Evaluation of Oral and Maxillofacial Swellings by Ultrasonographic Features

Not Applicable

Completed

• Conditions: Swelling Lips & Face
• Interventions: Procedure: resection and removal

• Registration Number: NCT03928730
• Lead Sponsor: Tarek A Abdelsalam, MD

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2019-04-21
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Study Start: 2020-01-01
• Primary Completion: 2021-02-03
• Study Completion: 2021-02-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group II	resection and removal	Cystic swellings
Group III	resection and removal	Lymph node swellings
Group I	resection and removal	Inflammatory swellings
Group V	resection and removal	Malignant swellings
Group IV	resection and removal	Benign swellings

Primary Outcome Measures

Name	Time	Method
Correlation between ultrasonographic features and swellings types	2 months	Correlation between ultrasonographic features and swellings types

Trial Locations

Locations (1)

MiniaU; 🇪🇬 Minya, Egypt