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Evaluation of Oral and Maxillofacial Swellings by Ultrasonographic Features (Research)

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ClinicalTrials.gov Identifier: NCT03928730
Recruitment Status : Not yet recruiting
First Posted : April 26, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Tarek Abdallah, Minia University

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.

Condition or disease Intervention/treatment Phase
Swelling Lips & Face Procedure: resection and removal Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Ultrasonographic Examination for Maxillofacial Swellings
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Arm Intervention/treatment
Group I
Inflammatory swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination

Group II
Cystic swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination

Group III
Lymph node swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination

Group IV
Benign swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination

Group V
Malignant swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination




Primary Outcome Measures :
  1. Correlation between ultrasonographic features and swellings types [ Time Frame: 2 months ]
    Correlation between ultrasonographic features and swellings types



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Tarek Abdallah, Dentist, Minia University
ClinicalTrials.gov Identifier: NCT03928730     History of Changes
Other Study ID Numbers: TAbdallah
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No