Evaluation of Malondialdehyde in Periodontal and Cardiovascular Disease

NCT04030286 | Completed DMC

• 1 other identifier: 16-12
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (1)

• Malondialdehyde levels

  1 year

Study Arms (4)

Control

Healthy patients

Other: Observation

Periodontitis

Patients with periodontal disease

Other: Observation

Cardiovascular

Patients with cardiovascular disease

Other: Observation

Periodontitis+Cardiovascular

Patients with both periodontal and cardiovascular disease

Other: Observation

Interventions

Observation OTHER

Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease

Cardiovascular; Control; Periodontitis; Periodontitis+Cardiovascular

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Assistant Professor

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: January 3, 2014
• Primary Completion: September 9, 2018
• Study Completion: April 1, 2019
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)