HIV InfectionsDENTA-VIHNCT05123547
DENTAL CARE OF PATIENTS LIVING WITH HIV
An observational study of HIV Infections, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2021to 21 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people living with HIV
Who may be able to join
- Adult patient infected with HIV or co-infected with HIV / HBV or HIV / HCV followed in the Infectious Diseases department of Clermont-Ferrand University Hospital and affiliated to a social security scheme.
Who cannot join
- Minor patient
- Adult patient unable to express his non-opposition to participating in the study or patient who refuses to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DENTAL CARE OF PATIENTS LIVING WITH HIV, OR COINFECTED HIV / HBV OR HIV / HCV, FOLLOWED IN THE INFECTIOUS DISEASES DEPARTMENT OF CHU CLERMONT-FERRAND
This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.
Read the detailed description
In the purpose of identifying oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV, we would recruit from 15 10 2021 to 15 04 2022 affiliated to social security scheme PLWHIV adults followed-up in the infectious diseases department of Clermont-Ferrand university hospital who accept participate in order to propose dental individual clinical exams. Anonymous socio-demograpic, medical and dental data will be reported in Redcap. Primary outcomes are the number and type of pathologies identified linked to HIV or not. Statistical analysed will be performed with Stata software. The population will be described by associated numbers and percentages for the categorical variables and by the mean ± standard deviation or median [interquartile interval] for the quantitative variables, with respect to their statistical distribution.
- Conditions
- HIV Infections
- Keywords
- HIV, Dental care
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
description of oral disease linked to HIV or not.
percentage of patients with oral disease linked to HIV and percentage of patients with oral disease not linked to HIV
Measured: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Secondary outcomes (4)
Study the factors associated with the presence of oral pathologies linked to HIV.
bivariate and multivariate analysis of demographic, immunovirologic factors and comorbidities associated to oral diseases linked to HIV
Measured: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Study the factors associated with the presence of oral pathologies unrelated to HIV.
bivariate and multivariate analysis of demographic, immunovirologic factors and comorbidities associated with the presence of oral pathologies unrelated to HIV
Measured: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Compare the prevalence of oral pathologies linked or not to HIV with that found in a previous study carried out in 2003.
comparison of prevalence of oral diseases in 2021 and those in 2003 in CHU Clermont Ferrand
Measured: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
List the course of dental care of these people during the last 3 years.
% refusal care, % lost of dental follow-up
Measured: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start21 Oct 2021
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine JACOMET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123547
- Sponsor's protocol ID
- RNI 2021 JACOMET 3
- Other IDs
- 2021-A01831-40
- Acronym
- DENTA-VIH
- Status last verified
- May 2022
- First submitted
- 18 Oct 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DENTAL CARE OF PATIENTS LIVING WITH HIV, OR COINFECTED HIV / HBV OR HIV / HCV, FOLLOWED IN THE INFECTIOUS DISEASES DEPARTMENT OF CHU CLERMONT-FERRAND
- ClinicalTrials.gov ID
- NCT05123547
- Acronym / sponsor ID
- DENTA-VIH / RNI 2021 JACOMET 3
- Conditions
- HIV Infections
- Keywords
- HIV, Dental care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 17 Nov 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.
This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.
Detailed description
In the purpose of identifying oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV, we would recruit from 15 10 2021 to 15 04 2022 affiliated to social security scheme PLWHIV adults followed-up in the infectious diseases department of Clermont-Ferrand university hospital who accept participate in order to propose dental individual clinical exams. Anonymous socio-demograpic, medical and dental data will be reported in Redcap. Primary outcomes are the number and type of pathologies identified linked to HIV or not. Statistical analysed will be performed with Stata software. The population will be described by associated numbers and percentages for the categorical variables and by the mean ± standard deviation or median [interquartile interval] for the quantitative variables, with respect to their statistical distribution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people living with HIV
Key inclusion criteria (1 listed)
- Adult patient infected with HIV or co-infected with HIV / HBV or HIV / HCV followed in the Infectious Diseases department of Clermont-Ferrand University Hospital and affiliated to a social security scheme.
Key exclusion criteria (2 listed)
- Minor patient
- Adult patient unable to express his non-opposition to participating in the study or patient who refuses to participate in the study.
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
description of oral disease linked to HIV or not.
Time frame: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
percentage of patients with oral disease linked to HIV and percentage of patients with oral disease not linked to HIV
4 secondary outcomes
Study the factors associated with the presence of oral pathologies linked to HIV.
Time frame: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Study the factors associated with the presence of oral pathologies unrelated to HIV.
Time frame: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
Compare the prevalence of oral pathologies linked or not to HIV with that found in a previous study carried out in 2003.
Time frame: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
List the course of dental care of these people during the last 3 years.
Time frame: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand
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 19 May 2022.
- Individual participant dataSharing planned: No
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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.
Christine JACOMET principal investigator
University Hospital, Clermont-Ferrand
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 HIV Infections, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 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 19 May 2022. 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 France. 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?
description of oral disease linked to HIV or not. (time frame: During the scheduled consultation in the infectious diseases department of the Gabriel Montpied University Hospital in Clermont-Ferrand). 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 19 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.