FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/066770 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 02/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Submandibular Gland Fossa depth evaluation by CBCT 
Scientific Title of Study   “Cone Beam Computed Tomographic Evaluation of Submandibular Gland Fossa Depth and its Relation to Inferior Alveolar Nerve Canal: 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  K B A Kader 
Designation  Resident Post Graduate 
Affiliation  Institute Of Dental Sciences, Bareilly 
Address  15, Dept of Oral medicine and Radiology, Institute Of dental Sciences, Bareilly

Bareilly
UTTAR PRADESH
243001
India 
Phone  9679380416  
Fax    
Email  kbakaderdoc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashish Aggarwal 
Designation  Professor and Head Of Department 
Affiliation  Institute Of Dental Sciences, Bareilly  
Address  16,Dept Of Oral Medicine And Radiology, Institute Of dental Sciences

Bareilly
UTTAR PRADESH
243001
India 
Phone  9358353566  
Fax    
Email  drashishagg01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ashish Aggarwal 
Designation  Professor and Head Of Department 
Affiliation  Institute Of Dental Sciences, Bareilly  
Address  16,Dept Of Oral Medicine And Radiology, Institute Of dental Sciences

Bareilly
UTTAR PRADESH
243001
India 
Phone  9358353566  
Fax    
Email  drashishagg01@gmail.com  
 
Source of Monetary or Material Support  
Institute Of dental Sciences, Bareilly 
 
Primary Sponsor  
Name  K B A Kader 
Address  15, Department Of Oral medicine and radiology,Institute Of dental Sciences, Bareilly 
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 K B A Kader  Institute Of Dental Sciences, Bareilly  15, Dept Of oral medicine and radiology, Institute Of Dental Sciences, Bareilly
Bareilly
UTTAR PRADESH 		 9679380416

kbakaderdoc@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  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with complete or partially edentulous posterior mandibles. 
 
ExclusionCriteria 
Details  Any congenital and developmental disorders.
Abnormal morphology resulting from trauma. Pathologic conditions affecting the region of interest. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Depth of Submandibular gland fossa depth and its relation to inferior alveolar nerve  5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
variations in depth of submandibular gland fossa in differnt genders   5 weeks 
 
Target Sample Size   Total Sample Size="116"
Sample Size from India="116" 
Final Enrollment numbers achieved (Total)= "161"
Final Enrollment numbers achieved (India)="161" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/06/2024 
Date of Study Completion (India) 01/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kbakaderdoc@gmail.com].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 01-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Panoramic views and other extraoral radiographs, for instance periapical radiographs, are beneficial tools for assessing the dental implant site, but they don’t provide abundant data.7 Additional techniques include intraoral palpation of the region and dental casts, both of which lack helpful information about the morphology and diversity of the anatomy.9 Thus, there is necessity for a reliable method that is universally accepted. The threedimensional nature of cone beam computed tomography (CBCT) is highly efficient in assessing the SGF with lesser patient dose as paralleled to computed tomography (CT). CBCT serves as a promising tool in judgement of the anatomical structures comprising SGF prior to any clinical procedure.10 There is paucity of data relating to the deepness of SGF hence, the present study will be conducted to gauge the concavity depth at the lingual mandibular depression of the SG and its position according to age, sex, and the side of the mandible. 
Close