NCT04812990

Brief Summary

Hepatitis C virus (HCV) is the major cause of chronic liver disease and has a long-term resultant complications4 and it considered as a major endemic medical health problem in Egypt. It affects multiple organs and reflect various manifestations on oral cavity.The purpose of this study is to assess the prevalence of oral mucosa conditions, type of oral manifestation and gingival lesions in patients with hepatitis C

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 20, 2021

Last Update Submit

March 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • oral lesion relation to hepatitis c

    the prevalence to oral lesions related to hepatitis C patients

    six months

Study Arms (2)

hepatitis c patients

50 patients will be recruited for study group from consecutive patients previously diagnosed by hepatitis C regardless of the etiology of the condition and regularly attending at Soad Kafay hospital. Participants with history of smoking and alcoholism that could affect their oral health status were excluded.

clinically healthy patients

populations will be randomly recruited from the out-patient of dental diagnosis clinic in Misr University For science \& technology university to include total 50 clinically healthy participants, with no history of liver disease, or any other chronic debilitating illness, or habit of smoking or drinking, , as well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy and/or not receiving any medication that could affect oral health.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hepatic (virus C) and non hepatic patients on Egyptian population

You may qualify if:

  • patients previously diagnosed with hepatits c, with education, ability and willing to participate in the study

You may not qualify if:

  • Patients with systemic diseases such as nutritional deficiency; cardiovascular, respiratory, metabolic, and endocrinal disorders; also smoking and alcoholism that could affect their oral health status were excluded. As well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry at MUST

Giza, 02, Egypt

Location

MeSH Terms

Conditions

Hepatitis COral Manifestations

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesMouth DiseasesStomatognathic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 24, 2021

Study Start

March 1, 2021

Primary Completion

July 4, 2021

Study Completion

August 1, 2021

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations