Periodontitis with diabetes
Conditions
Interventions
diabetes with diabetes foot disease with periodontitis group:Clinical routine blood glucose control treatment, combined with periodontal and gingival scaling
diabetes with periodontitis group:Clinical routine blood glucose control treatment, combined with periodontal and gingival scaling
Sponsors
Peking University School of Stomatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 1: Diabetes mellitus with diabetic foot disease and periodontitis group (1) Remaining teeth in the mouth (except the third molar) >=16; (2) Diagnosed with type 2 diabetes, diagnostic criteria for diabetes: Have typical symptoms of diabetes mellitus (including polydipsia, polyuria, polyphagia, unexplained weight loss), plus any of the following 4 items: a) Random blood glucose >=11.1mmol/L; b) fasting blood glucose >=7.0mmol/L; c) Oral glucose tolerance test: 2h blood glucose >=11.1mmol/L; d) Glycosylated hemoglobin > = 6.5%. (3) Confirmed Wagner grade 1-3 diabetic foot disease Foot ulceration and/or deep tissue destruction due to distal lower extremity neuropathy due to diabetes mellitus and/or varying degrees of vascular disease, with or without infection. The details are as follows: a) Wagner grade 1: a superficial ulcer on the foot with no signs of infection. b) Wagner grade 2: deep ulceration of the foot, infection confined to soft tissue, no bone tissue infection or deep abscess. c) Wagner grade 3: deep infection with bone tissue lesions or abscesses. (4) Diagnosed with periodontitis, diagnostic criteria: a) There are obvious plaque, tartar and local irritants, and the degree of inflammation and destruction of periodontal tissue is relatively consistent; b) at least 2 loci probing depth (PD) >=5 mm and attachment loss (AL) >=2 mm, in different quadrants. Group 2: Diabetes mellitus with periodontitis group It only meets the above diagnostic criteria for diabetes and periodontitis, and has no other diabetic complications except for periodontitis.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (1) Pregnant or lactating women; (2) women who plan to become pregnant during the study period; (3) Poor compliance and non-acceptance of enrollment; (4) Acute complications of diabetes mellitus (diabetic ketoacidosis, hyperosmolar hyperglycemic state, diabetic lactic acidosis) within 1 month before screening; (5) Severe chronic complications of diabetes other than diabetic foot disease (such as proliferative diabetic retinopathy or macular degeneration, painful diabetic neuropathy, intermittent claudication) at the time of screening; (6) New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack) within 6 months prior to screening, and assessed by the investigator as not suitable to participate in this clinical trial; (7) Within 6 months prior to screening, the subject has a history of heart disease such as myocardial infarction, coronary angioplasty or bypass, valvular heart disease or heart valve repair, clinically significant unstable angina, uncontrollable arrhythmia or severe heart failure, and is assessed by the investigator as not suitable to participate in this clinical trial; (8) Liver and kidney function impairment, alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the upper limit of normal, and/or total bilirubin more than 1.5 times the upper limit of normal; (9) Severe hypertension that has not been treated at screening or is still poorly controlled after treatment; systolic blood pressure > = 160 mmHg and/or diastolic blood pressure > = 100 mmHg; (10) Presence of severe respiratory, gastrointestinal, hepatic, renal, nervous, psychiatric, hematological, immune system, malignant tumors (except for adequately treated basal cell skin cancer or squamous cell skin cancer) and/or other diseases that may interfere with the results of this study, and are not suitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| probing depth;attachment loss;bleeding index;mobility;bone loss level;Fasting blood glucose;2-hour postprandial blood glucose;glycosylated hemoglobin;C peptide;AGEs;sRAGE;ROS;MDA;Beclin1;ATG5;IL-1ß;calprotectin;Microbial community composition of subgingival plaque; | — |
Countries
China
Contacts
Public ContactXu Li
Peking University School of Stomatology
Outcome results
None listed