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CTRI Number  CTRI/2023/11/059611 [Registered on: 07/11/2023] Trial Registered Prospectively
Last Modified On: 10/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive 
Study Design  Single Arm Study 
Public Title of Study   Examining the Effects of Smile Appearance on Indian Orthodontists and Patients: Studying How the Spaces between Teeth Affect Aesthetics 
Scientific Title of Study   EFFECT OF BUCCAL CORRIDORS ON SMILE ESTHETICS IN INDIAN ORTHODONTISTS AND ORTHODONTIC PATIENTS 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kunal Bhardwaj 
Designation  PG 3rd year 
Affiliation  Kalka Dental college and Hospital 
Address  Department of Orthodontics and dentofacial orthopedics,Kalka Dental College and Hospital Partapur,Meerut(U.P) 250103
Department of Orthodontics and dentofacial orthopedics,Kalka Dental College and Hospital Partapur,Meerut(U.P) 250103
Meerut
UTTAR PRADESH
250103
India 
Phone  8979587942  
Fax    
Email  bhardwajdrkunal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shipra Nagar 
Designation  HOD and Professor 
Affiliation  Kalka Dental college and Hospital 
Address  Dept. of Orthodontics Kalka Dental College and Hospital Partapur Meerut

Meerut
UTTAR PRADESH
250103
India 
Phone  9971822949  
Fax    
Email  shipray@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shipra Nagar 
Designation  HOD and Professor 
Affiliation  Kalka Dental college and Hospital 
Address  Dept. of Orthodontics Kalka Dental College and Hospital Partapur Meerut

Meerut
UTTAR PRADESH
250103
India 
Phone  9971822949  
Fax    
Email  shipray@yahoo.com  
 
Source of Monetary or Material Support  
Department of Orthodontics and Dentofacial Orthopedics,Kalka Dental College and Hospital Partapur,Meerut(U.P) 250103 
 
Primary Sponsor  
Name  Kalka Dental College  
Address  Room No 9 Department of Orthodontics and Dentofacial Orthopaedics Third Floor Partapur bypass Meerut 250103 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kunal Bhardwaj  Kalka Dental College & Hospital   Room no.9, Department of Orthodontics and Dentofacial Orthopedics
Meerut
UTTAR PRADESH 		 8979587942

bhardwajdrkunal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Kalka Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy individuals  
Patients  (1) ICD-10 Condition: K13||Other diseases of lip and oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  120 patients aging from 15-40 yrs
60 Orthodontists for evaluation
Aesthetic smile of patients for photographic evaluation

 
 
ExclusionCriteria 
Details  Patients with missing tooth
patients in old age group
Non- Aesthetic smile for photographic evaluation 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of buccal corridor on smile aesthetics from the perception of orthodontists & orthodontic patient  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
the purpose if this study is to evaluate the influence of size of buccal corridor on the assessment of attractive smile, aesthetics by indian orthodontists & orthodontic patients  at baseline 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "189"
Final Enrollment numbers achieved (India)="189" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) 25/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhardwajdrkunal@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-3000?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

This study discusses the significance of the face, particularly the mouth and teeth, in determining a person’s physical appearance. It emphasizes the need to understand the principles that govern the balance between teeth and soft tissue during a smile to effectively control the aesthetic effects of orthodontic treatment. The presence of bilateral spaces, known as negative spaces or buccal corridors, between the visible maxillary posterior teeth and the lip commissure during a smile is examined.

The opinions on the aesthetic value of buccal corridors vary among researchers. Some consider minimizing buccal corridors to be crucial for an attractive smile, while others believe they have minimal impact. These preferences may be influenced by regional and cultural differences. However, the influence of cultural and ethnic backgrounds on aesthetic perceptions is not well understood.

The perception of dental aesthetics by both laypeople and orthodontic patients is important when developing an orthodontic treatment plan. Orthodontists tend to be more critical of dental aesthetics, even for minor disharmonies, whereas trainee orthodontists rate overall dentofacial attractiveness higher than dental undergraduates and laypeople, according to a study.

The purpose of the mentioned study is to determine the threshold at which the size of buccal corridors starts to diminish dentofacial aesthetics in smiles. The assessment will involve Indian orthodontists and orthodontic patients.

 
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