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临床试验/CTRI/2025/02/080816
CTRI/2025/02/080816尚未招募不适用

Evaluation of upper airway dimensions using cone-beam computed tomography in Oral submucous fibrosis patients-A cross-sectional study

Dr Pavithra G1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2025年2月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
23
试验地点
1
主要终点
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

研究概览

简要总结

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

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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
  • Improper CBCT imaging displaying a posterior positioning of the tongue which may affect measurements will be excluded from the study.

结局指标

主要结局

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

时间窗: first day at the time of diagnosing

次要结局

未报告次要终点

研究者

发起方
Dr Pavithra G
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Pavithra G

KLE Vishwanath Katti Institute of Dental Sciences

研究点 (1)

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