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CTRI Number  CTRI/2025/02/080816 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Dentistry 
Study Design  Other 
Public Title of Study   To measure upper airway dimension in reduced mouth opening patient using x-ray 
Scientific Title of Study   Evaluation of upper airway dimensions using cone-beam computed tomography in Oral submucous fibrosis patients-A cross-sectional 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 Pavithra G 
Designation  Post graduate student 
Affiliation  KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department of Oral Medicine and Radiology KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9677533351  
Fax    
Email  paviviji75@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pavithra G 
Designation  Post graduate student 
Affiliation  KLE Vishwanath Katti Institute of Dental Sciences 
Address  Department of Oral Medicine and Radiology KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9677533351  
Fax    
Email  paviviji75@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Zameera Naik 
Designation  Professor 
Affiliation  KLE Vishwanath Katti Institute of Dental Sciences  
Address  Department of Oral Medicine and Radiology KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448854710  
Fax    
Email  drznaik@gmail.com  
 
Source of Monetary or Material Support  
KLE Vishwanath Katti Institute of Dental Sciences, BELAGAVI KARNATAKA 590010  
 
Primary Sponsor  
Name  Dr Pavithra G 
Address  Department of Oral Medicine and Radiology KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar  
Type of Sponsor  Other [Self funded] 
 
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 Pavithra G  KLE VK Institute of dental sciences  Department of Oral Medicine and Radiology, Department Number 1, Ground floor, KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA 
9677533351

paviviji75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K135||Oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cone Beam Computed Tomography  After diagnosing the oral submucous fibrosis patients, Cone Beam computed Tomography (CBCT) will be taken for analysing upper airway dimensions.CBCT will be taken on the day of diagnosing the patient( one time) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  CBCT scans display a sufficient field of view covering the nasopharynx, oropharynx, and appropriate tongue position. OSMF patients who require full mouth scan or cone beam computed tomography radiographs for endodontic, orthodontic, ENT, or oral surgery purposes and who provide consent for the study will be included in the study 
 
ExclusionCriteria 
Details  1. Patients without oral submucous fibrosis, with generalized degenerative joint disease or with other pathologies like clefts, associated malignancy, with parafunctional habits and pregnant women, edentulous patients, and significant mandibular retrognathia or prognathia
2. Improper CBCT imaging displaying a posterior positioning of the tongue which may affect measurements will be excluded from the study
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Upper airway dimensions and velopharyngeal incompetency will be assessed to enable the detection of risk of Obstructive sleep apnea among Oral submucous fibrosis patients  first day at the time of diagnosing 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="23" 
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)   21/02/2025 
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="1"
Months="0"
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 - NO
Brief Summary  

The reduction in airway will be analyzed with this study, adds another dimension of concern related to the impact caused by OSMF, other than oral cavity. So, with the help of parameters used in this study, risk of Obstructive sleep apnea in OSMF patients will be evaluated, thereby, decreasing the mortality rate.

This highlights the need to evaluate the upper airway dimension in Oral submucous fibrosis patients using Cone beam computed tomography

Evaluation of volume of airway using CBCT

·         The CBCT findings that will be analyzed includes the total length of the upper airway, the total airway volume of the oropharyngeal region, the average airway volume of the oropharyngeal region, and the smallest width and anteroposterior (AP) measurements.

·         The oropharynx region will be isolated and analyzed using manual segmentation of each axial slice

·         Using sagittal sections, the total length of the upper airway will be gathered by measuring the length between the lowest border of the C2 vertebra and the posterior nasal spine (PNS).

·         Total airway volume will be obtained through a 3-dimensional volumetric analysis of the upper respiratory tract obtained by tracing a curved line joining dots placed in the middle of the airway at each axial slice.

·         The average airway volume will be automatically generated by the software by dividing the total airway volume by the number of axial slice segmentations.

·         The narrowest area of the airway will be determined by dragging a cursor along the curved line to check the average area at each section.

·         The corresponding location will be viewed in an axial slice to obtain the upper airway’s smallest width and AP measurements.

Evaluation of soft palate using CBCT

·         The critical ratio between soft palate length (VL) and nasopharyngeal depth (PD), known as Need’s ratio (NR), is used to ascertain velopharyngeal incompetency (VPI).[13]

·         The VL will be measured as a linear distance from the posterior nasal spine (PNS) to the tip of the uvula of the resting soft palate.

·         The thickest section of velum is known as velar width (VW).

·         The PD was taken as a linear measurement from the PNS to the posterior pharyngeal wall along the palatal plane. The NR will be calculated for all the subjects by dividing the PD with VL

 

 
 
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