Hepatitis CNCT04812990
A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt
An observational study of Hepatitis C and Oral Manifestations, run by Misr University for Science and Technology at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Oral Manifestations, in Egyptian Population
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hepatic (virus C) and non hepatic patients on Egyptian population
Who may be able to join
- patients previously diagnosed with hepatits c, with education, ability and willing to participate in the study
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Hepatitis C, Oral Manifestations, in Egyptian Population
- Medical subject headings
- Hepatitis C, Oral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral lesion relation to hepatitis c
the prevalence to oral lesions related to hepatitis C patients
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Mar 2021
- Primary completion4 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Elsherif, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812990
- Sponsor's protocol ID
- HC IN EGYPT
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2021
- Last updated
- 20 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt
- ClinicalTrials.gov ID
- NCT04812990
- Acronym / sponsor ID
- HC IN EGYPT
- Conditions
- Hepatitis C, Oral Manifestations, in Egyptian Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 4 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hepatic (virus C) and non hepatic patients on Egyptian population
Key inclusion criteria (1 listed)
- patients previously diagnosed with hepatits c, with education, ability and willing to participate in the study
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oral lesion relation to hepatitis c
Time frame: six months
the prevalence to oral lesions related to hepatitis C patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Oral Manifestations, run by Misr University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral lesion relation to hepatitis c (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.