Evaluation of Oral and Maxillofacial Swellings by Ultrasonographic Features

Swelling Lips & Face Clinical Trial

— Research  

Official title:

Assessment of Ultrasonographic Examination for Maxillofacial Swellings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928730
• Other study ID #: TAbdallah
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 20, 2021

Study information

• Verified date: November 2021
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 20, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Swelling Lips & Face

Intervention

Procedure:
• resection and removal
Surgical resection or removal for histopathological examination

Locations

Country	Name	City	State
Egypt	MiniaU	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Tarek A Abdelsalam, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between ultrasonographic features and swellings types	Correlation between ultrasonographic features and swellings types	2 months