| CTRI Number |
CTRI/2025/09/094206 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying Tiny Plastic Release from Clear Dental Aligners in Everyday Use |
|
Scientific Title of Study
|
Analyzing microplastic release from orthodontic aligners : An
In-vivo approach |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthick P |
| Designation |
Post graduate student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
E-block, Chettinad Dental College and Research Institute, Chettinad health city, Kelambakkam,
Kancheepuram - 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8870334984 |
| Fax |
|
| Email |
karthickpalanivel99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saravanakumar S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
E-block, Chettinad Dental College and Research Institute, Chettinad health city, Kelambakkam,
Kancheepuram - 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9894085953 |
| Fax |
|
| Email |
saro_sk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthick P |
| Designation |
Post Graduate Student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
E-block, Chettinad Dental College and Research Institute, Chettinad health city, Kelambakkam,
Kancheepuram - 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8870334984 |
| Fax |
|
| Email |
karthickpalanivel99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College and Research Institute |
| Address |
E-block, Chettinad Dental College and Research Institute, Chettinad health city, Kelambakkam,
Kancheepuram - 603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Karthick P |
Chettinad Dental College and Research Institute |
E-block, Chettinad Dental College and Research Institute, Chettinad health city, Kelambakkam,
Kancheepuram - 603103
Kancheepuram
TAMIL NADU |
8870334984
karthickpalanivel99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE HUMAN ETHICS COMMITTEE CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metal braces |
Participants using traditional metal braces |
| Intervention |
Polyethylene terephthalate (PET) |
Participants will wear PET aligners for 2 weeks |
| Intervention |
Polyethylene terephthalate glycol (PETG) |
Participants will wear PETG aligners for 2 weeks |
| Intervention |
Polyurethane (PU)
|
Participants will wear PU aligners for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with moderate to mild orthodontic
malocclusions requiring clear aligner treatment
2. Ability to commit to regular follow-up appointments for
the duration of the study.
3. Non-smokers to eliminate potential confounding factors
related to oral health and material degradation
4. No known allergies or sensitivities to materials used in
orthodontic aligners (PET, PETG, PU)
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe malocclusions requiring non-clear
aligner treatment options such as surgery
2. Patients with a history of allergic reactions to materials
used in clear aligners (PET, PETG, PU)
3. Patients with temporomandibular joint disorders (TMD)
that may affect aligner wear or exacerbate discomfort
during treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study found that PET, PETG, and PU aligners release
microplastics, with varying amounts, while metal braces
showed no microplastic release, emphasizing health and
sustainability concerns.
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
05/01/2026 |
| 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="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
|
Clear orthodontic aligners are widely popular due to their aesthetic appeal and functional advantages. However, concerns about the release of microplastics (MPs) from these aligners have emerged, as plastic materials are susceptible to mechanical degradation. Ingesting MPs has been associated with oxidative stress, inflammatory lesions, and other health issues, including disruptions to gut microbiota, respiratory complications, cardiovascular risks, and cognitive function. This study investigates the in-vivo release of MPs from orthodontic aligners made of polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), and polyurethane (PU), with a control group of patients using traditional metal braces. |