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CTRI Number  CTRI/2024/05/066836 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 03/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Inferior alveolar nerve canal orientation in mandibular posterior region using CBCT 
Scientific Title of Study   Assessment of Inferior Alveolar Nerve canal orientation in Mandibular Posterior Region using Cone Beam Computed Tomography – An Analytical 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  Arifa Naaz 
Designation  Resident Post Graduate 
Affiliation  Institute of Dental Sciences Bareilly 
Address  15, Department of Oral Medicine and Radiology, Institute of Dental Sciences, Bareilly

Bareilly
UTTAR PRADESH
243001
India 
Phone  7060016813  
Fax    
Email  arifanaaz60@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitin Upadhyay 
Designation  Professor 
Affiliation  Institute of Dental Sciences Bareilly 
Address  16, Department of Oral Medicine and Radiology, Institute of Dental Sciences, Bareilly

Bareilly
UTTAR PRADESH
243001
India 
Phone  9719347473  
Fax    
Email  dr.nitinupadhyay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nitin Upadhyay 
Designation  Professor 
Affiliation  Institute of Dental Sciences Bareilly 
Address  16, Department of Oral Medicine and Radiology, Institute of Dental Sciences, Bareilly


UTTAR PRADESH
243001
India 
Phone  9719347473  
Fax    
Email  dr.nitinupadhyay@gmail.com  
 
Source of Monetary or Material Support  
Institute Of Dental Sciences, Bareilly 
 
Primary Sponsor  
Name  Dr Arifa Naaz 
Address  Room no. 15, Department of Oral Medicine and Radiology, Institute of Dental Sciences, Bareilly 
Type of Sponsor  Private medical college 
 
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 Arifa Naaz  Institute Of Dental sciences, Bareilly  15, dept of oral medicine and radiology, Institute Of Dental Sciences, Bareilly
Bareilly
UTTAR PRADESH 		 7060016813

arifanaaz60@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IDS,Bareilly ,U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Observational   Single Arm 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  CBCT images of both males and females above 18 years.
 
 
ExclusionCriteria 
Details  History of trauma, pathology, or surgical intervention like orthognathic surgery procedures in mandible.
Any syndromes and congenital disorders affecting jaw 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Orientation of inferior alveolar nerve canal in mandibular posterior region  zero day 
 
Secondary Outcome  
Outcome  TimePoints 
buccolingual orientation of inferior alveolar nerve canal ,buccal and lingal bone thickness  zero day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 03/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/04/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 [arifanaaz60@gmail.com].

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 01-01-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  
The most often damaged nerve is the IAN (64.4%), followed by the lingual nerve (28.8%). Moreover, up to 40% of incidences of IAN injuries are implant related. During the procedure of implant insertion, intrusion into the IAN canal may result in total anaesthesia or paraesthesia, increased chances of hemorrhage, and impairment of typical functions, such as speech and eating. 7 Any stage of dental implant surgery, including the administration of local anaesthesia, incision, reflection of soft tissue, implant osteotomy, implant insertion, and suturing after surgery, might result in an IAN damage. 8 It is necessary to have in-depth knowledge about the location and path of IAN canal prior to any surgical intervention to minimalize the peril of IAN injury. Therefore, by doing pre-operative radiographic assessment, the clinician can provide patients with the necessary information regarding the surgical procedure inform them about the possibility of potential complications.9 With this background, the present study will be directed to assess the buccolingual orientation of IAN canal in posterior mandibular region using CBCT.
 
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