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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

Tracking Information
First Submitted Date January 17, 2019
First Posted Date January 18, 2019
Last Update Posted Date January 23, 2019
Actual Study Start Date January 9, 2018
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
probing depth [ Time Frame: day 1 ]
measured form pocket depth to the gingival margin by periodontal probe
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03809676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls
Official Title Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 40 transplant recipients and 40 systemically healthy patients were recruited
Condition
  • Periodontal Diseases
  • Heart Transplantation
Intervention Other: periodontal examination
clinical measurements were recorded
Study Groups/Cohorts
  • heaart transplant recipients
    Intervention: Other: periodontal examination
  • healthy controls
    Intervention: Other: periodontal examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2019)
80
Original Actual Enrollment Same as current
Actual Study Completion Date January 10, 2019
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages 11 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03809676
Other Study ID Numbers BaskentU4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yasemin Sezgin, Baskent University
Study Sponsor Baskent University
Collaborators Not Provided
Investigators Not Provided
PRS Account Baskent University
Verification Date January 2019