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NCT03873948 Clinical Trial

Evaluation of Arginine in Periodontal and Cardiovascular Disease

Metabolic Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03873948
Other study ID # 12-16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 6, 2014
Est. completion date March 1, 2019

Study information
Verified date October 2019
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 141
Est. completion date March 1, 2019
Est. primary completion date August 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Evaluation of arginine serum level
correlation of serum arginine level with periodontal and cardiovascular disease

Locations
Country Name City State
Italy University of Messina Messina

Sponsors (1)
Lead Sponsor Collaborator
University of Messina

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Attachment level 1 year
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