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临床试验/CTRI/2024/11/077028
CTRI/2024/11/077028尚未招募2/3 期

Effects of Non-Steroidal anti- inflammatory drugs on pulp sensibility test on diabetic patients with symptomatic irreversible pulpitis - A Double Blinded Randomized Clinical Trial

Dr Rajeswari. SV1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Pulp Sensibility Test and Responsiveness of Dental Pulp

研究概览

简要总结

Diabetes mellitus is a chronic inherited or acquired disorder caused by low production or ineffectiveness of insulin produced by the pancreas glands. Diabetes is a metabolic disease that is induced because of hyperglycemia. Hyperglycemia may result from either impairment of secretion or malfunction of insulin or both. There are several types of diabetes, but type 2 diabetes is the most frequent form.

 Diabetes mellitus not only induces dental pulp metabolic changes, but also it has been shown that it can influence both sensory and vascular structures. Therefore, it can be hypothesized that diabetes might affect pulp responses to sensibility tests. Pulpal sensibility tests, such as the cold, heat, and electric pulp tests (EPT) are important tools in endodontic diagnosis. The cold test is one of the most common endodontic diagnostic tests for the indirect assessment of the pulp vitality. It is usually performed in combination with EPT to increase the validity and reliability of the findings. Thisclinical trial aims to interpret and analyze the pulp sensibility in controlled Type II Diabetics and Healthy patients with symptomatic irreversible pulpitis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • Symptomatic irreversible pulpitis with VAS more than 85 mm on the 100 mm pain scale Type 2 Diabetics with HbA1c less than or equal to 6.5 Normal Patients with SIP and VAS more than 85 mm on the 100 mm pain scale.

排除标准

  • Other systemic diseases Pregnancy and lactation NSAIDs intake 12 hours prior to testing Pulp Stones and other abnormalities Abscesses Patient on other drugs like corticosteroids Non consenting patients Drug Allergies.

结局指标

主要结局

Pulp Sensibility Test and Responsiveness of Dental Pulp

时间窗: 20 min 40 min and 60 mins

次要结局

  • Effect of Age and Gender with logistic regression on the pulp sensibility of diabetic patients(20 min 40 min and 60 mins)

研究者

发起方
Dr Rajeswari. SV
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Rajeswari SV

Meenakshi Ammal Dental College and Hospital

研究点 (1)

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