Status:
UNKNOWN
White Blood Cell Signaling and Defense Mechanisms in Patients With Diabetes Mellitus Type 2 and Periodontitis
Lead Sponsor:
Zentrum fuer Zahn-, Mund- und Kieferheilkunde
Conditions:
Chronic Periodontitis
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
White blood cell membrane and surface structures are affected by the metabolic disorders and complications found in diabetes mellitus. Therefore, cellular activation, signal propagation, intracellular...
Detailed Description
Specific Aims 1. To investigate if cytosolic Ca2+- ( delta\[Ca2+\]i) and pH (delta\_pHi) signaling responses and bactericidal effector functions of PMN dependent upon the status of diabetic control a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01848379
Start Date
January 1 2012
End Date
December 1 2017
Last Update
July 2 2017
Active Locations (1)
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1
Department of Periodontontology, ZentrumZMK
Giessen, Germany, 35392