NCT03809676

Brief Summary

Forty heart transplant recipients and forty age and sex mathced systemically healthy patients were included. Periodontal examination was performed and a questionnaire was applied to record demographic data, systemic health and dental behavior data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 9, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 17, 2019

Last Update Submit

January 19, 2019

Conditions

Periodontal DiseasesHeart Transplantation

Outcome Measures

Primary Outcomes (1)

  • probing depth

    measured form pocket depth to the gingival margin by periodontal probe

    day 1

Study Arms (2)

heaart transplant recipients

Other: periodontal examination

healthy controls

Other: periodontal examination

Interventions

periodontal examinationOTHER

clinical measurements were recorded

heaart transplant recipientshealthy controls

Eligibility Criteria

Age11 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

40 transplant recipients and 40 systemically healthy patients were recruited

You may qualify if:

  • Having heart transplantation surgery
  • be clinically stable

You may not qualify if:

  • History of periodontal treatment within the previous year,
  • history of antibiotic use during the preceding 6 months,
  • being systemically healthy
  • no history of periodontal treatment within the previous year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin Sezgin

Ankara, Please Select..., 06690, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asistant professor

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 18, 2019

Study Start

January 9, 2018

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)