Chronic periodontitis with diabetes
Conditions
Interventions
Diabetes mellitus with diabetic foot disease and periodontitis:None
Diabetes mellitus with periodontitis:None
Diabetes mellitus with relatively healthy periodontium:None
Periodontitis only:None
Systemically and periodontally healthy:None
Sponsors
Peking University School of Stomatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group 1 diabetes with diabetes foot disease with periodontitis group (1) There are at least 16 remaining teeth in the mouth (excluding the third molar); (2) Diagnosed as type 2 diabetes, diabetes diagnostic criteria: Have typical symptoms of diabetes (including polydipsia, polyuria, polydipsia, 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: 2-hour blood glucose level >= 11.1mmol/L; d) Glycated hemoglobin >= 6.5%. (3) Diagnosed diabetes foot disease of Wagner 1-3 It has neuropathy at the distal end of the lower limb caused by diabetes and/or foot ulcer and/or deep tissue destruction caused by vascular disease of different degrees, with or without infection. Specifically, as follows: a) Wagner Grade 1: Superficial ulcers on the feet without signs of infection. b) Wagner grade 2: Deep ulcers appear in the feet, with infection limited to soft tissues and no bone tissue infection or deep abscess. c) Wagner grade 3: Deep infection accompanied by bone tissue lesions or abscesses. (4) Diagnosed with periodontitis, diagnostic criteria: a) There are obvious dental plaque, tartar, and local irritants, which are consistent with the degree of inflammation and destruction of periodontal tissue; b) At least 2 sites with probing depth (PD) >= 5 mm, attachment loss (AL) >= 2 mm, and located in different quadrants. Group 2 diabetes with periodontitis group Only the above diagnostic criteria for diabetes and periodontitis are met, and there are no other complications of diabetes except periodontitis. Group 3 diabetes but relatively healthy periodontal group Only the above diagnostic criteria for diabetes are met. Group 4: Simple periodontitis group Only meet the diagnostic criteria for periodontitis mentioned above. Group 5: Whole body and periodontal health group (1) Full body health, no systemic diseases; (2) There are at least 16 remaining teeth in the mouth (excluding the third molar) and no history of tooth loss due to periodontal disease; (3) Full mouth teeth PD2-4mm, no BI >= 3 sites.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women; (2) Women who plan to conceive during the study period; (3) Poor compliance, not accepted for enrollment; (4) Diabetes acute complications (diabetes ketoacidosis, hypertonic hyperglycemia, diabetes lactic acidosis) occurred within 1 month before screening; (5) There are serious chronic complications of diabetes other than diabetes foot disease (such as proliferative diabetes retinopathy or macular disease, painful diabetes neuropathy, intermittent claudication) during screening; (6) Screening for newly occurring cerebrovascular accidents (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within the previous 6 months, and evaluating by the researchers that they are not suitable to participate in this clinical trial; (7) Within the first 6 months of screening, the subject has a history of myocardial infarction, coronary angioplasty or bypass surgery, heart valve disease or heart valve repair surgery, clinically significant unstable angina, uncontrolled arrhythmia or severe heart failure, and has been assessed by the investigator as unsuitable to participate in this clinical trial; (8) Damage to liver and kidney function, with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal values, and/or total bilirubin exceeding 1.5 times the upper limit of normal values; (9) Severe hypertension that has not been treated or is still poorly controlled after treatment during screening; Systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100mmHg; (10) Individuals with severe respiratory, gastrointestinal, liver, kidney, nervous, psychiatric, hematological, immune, malignant tumors (excluding adequately treated basal cell or squamous cell carcinoma) and/or other diseases that may interfere with the results of this study are not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| probing depth;attachment loss;Glucose;glycosylated hemoglobin;C peptide;Advanced Glycation End Products, AGEs;Soluble Receptor for Advanced Glycation End Products, sRAGE;Reactive Oxygen Species, ROS;Malondialdehyde, MDA;Beclin1;ATG5;IL-1ß;calprotectin;GCF-Glucose;GCF-ROS;GCF-Beclin1;GCF-ATG5;GCF- IL-1ß;GCF-calprotectin; | — |
Secondary
| Measure | Time frame |
|---|---|
| bleeding index;mobility;bone loss level;Liver Function;Renal Function;Blood Lipids;Electrolytes; | — |
Countries
China
Contacts
Public ContactXu Li
Peking University School of Stomatology
Outcome results
None listed