NCT03717389

Brief Summary

Prevalence of soft tissue calcifications in the head and neck region is not clearly studied in the Egyptian population. Determining the incidence of these calcifications can improve the knowledge of dental practitioners and allow such practitioners to initiate proper diagnostic. And if patients need treatment they can start early by the right therapy to stop the. The aim of this research is to detect and quantify the prevalence of the soft tissue calcifications by cone beam computed tomography (CBCT) images of the head and neck region in the Egyptian population.

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
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

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

October 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 18, 2018

Last Update Submit

October 22, 2018

Conditions

Keywords

prevalencesoft tissue calcification in head and neck

Outcome Measures

Primary Outcomes (1)

  • what is percent of participants having soft tissue calcification among the whole population included"whether males or females"

    percentage%

    the participants will be assessed 2 times at 2 weeks interval

Interventions

soft tissue calcifications of the head and neck region in the Egyptian population

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 350 CBCT scans belonging to Egyptian individuals who had CBCT examination as part of their dental treatment planning during the years 2017-2018-2019.from the data base available at the Oral and Maxillofacial Radiology department at the faculty of dentistry -Cairo university

You may qualify if:

  • CBCT scans of 0.2 mm Voxel size will be included
  • Scans that clearly show mandible only; maxilla only; maxilla and mandible or whole face will be included.
  • Patients age 10-80 years old .

You may not qualify if:

  • Images with (Field Of View) show only one tooth or teeth.
  • Images of poor quality will be excluded.
  • Images showing artifacts caused by metallic implants or osteosynthesis plates.
  • Images subjected to patient movement during acquisition will be excluded also.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Khojastepour L, Haghnegahdar A, Sayar H. Prevalence of Soft Tissue Calcifications in CBCT Images of Mandibular Region. J Dent (Shiraz). 2017 Jun;18(2):88-94.

    PMID: 28620632BACKGROUND
  • Caglayan F, Sumbullu MA, Miloglu O, Akgul HM. Are all soft tissue calcifications detected by cone-beam computed tomography in the submandibular region sialoliths? J Oral Maxillofac Surg. 2014 Aug;72(8):1531.e1-6. doi: 10.1016/j.joms.2014.04.005. Epub 2014 Apr 13.

    PMID: 25037186BACKGROUND
  • Guarda-Nardini L, Piccotti F, Ferronato G, Manfredini D. Myositis ossificans traumatica of the temporalis muscle: a case report and diagnostic considerations. Oral Maxillofac Surg. 2012 Jun;16(2):221-5. doi: 10.1007/s10006-011-0293-6. Epub 2011 Sep 22.

    PMID: 21938392BACKGROUND
  • Lewis DA, Brooks SL. Cartoid artery calcification in a general dental population: a retrospective study of panoramic radiographs. Gen Dent. 1999 Jan-Feb;47(1):98-103.

    PMID: 10321159BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
postgraduate student

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 24, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

June 1, 2020

Last Updated

October 24, 2018

Record last verified: 2018-10