Evaluation of Malondialdehyde in Periodontal and Cardiovascular Disease

July 19, 2019 updated by: Gaetano Isola, DDS, PhD, University of Messina

Analysis of Serum and Salivary Malondialdehyde and Lipid Profile Levels in Patients With Periodontal and Cardiovascular Diseases

Malondialdehyde (MDA) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (CHD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum MDA levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to evaluate a possible association between both saliva and serum MDA levels in patients with CP and with CHD and if the serum MDA levels are mediated by serum CRP

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Messina, Italy, 98125
        • University of Messina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

32 healthy subjects, 34 patients with CP, 33 patients with CHD and 34 patients with CP and CHD. Lipid profile and levels of MDA and C-reactive protein (CRP) were evaluated.

Description

Inclusion Criteria:

  • Presence of at least twenty teeth

  • CP with a minimum of 40% of sites with a clinical attachment level (CAL)

    ≥2mm and probing depth (PD) ≥4mm;

  • Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
  • Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

  • Intake of contraceptives
  • Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
  • Status of pregnancy or lactation
  • Previous history of excessive drinking
  • Allergy to local anaesthetic
  • Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periodontitis
Patients with periodontal disease
Other: Observation
Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease
Cardiovascular
Patients with cardiovascular disease
Other: Observation
Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease
Control
Healthy patients
Other: Observation
Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease
Periodontitis+Cardiovascular
Patients with both periodontal and cardiovascular disease
Other: Observation
Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Malondialdehyde levels
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Messina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2014

Primary Completion (Actual)

September 9, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Disease

Clinical Trials on Observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe