Association of Herpesvirus and Periodontitis

Completed

• Conditions: Periodontitis
• Interventions: Genetic: Sampe collection

• Registration Number: NCT05631288
• Lead Sponsor: Miguel de Araújo Nobre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-07-31
• Study Completion: 2022-02-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Sampe collection	Periodontally compromised patients attending the Periodontology Department during periodontal diagnosis appointments at the point of first diagnosis.
Controls	Sampe collection	Periodontally healthy patients attending the remaining specialty departments ath the same clinic at the point of first diagnosis.

Primary Outcome Measures

Name	Time	Method
The presence of virus DNA (HSV1, HSV2, EBV and CMV)	1 day	The presence of virus DNA (HSV1, HSV2, EBV and CMV)

Secondary Outcome Measures

Name	Time	Method
Alcohol consumption	one year	\[Alcohol consumption\] (yes, no) measured through questionnaire at first appointment;
Smoking	one year	\[Smoking\] (smoker, non-smoker) measured through questionnaire at first appointment;
Oral hygiene habits	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.

Trial Locations

Locations (1)

Malo Clinic; 🇵🇹 Lisbon, Portugal