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.|
|ClinicalTrials.gov Identifier: NCT03717389|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
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|
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;
- Presence or absence of calcification.
- Type of calcification present (or what is this soft tissue structure).
- Side (i.e. unilateral or bilateral and what side) .
- 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|
|Estimated Enrollment :||350 participants|
|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|
- Other: presence of soft tissue calcification in head and neck
soft tissue calcifications of the head and neck region in the Egyptian population
- 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%