| CTRI Number |
CTRI/2024/02/063364 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical evaluation of interrelationship between facial landmarks and dental midline |
|
Scientific Title of Study
|
A Clinical evaluation of interrelationship between facial landmarks and dental midline |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Unnati Menghani |
| Designation |
Post Graduate Student |
| Affiliation |
FACULTY OF DENTAL SCIENCE DHARAMSIHN DESAI UNIVERSITY, NADIAD GUJARAT |
| Address |
Faculty of Dental Science, DDU, Nadiad
Department of Prosthodontics, Crown and Bridgework and Oral Implantology
Ground floor Post Graduate Clinic
Kheda
GUJARAT
387001
India |
| Phone |
9924662628 |
| Fax |
|
| Email |
unnaatimenghani1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tanvi Goyal |
| Designation |
Lecturer |
| Affiliation |
FACULTY OF DENTAL SCIENCE DHARAMSIHN DESAI UNIVERSITY, NADIAD GUJARAT |
| Address |
Faculty of Dental Science, DDU, Nadiad
Department of Prosthodontics, Crown and Bridgework and Oral Implantology Ground Floor Post Graduate Clinic
Dharamsinh Desai University college road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09429319196 |
| Fax |
|
| Email |
tanvigoyal.s92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Unnati Menghani |
| Designation |
Post Graduate Student |
| Affiliation |
FACULTY OF DENTAL SCIENCE DHARAMSIHN DESAI UNIVERSITY, NADIAD GUJARAT |
| Address |
Faculty of Dental Science, DDU, Nadiad
Department of Prosthodontics, Crown and Bridgework and Oral Implantology Ground Floor
Post Graduate Clinic
Kheda
GUJARAT
387001
India |
| Phone |
9924662628 |
| Fax |
|
| Email |
unnaatimenghani1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Science, DDU, Nadiad |
|
|
Primary Sponsor
|
| Name |
Unnati Menghani |
| Address |
Faculty of Dental Science, DDU, Nadiad
Department of Prosthodontics, Crown and Bridgework and Oral Implantology
Ground Floor Post Graduate Clinics |
| 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 UNNATI MENGHANI |
FACULTY OF DENTAL SCIENECE |
Dharamsinh Desai University
Faculty Of Dental Science
Department of Prosthodontics, Crown and Bridgework and Oral Implantology Ground floor
Nadiad
Kheda
GUJARAT |
9924662628
unnaatimenghani1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committeee of Faculty of Dental Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INDIVIDUALS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
The age range of 21-45 years with natural permanent dentition, with all permanent teeth present. |
|
| ExclusionCriteria |
| Details |
History of congenital or acquired condition affecting facial form and appearance
History of orthodontic treatment
Missing maxillary anterior teeth
Any restorations in maxillary anterior teeth
Interdental spacing or overlapping of central incisors
Severe malocclusion
Ophthalmic asymmetry
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of midfacial landmarks to dental midline |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correltion of marked facial landmarks to dental midline |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/03/2024 |
| 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 study titled "A Clinical Evaluation of Interrelationship Between Facial Landmarks and Dental Midline"will be conducted at the Department of Prosthodontics, Crown and Bridgework, and Oral Implantology, Faculty of Dental Science, Dharamsinh Desai University, Nadiad. The research will involve the utilization of advanced equipment, such as the Sony Alpha ILCE-ME digital SRL camera with a macro lens, a Godox TT520 flash, and a Carestream CS 8100SC lateral cephalogram. The photographs of the subjects aged 21-45 with all natural permanent dentition will captured. Digital image analysis, to be performed using Adobe Photoshop, will focus on anatomical landmarks and the construction of an "Esthetic Frame" in the software to evaluate their interrelation with the dental midline. Statistical analysis, using one-sample t-tests, will be anticipated to reveal significant differences between the mean ratios of anatomical landmarks and the dental midline. The study aims to provide a hierarchy of midline facial landmarks for dental midline determination, emphasizing the importance of understanding these relationships in aesthetic dentistry. |