| CTRI Number |
CTRI/2024/01/061620 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of dental features in smile of various patients of different growth pattern. |
|
Scientific Title of Study
|
Assessment of esthetic smile components in patients of skeletal Class II vertical and horizontal growth pattern as compared with Class I cases. |
| 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 Ruchika Pandey |
| Designation |
Postgraduate |
| Affiliation |
Datta Meghe Institute Higher Education and Research |
| Address |
Dept. no. 102, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College, Datta Meghe Institute Higher Education and Research, Sawangi(M), Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8839970153 |
| Fax |
|
| Email |
ruchika938pandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjit Kamble |
| Designation |
Head of Department |
| Affiliation |
Datta Meghe Institute Higher Education and Research |
| Address |
Dept. no. 102, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College, Datta Meghe Institute Higher Education and Research, Sawangi(M), Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7440701543 |
| Fax |
|
| Email |
ranjitkamble2506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchika Pandey |
| Designation |
Postgraduate |
| Affiliation |
Datta Meghe Institute Higher Education and Research a |
| Address |
Dept. no. 102, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College, Datta Meghe Institute Higher Education and Research, Sawangi(M), Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8839970153 |
| Fax |
|
| Email |
ruchika938pandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. no. 102, Department of Orthodontics and Dentofacial Orthopedics, Sharad Pawar Dental College, Datta Meghe Institute Higher Education and Research, Sawangi(M), Wardha, Maharashtra, India,(442001) |
|
|
Primary Sponsor
|
| Name |
Dr. Ruchika Pandey |
| Address |
Near Priya Nursery Bank Colony Siddharth Nagar Satna M.P. |
| Type of Sponsor |
Other [Individual] |
|
|
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 Ruchika Pandey |
Sharad Pawar Dental College and Hospital |
Dept. no. 102, Department of Orthodontics and Dentofacial Orthopedics, Datta Meghe Institute Higher Education and Research, Sawangi(M), Wardha, Maharashtra, India,(442001)
Wardha
MAHARASHTRA |
8839970153
ruchika938pandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DMIHER DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age range of 14 to 30 years
Skeletal Class I and Class II patients.
Presence of all permanent teeth except 3rd molars.
Patients with symmetrical face with no history of trauma.
|
|
| ExclusionCriteria |
| Details |
Patients with Class III molar or canine relationship
Patients having mixed Dentition
Previous/ Undergoing orthodontic treatment
Cleft lip or palate
Absent/ Missing teeth
Patients having dentofacial deformities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Even with the Class I malocclusion, the components of balanced smile will lie in the normal range while it will vary with Class II vertical and horizontal cases. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will aim to improve both the function and aesthetics of the smile. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
05/02/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
ABSTRACT INTRODUCTION: In orthodontics, the study and enhancement of the smile play a central role in achieving both aesthetic and functional goals. A beautiful and harmonious smile not only contributes to an individual’s self-confidence but also reflects the proper alignment and health of the teeth and jaws. A balanced smile is a key aspect of facial aesthetics and oral health, encompassing various components that contribute to a harmonious and pleasing appearance. The assessment of these components plays a crucial role in orthodontics and cosmetic dentistry, guiding treatment plans to achieve optimal results. The eight primary components of a balanced smile serve as essential criteria in evaluating both the aesthetic and functional aspects of the teeth and surrounding structures.
METHODOLOGY: Patients will be segregated into into 3 groups 15 in each: Skeletal Class I, Class II Vertical and Class II Horizontal malocclusion. On each subject’s sheet, the molar relation and any current malocclusions will be documented. Following these preparations, each subject will be told to unwind in order to get the frontal rest position picture, then grin (like you’re saying hello) in order to get the social smile picture. Then, using the software’s Unit tool, measurements will be calibrated and 8 components of balanced smile will be determined. EXPECTED RESULT: The 8 components of balanced smile in Class I malocclusion will fall within normal range when compared to Class II vertical and horizontal cases. The goal is typically to achieve a harmonious and aesthetically pleasing smile while also addressing functional issues. CONCLUSION: In conclusion, the eight components of a balanced smile play a crucial role in assessing and addressing malocclusions, such as Class 2 and Class 1. Achieving an optimal smile involves considerations such as overjet and overbite, midline alignment, gum display, facial symmetry, lip support, and functional bite. KEYWORDS: Smile, Smile design, Balanced smile, Components of smile, Class I Malocclusion, Class II malocclusion |