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CTRI Number  CTRI/2022/02/040625 [Registered on: 25/02/2022] Trial Registered Prospectively
Last Modified On: 24/02/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   This cross sectional study evaluates the association of facial height with dimensions of maxillary anterior teeth and shape of crown in periodontally healthy population - a gender based evaluation. 
Scientific Title of Study   Association of facial height with dimensions of maxillary anterior teeth and shape of crown in periodontally healthy population - a gender based evaluation. 
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 Guide, HOD  
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  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  Dr Rajashri Kolte 
Address  Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna road Nagpur: 440019 Maharashtra India 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
none   
 
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  Department of Periodontics and Implantology  104 Department of Periodontics and Implantology VSPM Dental College and Research Centre, Digdoh Hills, Hingna Road Nagpur 440019 Maharashtra India
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 
Intervention  NIL  NIL 
 
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. Healthy gingiva 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. Crowding or spacing, translocated /tilted teeth malaligned or orthodontically treated, congenitally missing anterior teeth.
3. Evidence of incomplete passive eruption.
4. Facial asymmetry.
5. Pregnancy or a history of taking medications known to increase the risk of gingival hyperplasia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and correlate facial height, dimensions of anterior teeth, with shape of crown with facial esthetics in periodontally healthy males and females.  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess anterior facial height, the height and width of maxillary anterior teeth, contact surface height, crown width to length ratio of maxillary anterior teeth, shape of crowns in the maxillary anterior region of the jaw in the study population and to correlate facial height, height, and width of maxillary anterior teeth, contact surface height, crown width to length ratio, and shape of a crown in periodontally healthy males and females.  3 months 
 
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 and correlate facial height, dimensions of anterior teeth, with the shape of a crown with facial esthetics in periodontally healthy males & females.

A total of 200 subjects with an age range of 20-40 years including both males and females visiting the Department of Periodontics at VSPM Dental College and research center Nagpur will be recruited. Study participants will be divided into 2 groups Group I – Will comprise of periodontally and systemically healthy 100 males within an age range of 20-40 years.

Group II – Will comprise of periodontally and systemically healthy 100 females within an age range of 20-40 years.

A brief description of the entire procedure will be given to every patient before starting the procedure.  For all subjects following periodontal parameters will be recorded:

1.      Plaque index (Silness and Loe 1964)

2.      Gingival index (Loe and Silness 1963)

The study parameters of the patients will be assessed clinically and on digital photographs. Frontal view photographs of the subjects that will be fixed in the Frankfort horizontal plane. For the measurement of total facial height (Tr-Me): naso-menton length, These landmarks will be trichion (Tr)—the front line of the hair in the midline and menton (Me)—the lowest soft tissue point of the mandible will be the two-point used to determine the anterior facial height that will be measured with a digital vernier caliper. Crown width will be measured at the junction between the cervical and middle section of the crown. The crown height will be assessed by measuring the distance between the most apical portion of the facial gingival margin and the incisal edge of the crown, parallel to the long axis of the tooth using digital photographs. To determine contact surface height the length of the contact surface will be measured from the most apical portion of the contact area to the most incisal portion on the mesial surface of the central incisor using digital photographs. The value of crown width and length of maxillary anterior teeth will be determined by dividing the values. the shape of crowns in the maxillary anterior region of the jaw will be determined it can be triangular crown shape, tapered squarish crown shape, squarish crown shape.

And then correlation among facial height, height, and width of maxillary anterior teeth, contact surface height, crown width to length ratio, and shape of a crown in periodontally healthy males & females will be done. 
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