Clincosm LogoSign in Get a demo

Evaluation of Malondialdehyde in Periodontal and Cardiovascular Disease

Sponsor
University of Messina (Other)
Overall Status
Completed
CT.gov ID
NCT04030286
Collaborator
(none)
133
Enrollment
1
Location
62.9
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
133 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Analysis of Serum and Salivary Malondialdehyde and Lipid Profile Levels in Patients With Periodontal and Cardiovascular Diseases
Actual Study Start Date :
Jan 3, 2014
Actual Primary Completion Date :
Sep 9, 2018
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Control

Healthy patients

Other: Observation
Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease
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
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

Outcome Measures

Primary Outcome Measures

  1. Malondialdehyde levels [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Messina Messina Italy 98125

Sponsors and Collaborators

  • University of Messina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gaetano Isola, DDS, PhD, Junior Assistant Professor, University of Messina
ClinicalTrials.gov Identifier:
NCT04030286
Other Study ID Numbers:
  • 16-12
First Posted:
Jul 23, 2019
Last Update Posted:
Jul 23, 2019
Last Verified:
Jul 1, 2019
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
Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Diseases

Study Results

No Results Posted as of Jul 23, 2019