跳至主要内容
临床试验/CTRI/2024/05/066690
CTRI/2024/05/066690尚未招募4 期

Comparison of gingival crevicular fluid levels of NLRP3 in patients diagnosed with pulp necrosis and symptomatic apical periodontitis before and after endodontic treatment

Karina1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
The NLRP3 levels in GCF may be increased and hence detectable in patients with Pulp Necrosis and Symptomatic Apical Periodontitis but will reduce after endodontic treatment

研究概览

简要总结

Patient’s consent will be obtained.

Group 1 will constitute healthy individuals with no evidence of caries and systemic disease. Group 2 will constitute patient diagnosed with pulpal necrosis and symptomatic apical periodontitis (systemically healthy).

1.  All subject will be diagnosed by using the standard and prescribed diagnostic tests and detailed medical history will be taken devoid of any systemic diseases.

2.   The patient will be asked to get a consent form from a physician indicating that the results of both their blood and urine reports are normal to rule out any systemic condition of a patient.

3.  Patient’s case history, oral examinations, oral health index will be carried out using artificial light, mouth mirror, and explorer. Pulp sensibility test will be carried out. Before the commencement of the study, the subject will receive detailed information about the study and written consent will be obtained.

4.     Patient will be advised to get oral prophylaxis done by a dental surgeon one week prior to GCF collection in order to proceed for further steps. Patient will be asked to perform regular oral hygiene procedures.

5.     Prevent them from eating and drinking 1 hour prior to sample collection.

Using the capillary method 10 microliters capillary tube gently tapped near the involved tooth till the desired volume of GCF will be obtained through capillary action.

6.    The sample will then transferred to an Eppendorf tube using air pressure till it will be collected at the bottom of the Eppendorf tube.

7.    The tubes will be carefully sealed and stored at a temperature of -80 degree Celsius until the ELISA tests will be conducted.

8.    Using similar method samples will be collected from the adjacent and the contralateral teeth and also from the caries-free individuals in the healthy group.

9.  Samples that will be contaminated with blood and saliva will be discarded and would be reassessed or another sample will be chosen followed by endodontic treatment.

10.  GCF sample will be collected 1 week after the completion endodontic treatment and ELISA test will be conducted.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with pulp necrosis and symptomatic apical periodontitis in a single tooth as per the clinical and pulp sensibility tests (according to the AAE guidelines)
  • Patients aged 18-40 years of age
  • Patients with no relevant medical history or absence of any systemic conditions
  • Non-smokers.

排除标准

  • Patients with periodontitis 2.Patients with multiple carious teeth
  • Patients with apical abscess (swelling) &/or sinus tract.

结局指标

主要结局

The NLRP3 levels in GCF may be increased and hence detectable in patients with Pulp Necrosis and Symptomatic Apical Periodontitis but will reduce after endodontic treatment

时间窗: One week after completion of endodontic treatment.

次要结局

  • N/A(N/A)

研究者

发起方
Karina
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Karina

Manav Rachna Dental College

研究点 (1)

Loading locations...

相似试验