Periodontitis Clinical Trial
Official title:
A Phase I, Open-Label, Single Center, Safety/Tolerability and Pharmacokinetic Study of Leukine® Administrated in the Gingiva as Three Single Doses on Separate Days
This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Periodontitis is the major cause of tooth loss in people over 35 years of age. An effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.
It is suggested that local administration of GM-CSF in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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