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CTRI Number  CTRI/2024/06/069197 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Effects of statin medication and cardiovascular disease on pulp chamber calcification - A 3-dimensional radiographic analysis on Indian population 
Scientific Title of Study   A comparative analysis on effects of statin pharmacotherapy on pulp chamber calcification - A 3-dimensional radiographic analysis on Indian population 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEHA 
Designation  Post Graduate student  
Affiliation  Manav Rachna Dental College 
Address  Room No 7 2nd Floor Department of Conservative Dentistry and Endodontics Manav Rachna Dental College Surajkund Badkhal Road Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  9910096337  
Fax    
Email  neha9910096337@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NEHA 
Designation  Post Graduate student  
Affiliation  Manav Rachna Dental College 
Address  Room No 7 2nd Floor Department of Conservative Dentistry and Endodontics Manav Rachna Dental College Surajkund Badkhal Road Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  9910096337  
Fax    
Email  neha9910096337@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NEHA 
Designation  Post Graduate student  
Affiliation  Manav Rachna Dental College 
Address  Room No 7 2nd Floor Department of Conservative Dentistry and Endodontics Manav Rachna Dental College Surajkund Badkhal Road Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  9910096337  
Fax    
Email  neha9910096337@gmail.com  
 
Source of Monetary or Material Support  
Room no 7 Second floor Department of Conservative Dentistry and Endodontics Manav Rachna Dental College Surajkund Badkhal Road Faridabad Haryana 121004 
 
Primary Sponsor  
Name  Neha 
Address  Room NO 7 Second Floor Department of Conservative Dentistry and Endodontics Manav Rachna Dental College Surajkund Badkhal Road Faridabad Haryana 121004 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Alpa Gupta  Manav Rachna Dental College  Room no 7 2nd floor Department of Conservative Dentistry and Endodontics Manav Rachna Dental College SurajKund Road Badkhal Faridabad Haryana 121004
Faridabad
HARYANA 
9050312010

alpagupta2008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Manav Rachna Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  group 1 healthy individuals group 2 cardiovascular patient not on any medication group 3 cardiovascular patient on statin medication 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Patient with cardiovascular
disease taking statin
medication may have
increased incidence of pulp
chamber calcification
followed by cardiovascular
patient without taking any
medication compared to healthy individual 
patients taking statin medication for more than 5 years
patients having cardiovascular disease more than 5 years 
 
Secondary Outcome  
Outcome  TimePoints 
Patient with cardiovascular
disease taking statin
medication may have
increased incidence of pulp
chamber calcification
followed by cardiovascular
patient without taking any
medication compared to healthy individual 
Patient with cardiovascular
disease for more than 5 years 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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