| 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
|
|
|
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
|
|
|
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. |