| CTRI Number |
CTRI/2019/02/017866 [Registered on: 28/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
In Vitro questionnaire study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the facial attractiveness of Indian facial profiles and is scored by 3 groups of participants. |
|
Scientific Title of Study
|
Esthetic preferences of orthodontists, general dentists, and laypersons for Indian facial profiles. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Harshini Reddy |
| Designation |
MDS Post graduate resident |
| Affiliation |
Manipal University |
| Address |
Room No-7,Department of Orthodontics and Dentofacial Orthopedics,Manipal college of dental sciences,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8464075631 |
| Fax |
|
| Email |
harshu.padigela@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritesh Singla |
| Designation |
Associate Professor |
| Affiliation |
Manipal University |
| Address |
Room No-7,Department of Orthodontics and Dentofacial Orthopaedics,Manipal college of Dental Sciences,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8464075631 |
| Fax |
|
| Email |
ritesh.singla@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
P Harshini Reddy |
| Designation |
MDS Post graduate resident |
| Affiliation |
Manipal University |
| Address |
Room No-7,Department Of Orthodontics and Dentofacial Orthopedics,Manipal college of dental sciences,Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8464075631 |
| Fax |
|
| Email |
harshu.padigela@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental sciences |
|
|
Primary Sponsor
|
| Name |
P Harshini Reddy |
| Address |
Room no-7, Manipal college of dental sciences |
| 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 |
| P Harshini Reddy |
Manipal college of dental sciences |
Room no-7,Department Of Orthodontics and Dentofacial Orthopaedics,Manipal college of dental sciences, Manipal.
Udupi
KARNATAKA |
8464075631
harshu.padigela@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 |
 Exclusion criteria:
• Class II and Class III
malocclusions
• Congenital deformities
• Facial anomalies
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
orthodontists, general dentists, and laypersons |
• One profile photograph and one X-ray is taken, and the photograph is changed to the required measurements to get different facial profiles in the computer.
• The changed photographs are printed and are given to 18 orthodontists, 18 general dentists and 18 laypersons to assess facial attractiveness so that interobserver reliability can be evaluated
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria –
1) To include skeletal and dental class I
relationship with well aligned arches
2) Age group of samples between 15-28 yrs.
3) Age group of observers between 18-50 yrs.
4) Well balanced face
4) Normal eyes, lips, and nose
5) Z- angle: 71°- 89°
6) Layperson who is not into medical or dental
profession
7) English speaking participants are only taken.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1) Class II and Class III malocclusions
2) Congenital deformities
3) Facial anomalies
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| interobserver reliability among orthodontists, general dentists and laypersons |
18-50yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| interobserver reliability among orthodontists, general dentists and laypersons |
18-50yrs |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/03/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
. References:
1. Farhad B. Naini, Martyn T. Cobourne, Fraser McDonald and David Wertheim the aesthetic impact of upper lip inclination in orthodontics and orthognathic surgery. Eur J Orthod. 2015; 37: 81–86.
2. Charles J Burnstone; Lip posture and its significance in treatment planning; Am J Orthod 1967; 53: 262-284.
3. Young-Chel Park and Charles J Burnstone. Soft-tissue profile fallacies of hard-tissue standards in treatment planning. Am J Orthod Dentofac Orthop. 1986; 90: 52-62.
4. Franklin D lo, W Stuart Hunter. Changes in nasolabial angle related to maxillary incisor retraction; Am J Orthod. 1982; 82:384-391.
5. Louis Alberto. Soft tissue profile changes after orthodontic treatment with four premolars extracted. Angle Orthod. 1994;64:31-42.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
- One profile photograph and one X-ray of the two study participants are taken.
- The x-ray and and the photograph are studied carefully.
- Then the photograph is changed to the required measurements to get the different facial profiles on the computer.
- The changed photographs are printed and given to 20 orthodontists, 20 general dentists, 20 laypersons to assess the facial attractiveness so that interobserver reliability can be compared.
|