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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812990
• Other study ID #: HC IN EGYPT
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2023
• Source: Misr University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2021
• Est. primary completion date: July 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• in Egyptian Population
• Oral Manifestations

Locations

Country	Name	City	State
Egypt	Faculty of dentistry at MUST	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral lesion relation to hepatitis c	the prevalence to oral lesions related to hepatitis C patients	six months