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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03717389
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Cairo University
Information provided by (Responsible Party):
Maha Samy Elhadidy, Cairo University

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.

Condition or disease Intervention/treatment
Oral Soft Tissue Conditions Other: presence of soft tissue calcification in head and neck

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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Prevalence of Soft Tissue Calcifications in the Head and Neck Region Using CBCT Among Egyptian Population: Observational Cross Sectional Study
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Intervention Details:
  • Other: presence of soft tissue calcification in head and neck
    soft tissue calcifications of the head and neck region in the Egyptian population

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes 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

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.

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Responsible Party: Maha Samy Elhadidy, postgraduate student, Cairo University Identifier: NCT03717389    
Other Study ID Numbers: 2371987
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maha Samy Elhadidy, Cairo University:
soft tissue calcification in head and neck
Additional relevant MeSH terms:
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Calcium Metabolism Disorders
Metabolic Diseases