| CTRI Number |
CTRI/2024/04/065614 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of indigenously developed coding and grading system for assessing facial esthetics among dental students and practitioners. |
|
Scientific Title of Study
|
To evaluate the accuracy and reproducibility of indigenously developed Profile, Smile and Dentogingival (PSD) coding and grading system for facial esthetics amongst BDS, MDS students and BDS and MDS practitioners. |
| 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 Shreya Shrivastava |
| Designation |
Post graduate student |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon, Chhattisgarh,India-491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7898098375 |
| Fax |
|
| Email |
sarashreya8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Javed Sodawala |
| Designation |
Professor and Head of Department |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon, Chhattisgarh, India- 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7000858658 |
| Fax |
|
| Email |
drjavedazher@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Shrivastava |
| Designation |
Post graduate student |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon, Chhattisgarh, India- 491441
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
7898098375 |
| Fax |
|
| Email |
sarashreya8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon, Chhattisgarh, India- 491441 |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Shrivastava |
| Address |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon, Chhattisgarh, India- 491441 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreya Shrivastava |
Chhattisgarh Dental College and Research Institute |
Room no. 6, Department of Orthodontics and Dentofacial Orthopedics, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon, Chhattisgarh, India-491441
Rajnandgaon
CHHATTISGARH |
7898098375
sarashreya8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhattisgarh Dental College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Trial participants will BDS students, BDS practitioners, MDS(Orthodontics) students and MDS(Orthodontics) practitioners |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. BDS students pursuing internship from a recognized dental college in India or equivalent
2.BDS practitioners who have studied from a recognized dental college in India or equivalent
3. MDS(Orthodontics) students studying from a recognized dental college in India or equivalent
4. MDS(Orthodontics) practitioners who have studied from a recognized dental college in India or equivalent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the accuracy of PSD coding system for facial esthetics by BDS internship students, MDS(Orthodontics) students, BDS practitioners, MDS(Orthodontics) practitioners.
2. To compare the reproducibility of PSD coding system for facial esthetics by BDS internship students, MDS (Orthodontics) students, BDS practitioners, MDS (Orthodontics) practitioners |
At the Baseline T0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To determine demographical differences. |
at the baseline T0 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/04/2024 |
| 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="1"
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 this study is to determine the accuracy and reproducibility of indigenously developed profile, smile, and dento-gingival coding and grading system for evaluating facial aesthetics. 100 participants (BDS students and practitioners, MDS (orthodontics) students and practitioners, 25 in each group) will be included in this study, and a PowerPoint presentation explaining various parameters of the PSD coding system will be explained and participants will be trained to use it. A template of 10 sets of photographs will be provided to these participants to analyze on the basis of an innovative PSD coding system and assign grading and scoring accordingly. The data obtained from each group will be analyzed statistically to evaluate the accuracy and reproducibility of an innovative PSD coding and grading system for facial aesthetics. |