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NCT04564950 Clinical Trial

Influence of Periodontitis and Coronary Heart Disease on Galectin-3

Periodontal Diseases Clinical Trial

Official title:
Influence of Periodontitis and Coronary Heart Disease on Galectin-3 in Serum and Saliva

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04564950
Other study ID # 18-16-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2016
Est. completion date July 31, 2018

Study information
Verified date September 2020
Source University of Messina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to analyze the association between serum and salivary Galectin-3 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum and salivary Galectin-3 levels

Description:

Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38) were enrolled in the present study. The analyzed sample undergo a demographical, clinical and periodontal evaluation and serological analyses including Endothelin-1 (ET-1) and for serum and salivary Galectin-3 levels.

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date July 31, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers
Gender All
Age group 30 Years to 70 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:
• Observation of serum and salivary Galectin-3 levels
Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices

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 Changes of Clinical Attachment Level (mm) Measurment of changes in Clinical Attachment Level 1-year
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