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临床试验/CTRI/2024/04/066468
CTRI/2024/04/066468已完成不适用

Comparison of pulp sensibility test responses in Type 2 Diabetes Mellitus patients and healthy individuals in Indian sub population: A clinical trial

ITS Dental College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
To evaluate and compare the values of electric pulp test response in patients suffering from controlled type 2 diabetes mellitus, uncontrolled type 2 diabetes mellitus and healthy individuals.

研究概览

简要总结

Diabetes mellitus is the most common metabolic disorder that not only induces metabolic changes in the pulp but also influences both sensory and vascular structures. It has been shown that pulp sensibility tests may be influenced by systemic diseases. There is less information regarding the responses of type 2 diabetes patients to the pulp sensibility tests.Therefore, the need of the study to be done will help in improving the best intervention methods for diabetic patients and help clinicians to plan the specific treatment modality for a diabetic patient. The study will be done to evaluate and compare the response of the dental pulp to pulp sensibility tests (cold and electrical) in patients suffering from controlled type 2 diabetes mellitus, uncontrolled type 2 diabetes mellitus and healthy individuals.The forthcoming clinical study will be carried out within the Department of Conservative Dentistry and Endodontics at I.T.S. Dental College, Hospital, and Research Centre in Greater Noida, Uttar Pradesh. The sample size for the study will encompass a total of 300 patients drawn from the Outpatient Department (O.P.D) of the Department of Conservative Dentistry and Endodontics, adhering meticulously to predefined inclusion and exclusion criteria. They will be divided into three groups:-

Group A- 100 patients will be examined with controlled type 2 diabetes mellitus (patients who are on oral medication or insulin injections with fasting plasma glucose less than 126mg/dl, random plasma glucose less than 200mg/ dl, HbA1c less than 7%)

Group B- 100 patients will be examined with uncontrolled type2 diabetes mellitus (Patients who have fasting plasma glucose levels more than 126mg/dl, random plasma glucose levels more than 200 mg/dl, HbA1c more than 7%)

Group C- 100 patients, age and sex-matched patients with no history of diabetes and normal glucose tolerance will serve as control subjects.

  1. Electric pulp testing- Selected tooth to be tested will be dried and isolated with cotton rolls. A thin layer of toothpaste will be applied on buccal surface of the crown. An electric pulp tester probe will be placed on the sound coronal third of labial surface. Thereafter the patient will be asked to inform whenever he or she feels tingling pain or any sensation during activation of the electric pulp tester.

The number indicating the pulp tester current will be recorded as the patient response.

The sensibility tests will be performed with a 1-2 minute delay in order to minimise the effect of one test over the other.

Cold test - the cold test will be performed with Endo frost. The tooth will be dried and isolated with cotton rolls. A cotton pellet will be sprayed and placed on the middle third of the crown of each tooth for 5 seconds or as soon as the patient raises his or her hand to indicate feeling either pain or a cold sensation. Each pellet will be sprayed no more than 2 times and then a fresh pellet will be used for the next tooth.

Patients will mark the response on Numeric pain rating scale. The time interval between the cold application and patient response will also be recorded.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • consenting to participate in the study.
  • have at least 2 intact or minimally restored premolar teeth.
  • with controlled type 2 diabetes mellitus.
  • with uncontrolled type 2 diabetes mellitus (fasting plasma glucose levels more than 126mg/dl, random plasma glucose levels more than 200 mg/dl, HbA1c more than 7%) -age and sex matched patients who report no history of diabetes and normal glucose tolerance.

排除标准

  • 1.Presence of any injury to head, neck and nervous system as well as other health conditions like cancer, pregnancy.
  • 2.Patient taking drugs affecting CNS and anti inflammatory drugs.
  • 3.History of trauma, severe periodontal disease, extensive caries or restoration, incompletely developed root, sclerosed canals, apical periodontitis, orthodontic brackets or recent history of orthodontic treatment, teeth that had root canal treatment and teeth with crowns.

结局指标

主要结局

To evaluate and compare the values of electric pulp test response in patients suffering from controlled type 2 diabetes mellitus, uncontrolled type 2 diabetes mellitus and healthy individuals.

时间窗: at baseline

To evaluate and compare the values of cold test response in patients suffering from controlled type 2 diabetes mellitus, uncontrolled type 2 diabetes mellitus and healthy individuals.

时间窗: at baseline

次要结局

  • to find a link between systemic disease like diabetes mellitus & the responses to pulp sensibility testing.(at the end of the study duration which is 1 year 5 months)

研究者

发起方
ITS Dental College Hospital and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr ANNEYSHA BHATTCHARYYA

I.T.S. DENTAL COLLEGE, GREATER NOIDA

研究点 (1)

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