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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809676
• Other study ID #: BaskentU4
• Status: Completed
• Start date: January 9, 2018
• Est. completion date: January 10, 2019

Study information

• Verified date: January 2019
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 10, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplantation
• Periodontal Diseases

Intervention

Other:
• periodontal examination
clinical measurements were recorded

Locations

Country	Name	City	State
Turkey	Yasemin Sezgin	Ankara	Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing depth	measured form pocket depth to the gingival margin by periodontal probe	day 1