Association of Herpesvirus and Periodontitis

NCT05631288 | Completed

• 1 other identifier: HerPerio
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

periodontitis; herpes virus

Outcome Measures

Primary Outcomes (1)

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

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

  1 day

Secondary Outcomes (3)

• Smoking

  one year

• Alcohol consumption

  one year

• Oral hygiene habits

  one year

Study Arms (2)

Cases

Periodontally compromised patients attending the Periodontology Department during periodontal diagnosis appointments at the point of first diagnosis.

Genetic: Sampe collection

Controls

Periodontally healthy patients attending the remaining specialty departments ath the same clinic at the point of first diagnosis.

Genetic: Sampe collection

Interventions

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).

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Miguel de Araújo Nobre: lead
• Egas Moniz - Cooperativa de Ensino Superior, CRL: collaborator

Study Sites (1)

Malo Clinic

Lisbon, 1600-042, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Unstimulated crevicular fluid samples

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Miguel A de Araújo Nobre, PhD

  Maló Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: November 30, 2022
• Study Start: March 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: February 1, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: 8 years
• Access Criteria: Upon reasonable request

Locations

PT (1)