Association of Herpesvirus and Periodontitis (HerPerio)

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.

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 Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Genetic: Sampe collection

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal, 1600-042
    • Malo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients (> 18 years of age) with natural teeth present attending clinical appointments at the Egas Moniz university dental clinic.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Periodontally compromised patients attending the Periodontology Department during periodontal diagnosis appointments at the point of first diagnosis.	Genetic: Sampe collection; 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).
Controls; Periodontally healthy patients attending the remaining specialty departments ath the same clinic at the point of first diagnosis.	Genetic: Sampe collection; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of virus DNA (HSV1, HSV2, EBV and CMV)	The presence of virus DNA (HSV1, HSV2, EBV and CMV)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking	[Smoking] (smoker, non-smoker) measured through questionnaire at first appointment;	one year
Alcohol consumption	[Alcohol consumption] (yes, no) measured through questionnaire at first appointment;	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.	one year

Collaborators and Investigators

• Sponsor: Miguel de Araújo Nobre
• Collaborators: Egas Moniz - Cooperativa de Ensino Superior, CRL
• Investigators: Study Director: Miguel A de Araújo Nobre, PhD, Malo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: periodontitis; herpes virus
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: HerPerio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: he datasets generated during and/or analysed during the current study will be available upon reasonable request.
• IPD Sharing Time Frame: 8 years
• IPD Sharing Access Criteria: Upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No