Evaluation of Arginine in Periodontal and Cardiovascular Disease

Completed

• Conditions: Metabolic Disorder; Arginine; Hyperaminoaciduria
• Interventions: Other: Evaluation of arginine serum level

• Registration Number: NCT03873948
• Lead Sponsor: University of Messina

Brief Summary

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.

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 Timeline

• Study Start: 2014-01-06
• Primary Completion: 2018-08-08
• Study Completion: 2019-03-01
• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Periodontitis	Evaluation of arginine serum level	Patients with periodontal disease
Control	Evaluation of arginine serum level	Healthy patients
Cardiovascular	Evaluation of arginine serum level	Patients with cardiovascular disease
Periodontitis+Cardiovascular	Evaluation of arginine serum level	Patients with both periodontal and cardiovascular disease

Primary Outcome Measures

Name	Time	Method
Clinical Attachment level	1 year

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy