Influence of Periodontitis and Coronary Heart Disease on Galectin-3
1 other identifier
observational
155
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedFirst Submitted
Initial submission to the registry
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 25, 2020
CompletedDecember 21, 2020
September 1, 2020
2.3 years
September 21, 2020
December 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes of Clinical Attachment Level (mm)
Measurment of changes in Clinical Attachment Level
1-year
Study Arms (4)
Control
Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease
Periodontitis
Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease
Coronary heart disease
Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease
Coronary heart disease + periodontitis
Observation of salivary Galectin-3 levels and correlation of salivary Galectin -3 evels with periodontal disease
Interventions
Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices
Eligibility Criteria
Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38)
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Messina
Messina, 98100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 21, 2020
First Posted
September 25, 2020
Study Start
April 1, 2016
Primary Completion
July 30, 2018
Study Completion
July 31, 2018
Last Updated
December 21, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1-year
- Access Criteria
- Official website
all collected IPD, all IPD that underlie results in a publication