Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients

Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients With and Without Periodontitis

Objectives: The outcomes of heart transplantation are very favorable but inflammation still plays a critical role in deterioration of chronic transplants. Periodontal diseases are not only limited to supporting structures of the teeth, they also cause systemic inflammation. Based on the importance of inflammation in heart transplant recipients and the association between periodontal disease and systemic inflammation, this study explored whether periodontitis may be a modifier of serum high-sensitivity C-reactive protein (HsCRP) in heart transplant patients.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Heart Transplant Failure; Crp
• Intervention / Treatment: Other: clinical measurements

• Study Type: Observational
• Enrollment (Actual): 33

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients who underwent heart transplant between 2004 and April 2016 at Baskent University Hospital,will be asked to participate in the study during routine outpaient visits at Baskent University Hospital

Description

Inclusion Criteria:

be clinically stable be at least 1 year post-transplant; no history of antibiotic use during the preceding 4 months have had no periodontal treatment within the previous year.

Exclusion Criteria:

having other systemic infections

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
periodontitis; periodontitis patients which were diagnosed based on clinical parameters	Other: clinical measurements; only clinical parameters were recorded; Other Names: no intervention was made
gingivitis/healthy; gingivitis healthy patients which were diagnosed based on clinical parameters	Other: clinical measurements; only clinical parameters were recorded; Other Names: no intervention was made

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hscrp levels	serum hscrp levels were compared between the groups	day 1

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2016
• Primary Completion (Actual): May 20, 2018
• Study Completion (Actual): June 10, 2018

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: periodontitis; heart transplant; hsCRP
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: BaskentU3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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