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CTRI Number  CTRI/2025/03/083059 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To check proximity between incisive canal and upper front teeth after moving them backwards using CBCT 
Scientific Title of Study   Evaluation of Proximity Between Incisive Canal and Maxillary Central Incisor After Anterior Retraction: A CBCT Study 
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 AJAY K 
Designation  POST GRADUATE STUDENT 
Affiliation  SURENDRA DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Surendra dental college ,His highness garden,sadhulshahar road,sriganganagar

Ganganagar
RAJASTHAN
335001
India 
Phone  9526504158  
Fax    
Email  ajaykuttu45@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr EENAL BHAMBRI 
Designation  PROFESSOR AND HEAD 
Affiliation  SURENDRA DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Surendra dental college ,His highness garden,sadhulshahar road,sriganganagar

Ganganagar
RAJASTHAN
335001
India 
Phone  8769829700  
Fax    
Email  dreenal700@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr EENAL BHAMBRI 
Designation  PROFESSOR AND HEAD 
Affiliation  SURENDRA DENTAL COLLEGE AND RESEARCH INSTITUTE 
Address  Surendra dental college ,His highness garden,sadhulshahar road,sriganganagar

Ganganagar
RAJASTHAN
335001
India 
Phone  8769829700  
Fax    
Email  dreenal700@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthodontics and Dentofacial Orthopaedics, Room No. 3, A Block, Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan, 335001 
 
Primary Sponsor  
Name  Dr Ajay K 
Address  Surendera dental college and research institute,his higness garden,powerhouse road,sriganganagar,Rajasthan,335001 
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 
Dr Ajay K  Surendera dental college and research institute  Department of Orthodontics and Dentofacial Orthopaedics, Room No. 3, A Block, Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan, 335001
Ganganagar
RAJASTHAN 
9526504158

ajaykuttu45@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee SDCRI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Angles class II div I malocclusion 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.Patients with bimaxillary dentoalveolar protrusion or Angle’s class II division 1 malocclusion requiring extraction of 1st premolar.
2.Moderate to maximum anchorage cases will be considered.
3.The removal of bilateral maxillary first premolars during the orthodontic treatment followed by en masse retraction.
4.No history of trauma to the maxillary and mandibular anterior teeth 
 
ExclusionCriteria 
Details  1.Root length (the distance from the cementoenamel junction to apex) of maxillary incisors was less than 9 mm in T0 CBCT
2.Low CBCT image quality the cortical bone and root could not be defined accurately. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to assess if lowerly positioned incisive canal will contact upper incisor roots after retraction  data will be collected at baseline and after 10 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate whether contact between the upper incisor root & the incisive canal can result in root resorption.  data will be collected at baseline & after 10 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/06/2025 
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="2"
Months="1"
Days="2" 
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  

AIM:To analyze the effect of upper anterior teeth retraction on the root proximity to the incisive canal (IC).

OBJECTIVES:.1.To evaluate the effects of retraction on the proximity of incisive canal and roots of anterior teeth using CBCT 

2.To assess the changes in the incisive canal (IC) and its relationship with the upper first incisor (U1) by measuring IC height, IC width, and U1-IC distances at multiple levels.

 3.To explore the risk factors for contact between the incisive canal (IC) and upper central incisors (U1) and to evaluate the relationship between contact and root resorption.

 4.To ensure consistency and accuracy in measurements by using a standardized method of evaluating CBCT data, with pre-retraction and post-retraction data compared for each patient, accounting for factors such as head position and anatomical landmarks (e.g., ANS, PNS).

Methodology

CBCT scan will be obtained for maxillary anteriors including canine at 8x8 cm field of view, 90 KV, 8 MVA, 11.4 second scan time and 200 micron voxel size Veraview X 800 model  machineThey will be taken at two time periods

a) before treatment

b) after retraction

Further which will be analyzed using i- Dixel software, ensuring the standardization of head position.Axial and sagittal sections are collected from each sample. Axial sections will be aligned parallel to the Frankfort plane, while sagittal sections will be made vertical to the axial plane and parallel to the connection between the anterior nasal spine (ANS) and posterior nasal spine (PNS). Coronal sections will then be made perpendicular to both the axial and sagittal sections

Several measurements will be conducted using the 3D measurement function of i-Dixel software:

 

Incisive Canal (IC) Height: Will be defined as the vertical distance between the incisive foramen plane and the cemento-enamel junction (CEJ). The incisive foramen plane will be the horizontal plane passing through the lowest point of the buccal wall of the IC

IC Width: Will be defined as the transverse distance parallel to coronal sections between the most distal points of the IC. IC width will be measured at three horizontal levels in the sagittal view, ensuring consistency by recording the vertical distance between each level and the horizontal line passing through the ANS in pre-retraction images and transferring these levels to post-retraction images. The average of these three levels will be calculated for each patient.

U1-IC Distances: These will be measured at the same three horizontal levels and will be defined as the anteroposterior distance from the most mesial point of the upper first incisor (U1) to the cortical plate of the IC. Measurements will be recorded separately for the left and right sides. 

U1-IC Decrease: Will be defined as the difference between the pre-treatment and post-treatment U1-IC distances. If the root comes into contact with or invades the IC, the distance will be recorded as 0 mm.

Root Length Measurement: The root length of both left and right U1 before and after retraction will be measured in the sagittal view.

Inclination change: Measurements of the inclination  of U1   before and after retraction will bemeasured in the sagittal view.inclination will be measured between tooth axis and H line

Horizontal retraction distancehorizontal retraction distance (HRD) of  U1  the perpendicular distance between the maxillary incisor edge and V-line 

Vertical dental position:vertical position of tooth is  the perpendicular distance between the maxillary incisor edgeand the H-line

 
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