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Completed

NCT Number: NCT05631288

Association of Herpesvirus and Periodontitis

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Malo Clinic

Lisbon, 1600-042, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sampe collection

Genetic

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).

Primary outcomes

  1. The presence of virus DNA (HSV1, HSV2, EBV and CMV)

    Time frame: 1 day

    The presence of virus DNA (HSV1, HSV2, EBV and CMV)

Secondary outcomes

  1. Smoking

    Time frame: one year

    [Smoking] (smoker, non-smoker) measured through questionnaire at first appointment;

  2. Alcohol consumption

    Time frame: one year

    [Alcohol consumption] (yes, no) measured through questionnaire at first appointment;

  3. Oral hygiene habits

    Time frame: one year

    [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.

Sponsors and collaborators

Lead sponsor

Miguel de Araújo Nobre

Other

Collaborators

  • Egas Moniz - Cooperativa de Ensino Superior, CRL

Registry information

Official study title

Association of Herpesvirus and Periodontitis: A Clinical and Laboratorial Case-control Study

Acronym: HerPerio

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Nov 30, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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