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

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ClinicalTrials.gov Identifier: NCT03809676
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yasemin Sezgin, Baskent University

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.

Condition or disease Intervention/treatment
Periodontal Diseases Heart Transplantation Other: periodontal examination

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


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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : January 10, 2019
Actual Study Completion Date : January 10, 2019

Group/Cohort Intervention/treatment
heaart transplant recipients Other: periodontal examination
clinical measurements were recorded

healthy controls Other: periodontal examination
clinical measurements were recorded




Primary Outcome Measures :
  1. probing depth [ Time Frame: day 1 ]
    measured form pocket depth to the gingival margin by periodontal probe



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Ages Eligible for Study:   11 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
40 transplant recipients and 40 systemically healthy patients were recruited
Criteria

For transplant group:

Inclusion criteria:

  • Having heart transplantation surgery
  • be clinically stable

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809676


Locations
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Turkey
Yasemin Sezgin
Ankara, Please Select..., Turkey, 06690
Sponsors and Collaborators
Baskent University

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Responsible Party: Yasemin Sezgin, asistant professor, Baskent University
ClinicalTrials.gov Identifier: NCT03809676     History of Changes
Other Study ID Numbers: BaskentU4
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases