| CTRI Number |
CTRI/2025/03/082830 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An in vivo study assessing microplastics released in saliva of patients undergoing clear aligner therapy and their Histochemical effects in terms of estrogenicity, cytotoxicity and oxidative stress |
|
Scientific Title of Study
|
Assessment of Histochemical Effects of Microplastics Released during Clear Aligner Therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reuben Bensy Thomas |
| Designation |
First year post graduate student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics (Department number 9), Fifth floor,
AB Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9811708084 |
| Fax |
|
| Email |
reubenbensythomas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Crystal Runa Soans |
| Designation |
Reader |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics (Department number 9), Fifth floor,
AB Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
96112 00050 |
| Fax |
|
| Email |
drcrystalsoans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reuben Bensy Thomas |
| Designation |
First year post graduate student |
| Affiliation |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics (Department number 9), Fifth floor,
AB Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9811708084 |
| Fax |
|
| Email |
reubenbensythomas@gmail.com |
|
|
Source of Monetary or Material Support
|
| AB Shetty Memorial Institute of Dental Sciences,
Derlakatte, Mangaluru,
Karnataka,
India
575018 |
|
|
Primary Sponsor
|
| Name |
AB Shetty Memorial Institute of Dental Sciences |
| Address |
Derlakatte, Mangalore, Karnataka, 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 Reuben Bensy Thomas |
AB Shetty Memorial Institute of Dental Sciences |
Department of Orthodontics and Dentofacial Orthopaedics ( Department number 9),
AB Shetty Memorial Institute of Dental Sciences, Derlakatte, Mangaluru, Karnataka, India 575018
Dakshina Kannada
KARNATAKA |
9811708084
reubenbensythomas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, Nitte university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malocclusion (undergoing Clear Aligner Therapy) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1) Individuals opting for clear aligner therapy
2) Individuals between 18 years to 24 years of age
3) No previous history of orthodontic treatment
4) Individuals willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1) Individuals who use tobacco in any form
2) Individuals on medications for systemic conditions
3) Individuals under hormonal replacement therapy
4) Individuals with craniofacial syndromes
5) Individuals with poor oral hygiene
6) Individuals with poor periodontal conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Microplastics will be assessed using Fourier Transform Infrared spectroscopy
The sample will then be tested with:-
1) MTT Assay/ 3-(4,5- dimethylthiazol-2-yl)-2,5-Diphenyl Tetrazolium bromide assay:
To evaluate the cytotoxicity of microplastics on primary cultures of human
gingival fibroblasts.
2) MCF-7 cell line test: To assess estrogenicity of microplastics.
3) MPO Assay: To assess whether microplastics cause oxidative
stress. |
T0 : control (before onset of treatment)
T1: 1 day after onset of treatment
T2 : 14 days after onset of treatment
T3: 30 days after onset of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The results of this study will emphasize the necessity of adopting sustainable practices. The study aligns with the following Sustainable Development Goals i.e.
SDG 3 Good health & well being
SDG12 Responsible consumption & production |
The outcomes will be assessed at 12 months post start of study |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
07/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
AIM: The study aims to assess the histochemical effects due to microplastics released in saliva of patients undergoing clear aligner therapy. OBJECTIVES: 1. To assess the presence of microplastics in saliva of patients undergoing clear aligner therapy 2. To analyze the histochemical changes i.e. cytotoxicity, estrogenicity and oxidative stress caused by these microplastics
The saliva sample will be subjected to the following tests: a) Fourier Transform Infrared Spectroscopy (FTIR): To assess and characterize the microplastics present in the saliva sample b) MTT Assay/ 3-(4,5- dimethylthiazol-2-yl)-2,5-Diphenyl Tetrazolium bromide assay: To evaluate the cytotoxic effect of the microplastics on primary cultures of human gingival fibroblasts. c) MCF-7 cell line test: To assess whether microplastics have estrogenic effects. d) MPO Assay: To assess whether microplastics have the potential to cause oxidative stress.
|