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Evaluation of Oral and Maxillofacial Swellings by Ultrasonographic Features

  • Clinicaltrials.gov identifier

    NCT03928730

  • Recruitment Status

    Terminated (we are finished)

  • First Posted

    April 26, 2019

  • Last update posted

    February 26, 2021

Study Description

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:Swelling Lips & Face
  • Intervention/Treatment: Procedure: resection and removal
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Actual 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
  • Actual Study Start Date: January 2020
  • Actual Primary Completion Date: February 2021
  • Actual Study Completion Date: February 2021

Arms and interventions

Arm Intervention/treatment
Other: Group I
Inflammatory swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination
Other: Group II
Cystic swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination
Other: Group III
Lymph node swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination
Other: Group IV
Benign swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination
Other: Group V
Malignant swellings
Procedure: resection and removal
Surgical resection or removal for histopathological examination

Outcome Measures

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

Eligibility Criteria

  • 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.

Contacts and Locations

Contacts

Locations

Egypt
MiniaU
Minya

Sponsors and Collaborators

Tarek A Abdelsalam, MD

More Information

  • Responsible Party: Tarek A Abdelsalam, MD
  • ClinicalTrials.gov Identifier: NCT03928730 History of Changes
  • Other Study ID Numbers: TAbdallah
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: February 26, 2021
  • Last Verified: February 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes