| CTRI Number |
CTRI/2024/10/076026 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Biomarkers In Blood From Dental Pulp |
|
Scientific Title of Study
|
Evaluation of biomarkers in pulpal blood of teeth with dental caries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rednam Lakshmi Praneeth |
| Designation |
Post graduate |
| Affiliation |
Thaimoogambigai Dental College |
| Address |
Department of Endodontics, 3rd FLOOR, Thaimoogambigai Dental College, Golden George Nagar, Mugappair, Chennai,
600 107
Tamil Nadu, India,
Kancheepuram
TAMIL NADU
600107
India |
| Phone |
9948955835 |
| Fax |
|
| Email |
rednampraneeth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.AR Pradeep Kumar |
| Designation |
Guide |
| Affiliation |
Thaimoogambigai Dental College |
| Address |
Department OF Endodontics, 3rd Floor, Thaimoogambigai Dental College, Golden George Nagar
Mugappair
Chennai, 600 107.
Tamil Nadu, India
TAMIL NADU
600107
India |
| Phone |
9948955835 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rednam Lakshmi Praneeth |
| Designation |
Post graduate |
| Affiliation |
THAIMOOGAMBIGAI DENTAL COLLEGE |
| Address |
Department of Endodontics, 3rd floor, Thaimoogambigai Dental College, Golden George Nagar
Mugappair
Chennai - 600 107
Tamil Nadu, India
TAMIL NADU
600107
India |
| Phone |
9948955835 |
| Fax |
|
| Email |
rednampraneeth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thaimoogambigai Dental College, Department of Endodontics, Muggapair, Chennai, 600107.India |
|
|
Primary Sponsor
|
| Name |
Rednam Lakshmi Praneeth |
| Address |
Golden George Nagar
Mugappair
Chennai - 600 107
Tamil Nadu, IndiaGolden George Nagar
Mugappair
Chennai - 600 107
Tamil Nadu, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Thaimoogambigai dental college |
Golden George Nagar
Mugappair
Chennai - 600 107
Tamil Nadu, IndiaGolden George Nagar
Mugappair
Chennai - 600 107
Tamil Nadu, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR AR Pradeep Kumar |
Thaimoogambigai Dental College |
Department of Endodontics, 3rd floor,Thaimoogambigai dental college, Golden George Nagar
Mugappair,
Chennai, 600 107
Tamil Nadu, India.
Kancheepuram
TAMIL NADU |
9840135711
rednampraneeth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE-THAIMOOGAMBIGAI DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biomarker in pupal blood of young patient. |
To see MMP 9 levels in pulpal blood once pulp got exposed after access opening within 5 sec. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients Between Ages 20 and 80 Years.
Irreversible pulpitis.
|
|
| ExclusionCriteria |
| Details |
Patients on NSAIDs [non-steroidal anti-inflammatory drugs]
Patients with systemic diseases such as diabetes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| MMP Levels From Pulpal Blood. |
Immediately After Access Opening Within 5 Secs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess The Inflammatory Status Of Pulp. |
Within 5 Sec Of Access Opening. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/11/2024 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
To Look For MMP Levels In Pulpal Blood, So That We Can Assess Pulpal Inflammation Status. Access opening Done under rubber dam isolation after pulpal exposure. Pulpal blood was collected by paper point and stored in phosphate-buffered saline solution for assessment by ELISA |