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Evaluation of Arginine in Periodontal and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT03873948
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gaetano Isola, DDS, PhD, 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.

Condition or disease Intervention/treatment
Metabolic Disorder Arginine; Hyperaminoaciduria 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.

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Analysis of Serum and Salivary ADMA-Arginine Levels in Patients With Periodontal and Cardiovascular Diseases
Actual Study Start Date : January 6, 2014
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : March 1, 2019


Group/Cohort Intervention/treatment
Control
Healthy patients
Other: Evaluation of arginine serum level
correlation of serum arginine level with periodontal and cardiovascular disease

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

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




Primary Outcome Measures :
  1. Clinical Attachment level [ Time Frame: 1 year ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873948


Locations
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Italy
University of Messina
Messina, Italy, 98125
Sponsors and Collaborators
University of Messina

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Responsible Party: Gaetano Isola, DDS, PhD, Junior Assistant Professor, University of Messina
ClinicalTrials.gov Identifier: NCT03873948     History of Changes
Other Study ID Numbers: 12-16
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD, all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Analytic Code
Time Frame: 10 years at least

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Cardiovascular Diseases