局

Change in the levels of HbA1c and NLRP3 levels in Gingival Crevicular Fluid after non-surgical endodontic treatment.

时间窗: HbA1c blood levels shall be analyzed before endodontic treatment followed by 3 and 6 months after endodontic treatment

次要结局

  • The HbA1c levels in serum shall also be evaluated after endodontic treatment(one week after completion of endodontic treatment)

研究者

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

Dr Dax Abraham

Manav Rachna Dental College

研究点 (1)

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