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Evaluation of Oral and Maxillofacial Swellings by Ultrasonographic Features

NCT ID: NCT03928730

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-02-20

Brief Summary

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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

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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

Conditions

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Swelling Lips & Face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group I

Inflammatory swellings

Group Type OTHER

resection and removal

Intervention Type PROCEDURE

Surgical resection or removal for histopathological examination

Group II

Cystic swellings

Group Type OTHER

resection and removal

Intervention Type PROCEDURE

Surgical resection or removal for histopathological examination

Group III

Lymph node swellings

Group Type OTHER

resection and removal

Intervention Type PROCEDURE

Surgical resection or removal for histopathological examination

Group IV

Benign swellings

Group Type OTHER

resection and removal

Intervention Type PROCEDURE

Surgical resection or removal for histopathological examination

Group V

Malignant swellings

Group Type OTHER

resection and removal

Intervention Type PROCEDURE

Surgical resection or removal for histopathological examination

Interventions

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resection and removal

Surgical resection or removal for histopathological examination

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tarek A Abdelsalam, MD

OTHER

Sponsor Role lead

Responsible Party

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Tarek A Abdelsalam, MD

Dentist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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MiniaU

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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TAbdallah

Identifier Type: -

Identifier Source: org_study_id