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CTRI Number  CTRI/2022/02/040691 [Registered on: 28/02/2022] Trial Registered Prospectively
Last Modified On: 26/02/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of the influence of Facial height, facial width, interpupillary and intercommisural width over the size of buccal corridor on smiling :A cross-sectional study 
Scientific Title of Study   Influence of Facial height, facial width, interpupillary and intercommisural width over the size of buccal corridor on smiling. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajashri Kolte 
Designation  Professor and Guide 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  104, Department of Periodontics and Implantology VSPM Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071468  
Fax    
Email  drrajashrikolte@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajashri Kolte 
Designation  Professor and Guide 
Affiliation  VSPM Dental College and Research Centre, Nagpur 
Address  104, Department of Periodontics and Implantology VSPM Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071468  
Fax    
Email  drrajashrikolte@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay Kolte 
Designation  Professor and Head 
Affiliation  VSPM Dental College & Research Center, 
Address  104, Department of Periodontics and Implantology VSPM Dental College and Research Centre, Digdoh Hills, Hingna road Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax    
Email  drabhaypkolte@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna road Nagpur: 440019 Maharashtra India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Rajashri Kolte   VSPM Dental College and Research Centre, Nagpur  Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna road Nagpur: 440019
Nagpur
MAHARASHTRA 		 9011071468

drrajashrikolte@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPM Dental College and Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontally healthy males and females in the age range of 20-40 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients who are willing to participate and sign the informed consent for this clinical trial.
2. Males and females between the age group of 20-40 years.
3. Periodontally healthy patients as assessed with a Plaque Index (Silness & Loe 1964) and Gingival Index (Loe & Silness 1963) between the score of 0–1.
4. Patients with fully erupted, well-aligned maxillary Central Incisors, Lateral Incisors, and Canines without orthodontic anomaly 
 
ExclusionCriteria 
Details  1. Artificial crowns, fillings, attrition on anterior teeth.
2. Congenitally missing anterior tooth or teeth.
3. Pregnancy or a history of taking medications known to increase the risk of gingival hyperplasia.
4. Patients diagnosed with destructive periodontal disease or hypertrophy.
5. Patients with a history of any periodontal treatment in the past six months.
6. Malaligned or Orthodontically treated teeth.
7. Facial asymmetry 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate influence of Facial height, facial width, interpupillary and intercommisural width over the size of buccal corridor on smiling.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the anterior Facial height and width in the study population.
2. To assess interpupillary width in the study population.
3. To assess intercommisural width on smiling in the study population.
4. To assess the size of buccal corridor on smiling.
5. To evaluate and correlate the Facial height, facial width, interpupillary and intercommisural width and size of buccal corridor. 		 3months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study will be conducted to evaluate influence of Facial height, facial width, interpupillary and intercommisural width over the size of buccal corridor on smiling  in periodontally healthy males and females.

Total of 200 subjects with age range of 20-40 years including both male and female visiting the Department of Periodontics at VSPM Dental College and Research Centre, Nagpur will be recruited.

Study population will be divided into 2 groups:

Group I – 100 periodontally healthy males in the age range of 20-40 years.

Group II – 100 periodontally healthy females in the age range of 20-40 years.

 

A written informed consent will be taken from the patients who wish to enroll in the study. The study parameters of the patients will be assessed clinically and on digital photographs. Frontal view photographs of the subjects will be taken while smiling.

Determination of anterior Facial Height (FH):

For the measurement Total facial height (Tr-Me), the distance between Trichion (Tr)—the front line of the hair in the midline and menton (Me)—the lowest soft tissue point of the mandible , will be measured using a digital vernier caliper.

Determination of Facial width (FW):

Facial width will be measured as the bizygomatic width (the distance between the most prominent points on bilateral zygomatic arches)with the help of digital vernier caliper.

Determination of Interpupillary Width(IPW) in mm:

For the measurement of IPW, the midpoint of the pupils will be marked on a wooden tongue spatula which will be measured with a digital vernier caliper.

Determination of Inter-Commisural Width(ICOW) in mm:

The ICOW will be determined by measuring the maxillary lip vermilion from left commissure to right commissure with a digital vernier caliper.

Width of Buccal Corridor at smile: The right and the left buccal corridor spaces will be determined as the distance between the most buccal surface of the visible, posterior most maxillary tooth on either side and the right and the left commisures respectively.

 
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