Evaluation of Arginine in Periodontal and Cardiovascular Disease

Analysis of Serum and Salivary ADMA-Arginine Levels in Patients With Periodontal and Cardiovascular Diseases

Asymmetric dimethylarginine (ADMA) 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 ADMA levels.

Study Overview

• Status: Completed
• Conditions: Metabolic Disorder; Arginine; Hyperaminoaciduria
• Intervention / Treatment: Other: Evaluation of arginine serum level

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thus, for this study, 35 patients with CP, 36 patients with CHD, 35 patients with CP+CHD, and 35 healthy subjects will finally enrolled.

Description

Inclusion Criteria:

• Presence of at least 16 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Attachment level	1 year

Collaborators and Investigators

• Sponsor: University of Messina

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2014
• Primary Completion (ACTUAL): August 8, 2018
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (ACTUAL): March 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases
• Other Study ID Numbers: 12-16 (Other Identifier: Oxford Tropical Research Ethics Committee (OxTREC))

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 Time Frame: 10 years at least
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No