NCT03671408

Brief Summary

Inflammation plays a key role in the deterioration of chronic heart transplants. Periodontal disease is not limited to the tooth-supporting structures - it also contributes to systemic inflammation. This study explored whether periodontitis is associated with serum high-sensitivity C-reactive protein (hs-CRP) levels in heart transplant patients. The study included 33 patients who had undergone heart transplantation at Baskent University Hospital. Clinical periodontal parameters were recorded, and blood samples were collected on the same day to measure serum hs-CRP.

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

August 4, 2026

Status Verified

August 1, 2026

Enrollment Period

2.1 years

First QC Date

September 13, 2018

Last Update Submit

August 2, 2026

Conditions

CrpHeart Transplant FailurePeriodontitis

Keywords

heart transplantperiodontitishsCRP

Outcome Measures

Primary Outcomes (1)

  • hs-CRP levels

    Serum hs-CRP levels were compared between the groups (periodontitis vs. periodontally healthy vs. gingivitis)

    Day 1

Study Arms (2)

gingivitis/healthy

Description: "gingivitis healthy patients which were diagnosed based on clinical parameters

Other: clinical measurements

periodontitis

periodontitis patients which were diagnosed based on clinical parameters

Interventions

clinical measurementsOTHER

only clinical parameters were recorded

Also known as: no intervention was made
gingivitis/healthy

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:

  • Patients who underwent heart transplant procedures at Baskent University Hospital

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
Associate 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

August 4, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share