Influence of Periodontitis and Coronary Heart Disease on Galectin-3

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

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

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Other: Observation of serum and salivary Galectin-3 levels

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98100
    • University of Messina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease	Other: Observation of serum and salivary Galectin-3 levels; Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices
Periodontitis; Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease	Other: Observation of serum and salivary Galectin-3 levels; Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices
Coronary heart disease; Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease	Other: Observation of serum and salivary Galectin-3 levels; Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices
Coronary heart disease + periodontitis; Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease	Other: Observation of serum and salivary Galectin-3 levels; Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Clinical Attachment Level (mm)	Measurment of changes in Clinical Attachment Level	1-year

Collaborators and Investigators

• Sponsor: University of Messina

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stomatognathic Diseases; Mouth Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Periodontitis; Periodontal Diseases
• Other Study ID Numbers: 18-16-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: 1-year
• IPD Sharing Access Criteria: Official website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No