Major Cardiovascular Adverse Events (MACE)
Conditions
Interventions
Periodontal Treatment Group:Periodontal Initial Treatment
OHI Group:Oral hygiene instruction
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older (Definition: the patient's age on the day of screening); 2. Patients with generalized stage II-IV periodontitis; 3. Patients with end-stage kidney disease (stage 5 chronic kidney disease); 4. Patients who have received hemodialysis or peritoneal dialysis for 90 days or more; 5. Patients meeting dialysis adequacy (Definition: peritoneal dialysis patients with KT/V >=1.7 per week, hemodialysis patients with KT/V >=1.2 per session are considered to meet dialysis adequacy);
Exclusion criteria
Exclusion criteria: 1.Malignant tumor patients; 2.Edentulous patients; 3.Uncontrolled hypertension (definition: patients with resting sitting blood pressure greater than 160/90mmHg or requiring at least 5 medications to control blood pressure on the day of screening); 4.Patients with uncontrolled diabetes retinopathy or macular disease, resulting in near blindness; 5.Patients planning to undergo kidney transplantation; 6.Patients planning coronary, carotid, or peripheral artery revascularization; 7.Patients undergoing dialysis treatment for acute kidney failure; 8.Individuals with severe bleeding disorders or severe coagulation disorders who are unable to receive periodontal treatment; 9.Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; 10.Received periodontal treatment within the past 12 months; 11.History of myocardial infarction, stroke, hospitalization due to unstable angina pectoris, or transient ischemic attack within the past 3 months; 12.History of myocardial infarction, stroke, hospitalization due to unstable angina pectoris, or transient ischemic attack within the past 3 months Known history of drug/alcohol addiction; 13.Patients who need to frequently change their place of residence due to work or family reasons; 14.Researchers evaluate patients with poor prognosis and an estimated survival period of less than 12 months; 15.Currently participating in other clinical trials;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plaque index;Patient Health Questionnaire-9, PHQ-9;Full mouth probing bleeding index;all-cause mortality;C-reactive protein;KDQOL-SF? V1.3;Attachment loss;Distribution of MACE Event Composition;probing depth; | — |
Countries
China
Contacts
Public ContactZhongchen Song
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed