| CTRI Number |
CTRI/2025/11/097752 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
How Surface design affects germ growth on Clear Aligners : A comparison between new Direct printed and regular thermoformed aligners. |
|
Scientific Title of Study
|
Comparative evaluation of Surface properties and Biofilm growth on 3D
printed and thermoformed Clear aligners – An In Vivo prospective study |
| 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 Robin Mathew Neerumtharappel |
| Designation |
Professor |
| Affiliation |
Terna Dental College and Hospital |
| Address |
Room no 306, 3rd floor , Department of Orthodontics Terna dental College and hospital,
Plot No 12 Terna Campus Rd, Opposite Railway Station, Sector 22,Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9930851339 |
| Fax |
|
| Email |
robin.23pden102@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Robin Mathew Neerumtharappel |
| Designation |
Professor |
| Affiliation |
Terna Dental College and Hospital |
| Address |
Room no 306, 3rd floor , Department of Orthodontics Terna dental College and hospital,
Plot No 12 Terna Campus Rd, Opposite Railway Station, Sector 22,Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9930851339 |
| Fax |
|
| Email |
robin.23pden102@student.nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Robin Mathew Neerumtharappel |
| Designation |
Professor |
| Affiliation |
Terna Dental College and Hospital |
| Address |
Room no 306, 3rd floor , Department of Orthodontics Terna dental College and hospital,
Plot No 12 Terna Campus Rd, Opposite Railway Station, Sector 22,Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9930851339 |
| Fax |
|
| Email |
robin.23pden102@student.nitte.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Robin Mathew Neerumtharappel |
| Address |
Plot No 12, Terna Campus Rd, opposite Railway Station, o Sector 22, Nerul, Navi Mumbai, Maharashtra 400706 |
| 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 |
| Dr Robin Mathew Neerumthrappel |
Terna Dental College and Hospital |
Room no 306, 3rd floor , Department of Orthodontics Terna dental College and hospital,
Plot No 12 Terna Campus Rd, Opposite Railway Station, Sector 22,Nerul, Navi Mumbai
Thane
MAHARASHTRA |
9930851339
robin.23pden102@student.nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TERNA DENTAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D printed |
wearing the 3D printed aligners for 2 weeks |
| Comparator Agent |
Thermoformed aligner |
wearing the thermoformed aligner for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 years to 40 years with healthy permanent dentition, healthy
periodontium, and excellent oral hygiene.
Patients that require mild correction of malocclusion within the scope of Clear aligner
treatment. |
|
| ExclusionCriteria |
| Details |
Patients with Craniomandibular disorders, and /or any systemic conditions
Patients with Pathological conditions such as Bruxism and clenching
Patients who smoke or consume tobacco
Patients with poor oral hygiene or poor perceived compliance
Patients who are pregnant or are breastfeeding
Immunocompromised patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surface properties and Biofilm growth. |
Baseline and After 2 weeks of intra oral use |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
none |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/12/2025 |
| 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="0"
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
|
Study Overview
This split-mouth clinical study investigates surface properties and biofilm formation on two types of clear aligners 1. direct-printed and 2. Thermoformed aligners, used in mild malocclusion cases. Each patient receives both aligner types, randomly assigned to either arch, with a passive Zero aligner used initially for standardization. Patient Protocol
Participants wear aligners more than 20 hours/day for 14 days, clean them daily, except Day 14, and report compliance via a 3-point Likert scale. Aligner Fabrication
All aligners are fabricated by a certified orthodontist following industry and manufacturer protocols. Sample Processing
After 14 days, aligners are bisected: One half is cleaned and analyzed for surface roughness with a profilometer and morphology using a SEM. The other half is used for biofilm mass evaluation in saline solution. Statistical Analysis
Data will be analyzed using SPSS v21. Normality will be tested using Shapiro-Wilk/Kolmogorov-Smirnov tests. If data is normal then ANOVA, t-tests, and Pearson’s correlation will be applied If not, Kruskal-Wallis, Mann-Whitney, and Spearman’s correlation will be applied
|