| CTRI Number |
CTRI/2025/08/093802 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Microplastics in Oral and Dental tissues |
|
Scientific Title of Study
|
Evaluation of Microplastics Dental pulp |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shamaa Anjum A |
| Designation |
PG |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
402, 3rd floor, Department of conservative dentistry and endodontics, Thai moogambigai dental college and hospital, Gangai Amman Kovil street, Golden George nagar, Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
917550118371 |
| Fax |
|
| Email |
drshamaanjum1107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AR Pradeepkumar |
| Designation |
Head of the Department |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
402, 3rd floor, Department of conservative dentistry and endodontics, Thai moogambigai dental college and hospital, Gangai Amman Kovil street, Golden George nagar, Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
919840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AR Pradeepkumar |
| Designation |
Head of the Department |
| Affiliation |
Thai Moogambigai Dental College and Hospital |
| Address |
402, 3rd floor, Department of conservative dentistry and endodontics, Thai moogambigai dental college and hospital, Gangai Amman Kovil street, Golden George nagar, Chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
919840135711 |
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
|
Source of Monetary or Material Support
|
| 402, 3rd Floor, Department of Conservative Dentistry and Endodontics, Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai-600095, Tamil Nadu, India
|
|
|
Primary Sponsor
|
| Name |
Shamaa Anjum A |
| Address |
402, 3rd Floor, Department of Conservative Dentistry and Endodontics, Gangai Amman Koil Street, Golden George Nagar, Mogappair, Chennai-600095, Tamil Nadu, India |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Shamaa Anjum A |
Thai Moogambigai Dental college and hospital |
02 3rd floor department of conservative dentistry and endodontics Gangai amman koil street Golden george nagar mogappair Chennai Tamil Nadu Chennai
TAMIL NADU
Chennai
TAMIL NADU |
7550118371
drshamaanjum1107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics review board of Dr M.G.R Educational and Research Institute,University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
digestion with chemicals |
digestion of dental pulp, enamel, dentin, saliva, sputum and blood. |
| Comparator Agent |
microplastics |
different microplastics taken as control |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with pulpitis,
patients advised for Tooth extraction
|
|
| ExclusionCriteria |
| Details |
grossly decayed tooth and root stumps |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Microplastics in Dental Pulp of teeth diagnosed with pulpitis and extracted teeth |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of Microplastics in Dental Pulp of teeth diagnosed with pulpitis & extracted teeth |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to evaluate the presence or absence of microplastics in pulp , enamel and dentin of teeth diagnosed as pulpitis and saliva, sputum and blood of corresponding patients. Pulp tissue,enamel and dentin from extracted teeth were also collected. Saliva,sputum and blood was collected from the corresponding patients. The pulp tissue,enamel , dentin, saliva , sputum and blood samples will be digested and analysed using Raman Microspectroscope / FTIR |