White Blood Cell Signaling and Defense Mechanisms in Patients With Diabetes Mellitus Type 2 and Periodontitis (DMS)
Chronic Periodontitis, Diabetes Mellitus, Type 2
About this trial
This is an interventional basic science trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Diabetes Mellitus, Type II
- Glycated Hemoglobin ≥8.5%
- Chronic Periodontitis
- Patients and controls should have at least 12 natural teeth (without subgingival fillings, crowns or caries)
Exclusion Criteria:
- Pregnancy
- Smoking
- Low Body Mass Index (BMI <18.5kg/m*m)
- Severe cardiovascular disease including coronary artery disease, cerebral vascular disease, peripheral vascular disease, valvular heart disease, and congestive heart failure
- Other major illnesses including cancer, liver disease, pulmonary disease, chronic infectious disease other than periodontitis (HIV, hepatitis, etc.), rheumatological disease, hematological disease, or any condition requiring hospitalization or chronic medical therapy other than diabetes.
- Major psychiatric illness requiring treatment, or that might interfere with the ability to understand or cooperate with the protocol
- Ongoing alcohol or drug abuse; all forms of medication or illegal substance abuse
- Systemic enteral or parenteral medication, in part daily vitamin or anti-oxidative supplementation and certain calcium channel blockers (i.e. Nifedipine); but anti diabetic drugs or insulin substitution
- Allergies to antibiotics or adjuvant medication / antiseptics as well as dental materials in use (including gloves) in particular those against topical antiseptic solutions i.e. chlorhexidine / N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] or povidone iodine / 2-Pyrrolidinone, 1-ethenyl-, homopolymer, compound with iodine
- Severe dental disease defined as severe dental caries, and/or severe pulpal disease requiring surgical correction, or any other mucosal or dental condition not readily treated, or requiring extensive dental, oral surgical or prosthetic treatment, or any other oral treatment which could affect the outcome of periodontal therapy or diseases or syndromes that require systemic medication.
- Systemic, topical or inhaled steroid treatment for more than 30 consecutive days within 6 weeks of baseline.
- Any periodontal treatment within 6 months prior to baseline
- For controls: a periodontal screening index (PSI) > 1
Sites / Locations
- Department of Periodontontology, ZentrumZMK
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Antidiabetic Therapy(ADT)+Full Mouth Decontamination(FD)
Full Mouth Deconatamination(FD)
No Treatment
ADT: (Par-)enteral, anti-diabetic medication, diet and dietetic supervision, physiotherapy and physical exercises FD: The oral use of topical antiseptics prior and after mechanical tooth debridement, tooth as well as root surface planing and soft tissue decontamination in combination with systemic antibiotics (a combination of amoxicillin and metronidazole - if no microbial resistances were detected)
FD: The oral use of topical antiseptics prior and after mechanical tooth debridement, tooth as well as root surface planing and soft tissue decontamination in combination with systemic antibiotics (a combination of amoxicillin and metronidazole - if no microbial resistances were detected)
Healthy individuals to be monitored cross-sectional