| CTRI Number |
CTRI/2026/01/100895 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two types of clear aligners for correcting crowded lower front teeth in adults |
|
Scientific Title of Study
|
Evaluation of the efficacy of Direct 3D-printed aligners with that of Thermoformed aligners in resolving lower anterior crowding among adults- A single-blind randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhammed Vasil U N |
| Designation |
Junior Resident |
| Affiliation |
Government dental college, Kozhikode |
| Address |
Room no 21, Department of Orthodontics, Government Dental College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9947972079 |
| Fax |
|
| Email |
muhammedvasilun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen S |
| Designation |
Head of the department |
| Affiliation |
Government dental college, Kozhikkode |
| Address |
Department of Orthodontics, Government Dental College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9846274491 |
| Fax |
|
| Email |
Orthonair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen S |
| Designation |
Head of the department |
| Affiliation |
Government dental college, Kozhikkode |
| Address |
Department of Orthodontics, Government Dental College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9846274491 |
| Fax |
|
| Email |
Orthonair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College,
Government Medical College Campus, Kozhikode, Kerala - 673008
|
|
|
Primary Sponsor
|
| Name |
Muhammed Vasil U N |
| Address |
Room no 21, Department of Orthodontics, Government Dental College, Kozhikode, Kerala - 673008 |
| Type of Sponsor |
Other [self] |
|
|
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 Muhammed Vasil U N |
Government Dental College, Kozhikode |
Room no 21, Department of Orthodontics, Government Dental College, Kozhikode
Kozhikode
KERALA |
9947972079
muhammedvasilun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College, Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Direct 3D-Printed Aligners |
After the pre-treatment evaluation Digital intraoral scans will be taken using a high-precision
intraoral scanner (Helios-500, Changzhou Sifary Medical Technology, China) and create a 3D
digital model. Both dental arches and supporting tissues will be scanned. Once the scanning
procedure is completed, it is then converted into the Standard Tessellation Language (STL)
files.
The STL files are then imported into DAD (Direct Aligners Design) Software, where virtual
treatment planning is made. The software automatically generates the number of aligners
necessary to reach the final predictive model. Once planning is completed, the aligners will be
directly 3D-printed using biocompatible resin-based material TA-28 (Graphy, Geumcheon-gu
Seoul, South Korea) in a 3D DLP (Digital Light Processing) printer - AccuFab-D1s (Shining
3D, Hangzhou, Zhejiang, China).
Once 3D fabrication is completed, it is UV cured by using Tera Harz Cure (Graphy,
Geumcheon-gu Seoul, South Korea)
The aligners will replace every 10 days, and patients will be instructed to wear the clear aligners
at least 20 hours/day.
Orthodontic appointments will be scheduled every month. |
| Comparator Agent |
Thermoformed Aligners |
Digital intraoral scans will be taken using a high-precision intraoral scanner (Helios-500,
Changzhou Sifary Medical Technology, China) and create a 3D digital model, and prepare for
digital setup. Digital setup will be performed using MAESTRO3D software (AGE Solutions,
Italia)
Attachment architecture will be standardized with MAESTRO3D software (AGE Solutions,
Italia)
The digital models generated by the software will be printed using a 3D printer AccuFab-D1s
(Shining 3D, Hangzhou, Zhejiang, China) using the resin material Phrozen 4k (Phrozen Tech
Co., Ltd. Hsinchu City, Taiwan (R.O.C.))
Clear aligners will be fabricated using a 0.75-mm biocompatible thermoplastic transparent
sheet Scheu Duran (SCHEU-DENTAL Am Burgberg, Iserlohn, Germany) using a vacuum
forming machine.
Aligner trimming, polishing, disinfecting, packing, and delivering to the patient will be done
for each case.
In the first appointment, the first aligners will be applied after attachment bonding using the
attachments template,
The attachments will be made using Universal Light-Cured Radiopaque Flowable Composite
G-ænial™ Universal Flo (GC Corporation, Bunkyo-ku, Tokyo, Japan)
Instructions will be given to wear the aligners 20 hours a day
Patients will be instructed to wear each aligner for 10 days
Patient will be reviewed at every month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with fully erupted permanent dentition (excluding
third molar) irrespective of gender
Healthy, compliant and motivated patients who can visit clinic regularly.
Angle’s class I malocclusion with Mild to Moderate lower anterior crowding.
Non extraction treatment plan.
No history of previous orthodontic treatment. |
|
| ExclusionCriteria |
| Details |
Gross gingival/periodontal problems in lower anterior teeth
Presence of dental anomalies in the lower anterior teeth
Patients with craniofacial syndromes or genetic disorders affecting dentofacial development
Prosthetic replacements in lower anterior teeth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the Little’s Irregularity Index |
at baseline (T0), 2 months(T1), 4 months(T2) and post-treatment(T3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of correction of crowding |
4 weeks, 8 weeks, 12 weeks, 16 weeks ,20 weeks, 24 weeks |
| Treatment Duration Comparison |
24 weeks |
| Comparison of Number of Aligners Used |
24 weeks |
| Change in Mandibular Incisor Inclination (IMPA) |
24 weeks |
| Change in mandibular inter-canine width |
24 weeks |
| Amount of Interproximal Reduction (IPR) |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="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
|
The purpose of the study is to compare the efficacy of direct 3D-printed aligners and thermoformed aligners in resolving mild to moderate lower anterior crowding in adult patients. The study aims to evaluate the changes in littles irregularity index along with rate of correction of crowding, treatment duration comparison, number of aligners used, change in mandibular incisor inclination, change in mandibular inter-canine width and amount of interproximal reduction needed The null hypothesis states that there is no significant difference in the efficacy in the correction of lower anterior crowding with direct 3D-printed aligners and thermoformed aligners. |