NCT01848379

White Blood Cell Signaling and Defense Mechanisms in Patients With Diabetes Mellitus Type 2 and Periodontitis

Human Polymorphonuclear Neutrophil (PMN) Cytosolic Signaling and Effector Functions in Patients With Diabetes Mellitus Type 2 and Periodontitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Zentrum fuer Zahn-, Mund- und Kieferheilkunde · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 signaling as well as bactericidal effector functions are altered. When diabetic symptoms are corrected by the systemic intervention and treatment of the patients (Anti-diabetic Therapy/ADT, i.e. anti-diabetic medication, diet and dietetic supervision, physiotherapy and physical exercises), white blood cell functions will then normalize and reach the functionality comparable to those cells derived from healthy subjects. Gum diseases like periodontitis have long been associated with and termed complications of uncontrolled diabetes mellitus. Vice versa, after diabetic conditions are corrected, periodontitis treatment will be proven effective, when oral hygiene regimen, full mouth decontamination (FD, i.e. the oral use of topical antiseptics prior and after professional mechanical tooth cleaning, tooth as well as root surface planing, polishing as well as gum and soft tissue decontamination in combination with systemic antibiotics) are performed. To reinforce gum healing, reinfection prevention (RP) as well as supportive periodontal therapy (SPT) will be administered by dental professionals on an individual basis and a detailed schedule. If periodontal pockets critical for participant's self care are not eliminated by FD including RP and SPT, and niches \>5mm after 6 month persist, patients are informed and offered surgical intervention as indicated for gum disease elimination. Dental follow up exams will be offered to all participants.

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 and are reduced or increased when compared to age and gender matched controls 2. To determine the biochemical basis for diabetic PMN alteration of motility as well as bactericidal functions: production of superoxide and release of elastase, respectively 3. To characterize the molecular basis of the observed alterations in the regulation of cytosolic calcium (delta\[Ca2+\]i) and pH (delta\_pHi) exhibited by diabetic PMN 4. To investigate if the pre-activated state and altered bactericidal functionality of diabetic PMN are reversed when the patients' glycemic control is normalized, blood glucose levels as well as periodontal disease are corrected 5. To evaluate, if systemic and periodontal intervention can lead to clinical attachment gain in patients with diabetes mellitus type 2

Conditions

• Chronic Periodontitis
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
PROCEDURE	ADT+FD
PROCEDURE	FD

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-05-07
• Last updated: 2017-07-02

Locations

1 site across 1 country: Germany