NCT04092699

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

September 11, 2019

Last Update Submit

September 13, 2019

Conditions

Keywords

CBCTmaxillary sinussegmentation

Outcome Measures

Primary Outcomes (1)

  • Validity and reliability of CBCT semiautomatic segmentation in Volumetric measurements of maxillary sinus.

    validity and reliability

    1 year

Study Arms (2)

patient

OTHER

CBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software

Device: semiautomatic software

skulls

OTHER

CBCT Dicom file of patient has been scanned will be used for measurements of maxillary sinus volume by different software

Device: semiautomatic software

Interventions

semiautomatic segmentation is as accurate as the direct volume of maxillary sinus and as well as the manual segmentation.

Also known as: Mimics medical 19., Romexis, On Demand 3D
patientskulls

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Patients without any pathosis affects maxillary sinus.
  • Patients with dentulous or edentulous jaws.
  • Patients with traumatic injuries, diseases and space occupying lesions of maxilla.
  • Patients with sinus lifting or surgeries.
  • Patients with mucosal thickening more than 3mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Reham Ashraf, master

    Reham Ashraf Hussien

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reham Ashraf, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 17, 2019

Study Start

October 1, 2019

Primary Completion

June 1, 2020

Study Completion

September 1, 2020

Last Updated

September 17, 2019

Record last verified: 2019-09