NCT03671408

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

September 13, 2018

Last Update Submit

September 13, 2018

Conditions

Heart Transplant FailurePeriodontitisCrp

Keywords

heart transplantperiodontitishsCRP

Outcome Measures

Primary Outcomes (1)

  • hscrp levels

    serum hscrp levels were compared between the groups

    day 1

Study Arms (2)

periodontitis

periodontitis patients which were diagnosed based on clinical parameters

Other: clinical measurements

gingivitis/healthy

gingivitis healthy patients which were diagnosed based on clinical parameters

Other: clinical measurements

Interventions

clinical measurementsOTHER

only clinical parameters were recorded

Also known as: no intervention was made
gingivitis/healthyperiodontitis

Eligibility Criteria

Age11 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • having other systemic infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asistant professor

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 14, 2018

Study Start

April 20, 2016

Primary Completion

May 20, 2018

Study Completion

June 10, 2018

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share