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临床试验/NCT03809676
NCT03809676已完成不适用

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

Baskent University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
probing depth

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
11 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

probing depth

时间窗: day 1

measured form pocket depth to the gingival margin by periodontal probe

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Sezgin

asistant professor

Baskent University

研究点 (1)

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