| CTRI Number |
CTRI/2023/10/058289 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate and Compare the Colour Change of Shape Memory 3D
Printed Aligners with Conventional Clear Aligners |
|
Scientific Title of Study
|
Comparison of optical properties of 3D printed shape memory orthodontic aligners and conventional thermoformed clear aligners |
| 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 Toni Lego |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department NO.3 Ground Floor, Surajkund Road,
Faridabad
HARYANA
121004
India |
| Phone |
7453969325 |
| Fax |
|
| Email |
tonilego6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Toni Lego |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department NO.3 Ground Floor, Surajkund Road
Faridabad
HARYANA
121004
India |
| Phone |
7453969325 |
| Fax |
|
| Email |
tonilego6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitesh Wadhwa |
| Designation |
Professor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department NO.3 Ground Floor, Surajkund Road,
Faridabad
HARYANA
121004
India |
| Phone |
9654581531 |
| Fax |
|
| Email |
jitesh.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department NO.3 Ground Floor Surajkund Road Faridabad, Haryana
|
|
|
Primary Sponsor
|
| Name |
Dr Toni lego |
| Address |
Manav Rachna Dental College, School of Dental Sciences, MRIIRS, Department NO.3 Ground Floor Surajkund Road Faridabad, Haryana |
| 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 |
| DrToni Lego |
MANAV RACHNA DENTAL COLLEGE |
School of Dental Sciences, Department NO.3, Ground Floor Surajkund Road
Faridabad
HARYANA |
7453969325
tonilego6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M262||Anomalies of dental arch relationship, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional thermoformed aligne |
Optical properties of Conventional thermoformed(PET-G) will be evaluated and compared with Shape memory 3D printed aligner after 14 days of clinical use. |
| Intervention |
Shape memory 3D printed aligner |
Optical Properties of 3D printed shape memory aligners will be evaluated by spectrophotometer after 14 days of clinical use |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. Decayed, Missing and Filled Teeth (DMFT) score less than 2
2. OHI-S score less than 3
3. No previous history of orthodontic treatment |
|
| ExclusionCriteria |
| Details |
1. Smoker
2. Bruxism
3. Eating habits of any formed of tobacco and betel paan |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change in optical property of 3D Printed shape memory aligner and compare it conventional aligner |
Baseline, 7 days and 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to see the patient perception of the new shape memory 3D printed aligner material , its abilty to deliver orthodontic force & the pain felt by participant |
8 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
10/10/2023 |
| 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="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
|
In this study, the color stability and optical properties
of two types of dental aligners—3D printed shape memory polymer aligners and
conventional PET-G aligners—is going to tested. The aligners are going to be
subjected to various intraoral conditions, and their absorbance and
transmittance properties will be measure using a spectrophotometer within the
visible light spectrum. Participants will be instructed to wear the aligners
continuously for 14 days, with removal during brushing and eating. After
retrieval, the aligners will be analyzed, and the data will be used to compare
their performance. This study aims is to provide insights into the suitability
of each aligner type for practical dental applications based on their color
stability and optical characteristics |