Clinical trial NCT04092699: CBCT Segmentation in Volumetric Measurements of MS Using Different Soft Wares: A Validity and Reliability Study
Official title: Cone Beam Computed Tomographic Segmentation in Volumetric Measurements of Maxillary Sinus Using Different Soft Wares: A Validity and Reliability Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Volume
CBCT Segmentation
Keywords: CBCT
maxillary sinus
segmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Cone Beam Computed Tomography (CBCT) has been used to assess the volume of the maxillary sinus using the manual and semi-automatic segmentation. The majority of researches stressed on the reduced accuracy of the automatic segmentation when compared to the real volume. Regarding the semi-automatic segmentation, there are researches assessed the volumetric measurement of the maxillary sinus and they reported that there is no significant difference between semi- automatic and the manual segmentation in CT.

Detailed description: Automatic segmentation is believed to be less time consuming and more accurate in assessment of structures with regular border but fairly assessed the structures with irregular border like paranasal sinuses. The semi-automatic software is efficient and accurate as manual tracing with significant reduction in inter-observer variability and time . On the other hand, all neighboring contacting voxels located within a defined range (threshold) of similar HU values of different adjacent tissues may be measured so over calculation or under calculation could be suspected

Eligibility criteria: Inclusion Criteria:

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Inclusion Criteria of participants of the In vitro part of the study:

* Skulls with intact walls of maxillary sinus.
* Skulls with dentulous or edentulous jaws.

Exclusion criteria of participants:

* Skulls with missing parts of the maxilla that could be caused from traumatic injuries, diseases and space occupying lesions of maxilla.
* Skulls with severe mutilation caused by environmental decay.

Inclusion Criteria of participants of the In vivo part of the study:

* Patients without any pathosis affects maxillary sinus.
* Patients with dentulous or edentulous jaws.

Exclusion criteria of participants:

* Patients with traumatic injuries, diseases and space occupying lesions of maxilla.
* Patients with sinus lifting or surgeries.
* Patients with mucosal thickening more than 3mm

Primary outcomes:
measure: Validity and reliability of CBCT semiautomatic segmentation in Volumetric measurements of maxillary sinus.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Reham Ashraf Hussien
name: Reham Ashraf, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berberi A, Bouserhal L, Nader N, Assaf RB, Nassif NB, Bouserhal J, Salameh Z. Evaluation of Three-Dimensional Volumetric Changes After Sinus Floor Augmentation with Mineralized Cortical Bone Allograft. J Maxillofac Oral Surg. 2015 Sep;14(3):624-9. doi: 10.1007/s12663-014-0736-3. Epub 2014 Dec 24.
citation: Alsufyani NA, Flores-Mir C, Major PW. Three-dimensional segmentation of the upper airway using cone beam CT: a systematic review. Dentomaxillofac Radiol. 2012 May;41(4):276-84. doi: 10.1259/dmfr/79433138.
citation: El H, Palomo JM. Measuring the airway in 3 dimensions: a reliability and accuracy study. Am J Orthod Dentofacial Orthop. 2010 Apr;137(4 Suppl):S50.e1-9; discussion S50-2. doi: 10.1016/j.ajodo.2010.01.014.