A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt

Sponsor
Misr University for Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT04812990
Collaborator
(none)
100
2
5
50
9.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study design: It is a cross sectional observational study. Sample size estimation: 100 patients (50 in each groups) A total of 100 adult participants of both genders above 18 years will be included in the study, patients was able and willing to participate in the study. 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. The control group 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.

    Changes in the oral cavity was recorded on the entire mucosal surface recording signs, symptoms, and oral lesion absence or presence. All the information will be recorded and the data will be analyzed after the end of the study . The prevalence of various oral manifestations in hepatitis C patients will be documented.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt
    Actual Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2021
    Anticipated Study Completion Date :
    Aug 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. oral lesion relation to hepatitis c [six months]

      the prevalence to oral lesions related to hepatitis C patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients previously diagnosed with hepatits c, with education, ability and willing to participate in the study
    Exclusion Criteria:
    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of dentistry at MUST Giza Egypt 02
    2 faculty of dentistry at MUST Giza Egypt 02

    Sponsors and Collaborators

    • Misr University for Science and Technology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radwa Elsherif, LECTURER, Misr University for Science and Technology
    ClinicalTrials.gov Identifier:
    NCT04812990
    Other Study ID Numbers:
    • HC IN EGYPT
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Mar 24, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2021