Evaluation of Arginine in Periodontal and Cardiovascular Disease

NCT03873948 | Completed DMC

• 1 other identifier: 12-16
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Disorder; Arginine; Hyperaminoaciduria

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment level

  1 year

Study Arms (4)

Control

Healthy patients

Other: Evaluation of arginine serum level

Periodontitis

Patients with periodontal disease

Other: Evaluation of arginine serum level

Cardiovascular

Patients with cardiovascular disease

Other: Evaluation of arginine serum level

Periodontitis+Cardiovascular

Patients with both periodontal and cardiovascular disease

Other: Evaluation of arginine serum level

Interventions

Evaluation of arginine serum level OTHER

correlation of serum arginine level with periodontal and cardiovascular disease

Cardiovascular; Control; Periodontitis; Periodontitis+Cardiovascular

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

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; Amino Acid Metabolism, Inborn Errors

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Assistant Professor

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 14, 2019
• Study Start: January 6, 2014
• Primary Completion: August 8, 2018
• Study Completion: March 1, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: 10 years at least

Locations

IT (1)