NCT03928730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
Last Updated

November 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

April 21, 2019

Last Update Submit

November 1, 2021

Conditions

Swelling Lips & Face

Outcome Measures

Primary Outcomes (1)

  • Correlation between ultrasonographic features and swellings types

    Correlation between ultrasonographic features and swellings types

    2 months

Study Arms (5)

Group I

OTHER

Inflammatory swellings

Procedure: resection and removal

Group II

OTHER

Cystic swellings

Procedure: resection and removal

Group III

OTHER

Lymph node swellings

Procedure: resection and removal

Group IV

OTHER

Benign swellings

Procedure: resection and removal

Group V

OTHER

Malignant swellings

Procedure: resection and removal

Interventions

resection and removalPROCEDURE

Surgical resection or removal for histopathological examination

Group IGroup IIGroup IIIGroup IVGroup V

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All with oral and/or maxillofacial swelling,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MiniaU

Minya, 51611, Egypt

Location

MeSH Terms

Conditions

Facies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

April 21, 2019

First Posted

April 26, 2019

Study Start

January 1, 2020

Primary Completion

February 3, 2021

Study Completion

February 20, 2021

Last Updated

November 2, 2021

Record last verified: 2021-11

Locations

EG(1)