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CTRI Number  CTRI/2026/03/105104 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 01/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparison of different growth patterns and Collum angle using two dimensional radiographs and its correlation with differnt type of lower lip position. 
Scientific Title of Study   Comparison of Collum angle using cephalometries in different growth patterns and correlation with variations of lower lip position an in vivo study 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHARUN SHANKAR N 
Designation  MDS STUDENT 
Affiliation  KALKA DENTAL COLLEGE 
Address  PARTAPUR MEERUT

Meerut
UTTAR PRADESH
250103
India 
Phone  8086311423  
Fax    
Email  sharunshiva95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SHIPRA NAGAR 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT 
Affiliation  KALKA DENTAL COLLEGE 
Address  KALKA DENTAL COLLEGE MEERUT

Meerut
UTTAR PRADESH
250103
India 
Phone  9971822949  
Fax    
Email  shipray@yahoo.com  
 
Details of Contact Person
Public Query  
Name  SHIPRA NAGAR 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT 
Affiliation  KALKA DENTAL COLLEGE 
Address  KALKA DENTAL COLLEGE MEERUT

Meerut
UTTAR PRADESH
250103
India 
Phone  9971822949  
Fax    
Email  shipray@yahoo.com  
 
Source of Monetary or Material Support  
Kalka Dental College & Hospital Partapur Uttar Pradesh 250103, India 
 
Primary Sponsor  
Name  SHARUN SHANKAR N 
Address  KALKA DENTAL COLLEGE MEERUT 
Type of Sponsor  Other [Self] 
 
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 
SHARUN SHANKAR N  KALKA DENTAL COLLEGE  By Pass, near Partapur Flyover,RoyalKunj,Partapur,Meerut,Uttar Pradesh 250002, India Department of orthodontics and dentofacial orthopedics. Room no.9 ,2 n d floor.
Meerut
UTTAR PRADESH 		 8086311423

sharunshiva95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  WITH DENTAL MALOCCULSION 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Collum Angle, Growth patterns and Lowerlip Position.  The collum angle (CA) refers to the angle formed between the long axis of the crown and the long axis of the root of a tooth, most commonly assessed in the maxillary central incisor on lateral cephalometric radiographs. It represents the degree of crown–root angulation and is an important morphological parameter in orthodontics because even small variations can significantly influence tooth movement, torque expression, and stress distribution in the periodontal ligament. The collum angle is closely related to facial growth patterns. In individuals with vertical growth patterns (hyperdivergent cases), the maxillary incisors often exhibit greater crown–root angulation, resulting in a higher collum angle, whereas horizontal growth patterns (hypodivergent cases) tend to show smaller values. This variation is thought to be influenced by functional adaptation and dentoalveolar compensation. Furthermore, the collum angle has been associated with lower lip position. When the lower lip contacts different vertical thirds of the maxillary central incisor, it can exert varying pressure on the crown, potentially influencing its inclination and the crown–root relationship. For example, contact at the middle third has been associated with higher collum angle values compared to incisal or cervical third contact. Thus, the collum angle serves as an important link between tooth morphology, skeletal growth pattern, and soft tissue dynamics, and it has significant implications in diagnosis, treatment planning, and biomechanical control during orthodontic therapy. 
Intervention  Lateral Cephalogram  The Collum angle will be measured by drawing two lines on the X-ray. The first line is drawn from the tip of the root (radiographic apex) to the center of the cementoenamel junction, which is the area where the crown meets the root. The second line is drawn along the long axis of the crown and extended downward toward the root. The angle formed between these two lines is recorded as the Collum angle 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patient of age range 13-30 years.
2.Normal growth and development.

 
 
ExclusionCriteria 
Details  1.History of orthodontic treatment
2.History of maxillofacial or plastic surgery
3.Subjects with craniofacial trauma that may hamper the growth.
4.Patients with upper or lower central incisor missing.
5.Patients with upper or lower central prosthetic crown or veneers.
6.Inferior image quality
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
CORREALTION OF COLLUM ANGLE WITH DIFFERENT GROWTH PATTENS
 		 Base line before start of the treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
CORRELATION OF COLLUM ANGLE WITH VARIARTION OF LOWERLIP POSITION  Base line before start of the treatment. 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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   Phase 1 
Date of First Enrollment (India)   21/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/03/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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 - 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

  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 [sharunshiva95@gmail.com].

  6. For how long will this data be available start date provided 25-03-2025 and end date provided 26-11-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to compare the collum angle across different growth patterns (horizontal, average, vertical) using cephalometrics and analyze its correlation with lower lip position variations, including the lower lip line and contact with the central incisor tip. The null hypothesis assumes no differences in collum angle between growth patterns and no relationships with lower lip position or contact 
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