The Prevalence of Soft Tissue Calcifications in the Head and Neck Region Using CBCT Among Egyptian Population

October 22, 2018 updated by: Maha Samy Elhadidy

The Prevalence of Soft Tissue Calcifications in the Head and Neck Region Using CBCT Among Egyptian Population: Observational Cross Sectional Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Calcification of various structures located in the head and neck region are reported in patients seeking dental care.

Although most of the soft tissue calcification within the head and neck region might not be accompanied by clinical symptoms; the investigators should not assume that their detection do not has a strong clinical significance .

Some soft tissue calcification may suggest the presence of a systemic condition and may cause threatening consequences .

Understanding of the nature of soft tissue calcification in the head and neck helps in proper diagnosis of these calcification and in turn taking the right decision of asking for further investigation; referral or do nothing .

Also; many of the structures in the head and neck region are in close proximity to one another which makes identification and localization difficult and this may lead to false diagnosis .

CBCT is a valuable imaging modality to overcome this difficulty. The data collection for this study will be obtained from the data base available at the Oral and Maxillofacial Radiology department at the faculty of dentistry -Cairo university

The following information will be recorded for each patient by :

1. Age of the patient at the time of the scan . 2. Sex (male or female). 3. Type of the scan (mandible only, maxilla and mandible, and full scan).

  • Assessment will be made for the following;

    1. Presence or absence of calcification.
    2. Type of calcification present (or what is this soft tissue structure).
    3. Side (i.e. unilateral or bilateral and what side) .
    4. Single or multiple occurring.
  • During assessing the CBCT images; neither clinical information nor demographic data of the patients will be available to any of the two radiologists.
  • Then inter-observational and intra-observational variability between the observers will be evaluated.

Study Type

Observational

Enrollment (Anticipated)

350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
what is percent of participants having soft tissue calcification among the whole population included"whether males or females"
Time Frame: the participants will be assessed 2 times at 2 weeks interval
percentage%
the participants will be assessed 2 times at 2 weeks interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maha Samy Elhadidy

Collaborators

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2371987

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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