| CTRI Number |
CTRI/2024/05/066964 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the color changes and its properties in different set of aligners used after wear by the patient. |
|
Scientific Title of Study
|
Comparative Evaluation of color stability and optical properties of PET, PETG and TPU based aligner materials: an in vivo 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 |
Niharika Bhandari |
| Designation |
MDS student |
| Affiliation |
Sudha rustagi college of dental sciences, faridabad |
| Address |
Department of orthodontics, Room no. 4, Sudha Rustagi College of Dental Sciences, Sector 89, Faridabad
Faridabad
HARYANA
121002
India |
| Phone |
7827528937 |
| Fax |
|
| Email |
niharikabhandari737@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gurkeerat Singh |
| Designation |
HOD and Professor |
| Affiliation |
Sudha rustagi college of dental sciences, faridabad |
| Address |
Department Of Orthodontics, Room No. 4, Sudha Rustagi College of Dental Sciences, sector 89, Faridabad,
Faridabad
HARYANA
121002
India |
| Phone |
9811063930 |
| Fax |
|
| Email |
drgurkeeratsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Niharika Bhandari |
| Designation |
MDS student |
| Affiliation |
Sudha rustagi college of dental sciences, faridabad |
| Address |
Department of Orthodontics, Room no.4 ,Sudha rustagi college of dental sciences, sector 89,faridabad,
K916 piyush heights, sector 89 faridabad
Faridabad
HARYANA
121002
India |
| Phone |
7827528937 |
| Fax |
|
| Email |
niharikabhandari737@gmail.com |
|
|
Source of Monetary or Material Support
|
| Niharika Bhandari(myself)
Department of Orthodontics, Room no. 4, Sudha Rustagi College of Dental Sciences, Faridabad |
|
|
Primary Sponsor
|
| Name |
Niharika Bhandari |
| Address |
Department of Orthodontics, sudha rustagi college of dental sciences, faridabad, Haryana, country code 91 |
| 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 Niharika Bhandari |
sudha rustagi college of dental sciences, faridabad |
Department of orthodontics, Room no. 4, sector 89, greater faridabad , kheri more road
Faridabad
HARYANA |
7827528937
niharikabhandari737@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients willing for orthodontic treatment reporting to sudha rustagi dental college. |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
patient with good oral hygiene
patient with mild to moderate malocclusion
patient with good compliance to wear aligners at least 20-22 hours per day |
|
| ExclusionCriteria |
| Details |
patient with habits of smoking, tobacco which leads to stains.
distorted aligners
patient with GERD
patient with habit of bruxism |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| optical properties of aligners |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine which material is best for aligner fabrication |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/07/2024 |
| 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="0"
Days="21" |
|
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
|
This is a prospective, randomised double blind study of three aligner materials PET, PETG and TPU on 5 patients of each material which includes students and patients visiting in the department of orthodontics from Sudha Rustagi College of Dental Sciences willing for orthodontic treatment. Samples of each material will be taken and thermoformed using thermoforming machine. Two sets of aligners need to be fabricated at the start of the study. One set is sent for study and one is delivered to the patient. Optical properties of each aligner, in terms of absorbance/transmittance will be obtained, using FTIR spectrophotometer before delivering the aligners to the patient.
For each material we will carry out tests at interval of 7 days and 14 days after wear.
At 7th day of aligner wear, the aligners will be collected from the patient, washed with distilled water and immediately sent for the tests. An additional aligner of the same series or another set of series will be delivered to the patient to replace the aligner collected for test purposes. Similar methodology will be used for 14th day.
|