PeriodontitisHerPerioNCT05631288
Association of Herpesvirus and Periodontitis
An observational study of Periodontitis, run by Miguel de Araújo Nobre at 1 site in Portugal.
Trial summary
A significant influence of the Herpes viruses family in the progression of periodontal disease has been suggested. The aim of this study was to investigate the potential association of four Herpes viruses (HSV-1, HSV-2, CMV and EBV) with periodontal disease using a qualitative test for evaluating the presence or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Sampe collection
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2019to 1 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients (> 18 years of age) with natural teeth present attending clinical appointments at the Egas Moniz university dental clinic.
Who may be able to join
- Patients (> 18 years of age) with natural teeth attending clinical appointments at the Egas Moniz university dental clinic;
- Cases (periodontally compromised) included at the Department of Periodontology of the same clinic;
- Controls (periodontally healthy) included at the remaining departments of the same clinic.
Who cannot join
- Occurrence of a viral infection during the six months prior to the clinical study;
- Exposure to antiviral medication in the six months prior to the survey;
- Clinical history of immunosuppression, either exogenous or endogenous;
- Chemotherapy in the previous six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Herpesvirus and Periodontitis: A Clinical and Laboratorial Case-control Study
A significant influence of the Herpes viruses family in the progression of periodontal disease has been suggested. The aim of this study was to investigate the potential association of four Herpes viruses (HSV-1, HSV-2, CMV and EBV) with periodontal disease using a qualitative test for evaluating the presence or absence of viral DNA in crevicular fluid samples of both healthy periodontal patients and periodontal compromised patients.
Adult patients with healthy periodontium or periodontally compromised attending the Egas Moniz university dental clinic (Almada, Portugal) are eligible to participate The study involves a periodontal diagnosis and collection of unstimulated crevicular fluid from saliva samples.
Read more
There will be no direct benefits for patients, but indirect benefit of advancing science in the study of potential involvment of Herpes viruses in periodontitis. No risks of participating are antecipated as the study material and data will be anonymized.
The study runs from the the Cooperativa de Ensino Egas Moniz and is expected to run for 3 months.
- Conditions
- Periodontitis
- Being tested
- Sampe collection
- Keywords
- periodontitis, herpes virus
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampe collectionGenetic
Unstimulated crevicular fluid samples are collected using two sized 35 paper cones per subject, both used in the sampling process. The DNA is extracted from the samples through multiplex PCR at the Egas Moniz Applied Microbiology Laboratory (LMAEM).
| Study group | Role | What they receive |
|---|---|---|
| Cases | Periodontally compromised patients attending the Periodontology Department during periodontal diagnosis appointments at the point of first diagnosis. Receives: Genetic: Sampe collection | |
| Controls | Periodontally healthy patients attending the remaining specialty departments ath the same clinic at the point of first diagnosis. Receives: Genetic: Sampe collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of virus DNA (HSV1, HSV2, EBV and CMV)
The presence of virus DNA (HSV1, HSV2, EBV and CMV)
Measured: 1 day
Secondary outcomes (3)
Smoking
[Smoking] (smoker, non-smoker) measured through questionnaire at first appointment;
Measured: one year
Alcohol consumption
[Alcohol consumption] (yes, no) measured through questionnaire at first appointment;
Measured: one year
Oral hygiene habits
[Oral hygiene habits] (0-1 times per day, 1-2 times per day and 2-3 times per day) measured through questionnaire at first time appointment.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Mar 2019
- Primary completion31 Jul 2019
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miguel de Araújo Nobre
- Sponsor type
- University, hospital or other
- Collaborators
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Responsible party
- Sponsor-investigator, Miguel de Araújo Nobre, Malo Clinic
- Investigators
- Miguel A de Araújo Nobre, PhD, Study director, Maló Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631288
- Sponsor's protocol ID
- HerPerio
- Acronym
- HerPerio
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: he datasets generated during and/or analysed during the current study will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Herpesvirus and Periodontitis: A Clinical and Laboratorial Case-control Study
- ClinicalTrials.gov ID
- NCT05631288
- Acronym / sponsor ID
- HerPerio / HerPerio
- Conditions
- Periodontitis
- Keywords
- periodontitis, herpes virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Miguel de Araújo NobreUniversity, hospital or other
- Collaborators
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 30 Nov 2022 (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.
A significant influence of the Herpes viruses family in the progression of periodontal disease has been suggested. The aim of this study was to investigate the potential association of four Herpes viruses (HSV-1, HSV-2, CMV and EBV) with periodontal disease using a qualitative test for evaluating the presence or absence of viral DNA in crevicular fluid samples of both healthy periodontal patients and periodontal compromised patients.
Adult patients with healthy periodontium or periodontally compromised attending the Egas Moniz university dental clinic (Almada, Portugal) are eligible to participate The study involves a periodontal diagnosis and collection of unstimulated crevicular fluid from saliva samples.
There will be no direct benefits for patients, but indirect benefit of advancing science in the study of potential involvment of Herpes viruses in periodontitis. No risks of participating are antecipated as the study material and data will be anonymized.
The study runs from the the Cooperativa de Ensino Egas Moniz and is expected to run for 3 months.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Genetic: Sampe collectionPeriodontally compromised patients attending the Periodontology Department during periodontal diagnosis appointments at the point of first diagnosis. |
| Controls | – | Genetic: Sampe collectionPeriodontally healthy patients attending the remaining specialty departments ath the same clinic at the point of first diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (> 18 years of age) with natural teeth present attending clinical appointments at the Egas Moniz university dental clinic.
Key inclusion criteria (3 listed)
- Patients (> 18 years of age) with natural teeth attending clinical appointments at the Egas Moniz university dental clinic;
- Cases (periodontally compromised) included at the Department of Periodontology of the same clinic;
- Controls (periodontally healthy) included at the remaining departments of the same clinic.
Key exclusion criteria (4 listed)
- Occurrence of a viral infection during the six months prior to the clinical study;
- Exposure to antiviral medication in the six months prior to the survey;
- Clinical history of immunosuppression, either exogenous or endogenous;
- Chemotherapy in the previous six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampe collectionUnstimulated crevicular fluid samples are collected using two sized 35 paper cones per subject, both used in the sampling process. The DNA is extracted from the samples through multiplex PCR at the Egas Moniz Applied Microbiology Laboratory (LMAEM). | Genetic | Cases, Controls |
Primary outcome
The presence of virus DNA (HSV1, HSV2, EBV and CMV)
Time frame: 1 day
The presence of virus DNA (HSV1, HSV2, EBV and CMV)
3 secondary outcomes
Smoking
Time frame: one year
Alcohol consumption
Time frame: one year
Oral hygiene habits
Time frame: one year
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 30 Nov 2022.
- Individual participant dataSharing planned: Yes. he datasets generated during and/or analysed during the current study will be available upon reasonable request.
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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.
Miguel A de Araújo Nobre, PhD study director
Maló Clinic
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 Periodontitis, run by Miguel de Araújo Nobre at 1 site in Portugal.
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 3 inclusion and 4 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 30 Nov 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 Portugal. 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?
The presence of virus DNA (HSV1, HSV2, EBV and CMV) (time frame: 1 day). 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 30 Nov 2022.