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OpenTrials
Completed

NCT Number: NCT03928730

Evaluation of Oral and Maxillofacial Swellings by Ultrasonographic Features

Fifty patients were randomly selected with oral and/or maxillofacial swelling, thorough case history and clinical examination were done, then ultrasound examinations were done for all of them and they were classified into five groups (I. inflammatory/space infection and abscess swellings), (II. cystic swellings), (III. lymph node swellings), (IV. benign swellings) and (V. malignant neoplastic swellings) according to their ultrasound features. The patients were subjected to histopathologic evaluation.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MiniaU

Minya, 51611, Egypt

About this study

Fifty patients with swellings in the oral and/or maxillofacial region were randomly selected. Any other swellings that were caused by trauma and/or fracture, extended below the neck or patient reluctant to undergo US were excluded from the study. This study was approved by the (Research Ethics Committee) (REC), Faculty of Dentistry, Minia University before starting the research and all the entire patients had signed a standardized informed consent laid down by REC.

A comprehensive questionnaire was used to assess history and through extra-oral & intra-oral examinations were carried out and recorded on the basis of criteria reported by Das.11 The ultrasonographic investigations were carried using an ultrasound diagnostic modality (LOGIQ- P5) (GE Medical System, Korea) with color Doppler function by using a linear array transducer, operating at a frequency of (7.5-12 MHz). All the examinations were performed over the swellings and also compared to the contra-lateral/normal side whenever needed. (Fig. 1) All sonographic images were interpreted by an expert sonologist (15 years experience) and US features were recorded to extract ultrasonographic guided (USG) diagnosis and patient's swellings were categorized into five groups: inflammatory/infection/abscess swellings (Group I), cystic swellings (Group II), lymph node swellings (Group III), benign swellings (Group IV) and malignant neoplastic swellings (Group V).12 Finally, the included patients were subjected to either fine needle aspiration cytology (FNAC) or surgical intervention for histopathological examination to extract the histopathological diagnosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All with oral and/or maxillofacial swelling,

Exclusion criteria

  • Any other swellings that were caused by trauma and/or fracture, extended below the neck or patient reluctant to undergo US were excluded from the study.

Treatment and study plan

resection and removal

Procedure

Surgical resection or removal for histopathological examination

Primary outcomes

  1. Correlation between ultrasonographic features and swellings types

    Time frame: 2 months

    Correlation between ultrasonographic features and swellings types

Sponsors and collaborators

Lead sponsor

Tarek A Abdelsalam, MD

Other

Registry information

Official study title

Assessment of Ultrasonographic Examination for Maxillofacial Swellings

Acronym: Research

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2019
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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