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CompletedNCT03809676Updated Jan 23, 2019

Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls

An observational study in Periodontal Diseases and Heart Transplantation, sponsored by Baskent University. Completed at 1 site in Turkey. Open to participants aged 11 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Baskent University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
11 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Patients who had heart transplantion surgery at between 2003 to 2017 were screened during routine outpatient visits. The patients who have history of periodontal treatment within the previous year, history of antibiotic use during the preceding 6 months, clinically non-stable patients were excluded . 40 cardiac transplant patiets who met these criteria included into this study. Each member of the transplant group was mathched with a patient in the systemically healthy control group by age and gender and smoking status. 40 systemically healthy subjects with no history of periodontal treatment within the previous year and no history of antibiotic use during the preceding 6 months were recruited.

Medical Data Hospital records were reviewed and data were collected using a standardised form that included demographic information (age, gender) and medical information such as smoking history, presence of systemic disease, post transplant time, medication regimen/dosages. Assesment of Oral Hygeine Behaviour Patients were also asked to complete a standardised anamnestic questionnaire. Questions were about their personal oral hygeine behaviour (toothbrush, dental floss etc.), whether their dental visit was routine or complaint-oriented. For the transplant group one more question about whether a dental check up or comprehensive dental treatment had occured before transplantation was added.

Clinical Examination In both groups, periodontal examination was performed by one calibrated periodontist at the Deperatment of Periodontology, Başkent University. All subjects recieved a comprehensive periodontal examination including plaque index (PI); gingival index (GI); gingival recession (GR); bleeding on probing (BOP); Probing depth (PD); clinical attachment level (CAL).

According to the clinical and radiographic evaluation the patients were categorized due to their periodontal status. The patients were diagnosed with periodontally healthy, gingivitis or periodontitis. Patients were diagnosed with periodontally healthy if they have \<10% bleeding sites with probing depths ≤3 mm; whereas patients who have >10% bleeding sites with probing depths ≤3 mm were diagnosed with gingivitis. Patients who had probing depths ≥ 4 mm, interproximal, CAL of ≥2 mm or ≥3 mm at ≥2 non-adjacent teeth .9,25,26

02

Conditions studied

  • Periodontal Diseases
  • Heart Transplantation

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03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Baskent University is the lead sponsor of 201 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

40 transplant recipients and 40 systemically healthy patients were recruited

For transplant group:

Inclusion criteria

Inclusion criteria:

  • Having heart transplantation surgery
  • be clinically stable

Exclusion criteria

Exclusion criteria

  • History of periodontal treatment within the previous year,
  • history of antibiotic use during the preceding 6 months,
  • being clinically non-stable For healthy group Inclusion criteria
  • being systemically healthy
  • no history of periodontal treatment within the previous year
  • no history of antibiotic use during the preceding 6 months exclusion criteria Having a systemic disease
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • heaart transplant recipients

    Other: periodontal examination

  • healthy controls

    Other: periodontal examination

Interventions

  • Otherperiodontal examination

    clinical measurements were recorded

06

What researchers measure

Primary outcomes

  1. probing depth

    measured form pocket depth to the gingival margin by periodontal probe

    Time frame: day 1

07

Study locations

1 site
  • Yasemin Sezgin
    Ankara, Please Select... 06690, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03809676
Lead sponsor
Baskent University
Responsible party
Yasemin Sezgin (asistant professor, Baskent University) — Principal investigator
First posted
Jan 18, 2019
Start date
Jan 9, 2018
Primary completion
Jan 10, 2019
Completion
Jan 10, 2019
Last update
Jan 23, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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