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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05631288
Other study ID # HerPerio
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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