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CTRI Number  CTRI/2025/07/090551 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study to Assess the Accuracy of STOP-BANG and Epworth Sleepiness Questionnaires in Identifying Patients with Suspected Upper Airway Obstruction Using CBCT Airway Volume Analysis in Adults 
Scientific Title of Study   To Assess the Co-relation of STOP-BANG and Epworth Sleepiness Questionnaire in Predicting Cases with Upper Airway Insufficiency for Adult Population as Compared to Airway Volume on CBCT: A Retrospective Observational 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 Harshal Burile  
Designation  Post graduate student  
Affiliation  Ranjeet deshmukh dental college and Research Centre,nagpur  
Address  room number 110 department of orthodontics and dentofacial orthopaedics ranjeet deshmukh dental college and research centre nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  7972570614  
Fax    
Email  07harsh.burile@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Himija Karia  
Designation   
Affiliation  ranjeet deshmukh dental college and Research Centre,nagpur  
Address  room number 110, department of orthodontics and dentofacial orthopaedics, ranjeet deshmukh dental college and research centre

Nagpur
MAHARASHTRA
440019
India 
Phone  7709454893  
Fax    
Email  drhimijakaria@vspmdcrc.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Harshal Burile  
Designation  Post graduate student  
Affiliation  Ranjeet deshmukh dental college and Research Centre,nagpur  
Address  room number 110, department of orthodontics and dentofacial orthopaedics , ranjeet deshmukh dental college and research centre

Nagpur
MAHARASHTRA
440019
India 
Phone  7972570614  
Fax    
Email  07harsh.burile@gmail.com  
 
Source of Monetary or Material Support  
Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
 
Primary Sponsor  
Name  Dr harshal burile  
Address  110 department of orthodontics and dentofacial orthopaedics , 1st floor , ranjeet deshmukh dental college and research centre ,nagpur  
Type of Sponsor  Other [self supported ] 
 
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 
Harshal Burile  ranjeet deshmukh dental college and research centre   room number 110 department of orthodontics and dentofacial orthopaedics
Nagpur
MAHARASHTRA 		 07972570614

07harsh.burile@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE OF RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE NAGPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q349||Congenital malformation of respiratory 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 who consent to participate in study .
Subjects above 18 years of age.
CBCT of those subjects who have been advised full skull CBCT for orthodontic diagnosis and treatment planning within last 6 month.
 
 
ExclusionCriteria 
Details  Patients with history of treatment for OSA with PAP therapy or Mandibular advancement devices.
History of surgery or trauma to mandible.
Patients who do not volunteer for the participation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine whether there is a statistically significant correlation between the STOP-BANG and Epworth Sleepiness Questionnaire scores and the airway volume measured on CBCT scans in adult patients.
This primary outcome will help answer:
Are questionnaires alone reliable for screening airway issues?
reduce dependence on expensive imaging like PSG if questionnaires are proven valid?

How well do subjective symptoms (questionnaire scores) match objective measurements (airway volume)? 		 cbct data will be obtained from the archieves of the radiology department once  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the sensitivity and specificity of STOP-BANG and Epworth questionnaires in detecting reduced airway volume on CBCT.  A single time point at which the CBCT scan was taken and STOP-BANG and Epworth Sleepiness scores were recorded for each patient. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   20/07/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
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   The study includes 42 adult patients who had already undergone CBCT scans and were administered STOP-BANG and Epworth questionnaires during their orthodontic consultation. Data is being (or has been) collected from existing records. 
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