Association of Herpesvirus and Periodontitis

Periodontitis Clinical Trial

— HerPerio  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631288
• Other study ID #: HerPerio
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: November 2022
• Source: Malo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2022
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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).

Locations

Country	Name	City	State
Portugal	Malo Clinic	Lisbon

Sponsors (2)

Lead Sponsor	Collaborator
Miguel de Araújo Nobre	Egas Moniz - Cooperativa de Ensino Superior, CRL

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of virus DNA (HSV1, HSV2, EBV and CMV)	The presence of virus DNA (HSV1, HSV2, EBV and CMV)	1 day
Secondary	Smoking	[Smoking] (smoker, non-smoker) measured through questionnaire at first appointment;	one year
Secondary	Alcohol consumption	[Alcohol consumption] (yes, no) measured through questionnaire at first appointment;	one year
Secondary	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