| 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
|
|
|
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
|
|
|
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
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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 tomographyEvaluation 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 |