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临床试验/CTRI/2024/06/069197
CTRI/2024/06/069197招募中不适用

A comparative analysis on effects of statin pharmacotherapy on pulp chamber calcification - A 3-dimensional radiographic analysis on Indian population

Neha1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年6月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
Patient with cardiovascular

研究概览

简要总结

The aim of the study is to evaluate and compare the pulp chamber calcification amongst healthy controls patients with cardiovascular disease not taking statin medication and patients with cardiovascular disease on statin medication using three dimensional volumetric analysis. Patients will be allotted in three groups. Group 1 will constitute healthy individuals without taking any medications Group 2 will constitute cardiovascular patients without any medication Group 3 will constitute cardiovascular patients taking statin medication. CBCT scans will be retrieved from the software database from January 2020 to March 2023 and utilized the patient detailed medical history and dental records to allocate them into the test group and control group. A sample size of 75 with 25 in each of the three group will be taken. The inclusion criteria involve patient with 30 to 45 years of age and presence of healthy either first or second mandibular molars. CBCT scan with the presence of caries large restorations attrition periodontitis previous pulp cap treated teeth endodontically treated teeth patients with history of clenching or grinding will be excluded. Group 1 patients with any systemic diseases and the other two groups with systemic diseases like renal lithiasis gout cholelithiasis and diabetes mellitus will be excluded from the study.

CBCT scans of patients will be taken from PAPAYA 3D. A third party software ONDEMAND 3D will be used for the volumetric analysis. The scan images will be reconstructed and evaluated in different planes including sagittal coronal axial sections. Skilled oral radiologists will use the OnDemand3D software to interpret the images. The data analysis will be performed using the statistical software SPSS version 16.0.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • patient with 30 to 45 years of age and presence of healthy either first or second mandibular molars group 1 healthy patient group 2 cardiovascular patient group 3 cardiovascular patient taking statin medication.

排除标准

  • CBCT scan with the presence of caries large restorations attrition periodontitis previous pulp cap treated teeth endodontically treated teeth patients with history of clenching or grinding group 1 patients with any systemic disease group 2 and 3 patients with systemic disease like renal lithiasis gout cholelithiasis diabetes mellitus were excluded from the study.

结局指标

主要结局

Patient with cardiovascular

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

disease taking statin

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

medication may have

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

increased incidence of pulp

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

chamber calcification

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

followed by cardiovascular

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

patient without taking any

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

medication compared to healthy individual

时间窗: patients taking statin medication for more than 5 years | patients having cardiovascular disease more than 5 years

次要结局

  • Patient with cardiovascular(disease taking statin)

研究者

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

NEHA

Manav Rachna Dental College

研究点 (1)

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