HerPerio: Association of Herpesvirus and Periodontitis

Sponsor
Miguel de Araújo Nobre (Other)
Overall Status
Completed
CT.gov ID
NCT05631288
Collaborator
Egas Moniz - Cooperativa de Ensino Superior, CRL (Other)
100
1
35.1
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Sampe collection

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Association of Herpesvirus and Periodontitis: A Clinical and Laboratorial Case-control Study
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Smoking [one year]

    [Smoking] (smoker, non-smoker) measured through questionnaire at first appointment;

  2. Alcohol consumption [one year]

    [Alcohol consumption] (yes, no) measured through questionnaire at first appointment;

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Malo Clinic Lisbon Portugal 1600-042

Sponsors and Collaborators

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

Investigators

  • Study Director: Miguel A de Araújo Nobre, PhD, Maló Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miguel de Araújo Nobre, PhD, Malo Clinic
ClinicalTrials.gov Identifier:
NCT05631288
Other Study ID Numbers:
  • HerPerio
First Posted:
Nov 30, 2022
Last Update Posted:
Nov 30, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Miguel de Araújo Nobre, PhD, Malo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2022