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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Heart Transplantation
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Please Select...
    • Ankara, Please Select..., Turkey, 06690
      • Yasemin Sezgin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

40 transplant recipients and 40 systemically healthy patients were recruited

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy controls	Other: periodontal examination; clinical measurements were recorded
heaart transplant recipients	Other: periodontal examination; clinical measurements were recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth	measured form pocket depth to the gingival margin by periodontal probe	day 1

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): January 10, 2019
• Study Completion (Actual): January 10, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 19, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: BaskentU4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No