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
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Periodontal Diseases
• Periodontitis

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