Researchers present Phase 2 clinical results for Acologix AC-100
Meets goal of stimulating the formation of new dentin, has favorable safety profileToday, researchers from Acologix (Hayward, CA, USA), the University of California (San Francisco, USA), and the University of Connecticut (Simsbury, USA) will announce the results of a Phase 2 clinical trial of AC-100 (also known as Dentonin), reporting that it met its primary goal of stimulating the formation of new dentin when applied directly to tooth defects, and demonstrating that AC-100 has a favorable safety profile.
Administration of AC-100 resulted in a clear trend in stimulating the formation of new dentin, compared with a placebo. This effect was seen across a wide variety of cavity depths. Importantly, the efficacy of AC-100 was seen most dramatically in the deepest cavities (RDT < 0.5 mm), where the clinical utility of the approach is most needed.
Because of its unique hard-tissue-regenerating properties, the researchers believe that AC-100 represents a novel approach to promoting dentin formation and could be a promising treatment for patients undergoing a wide range of dental restoration procedures. Drilling during these procedures can irritate the dental pulp and reduce the dentin layer that protects the pulp, causing pain and sensitivity, and sometimes leading to complications, including tooth loss. Therefore, it may be beneficial to stimulate the formation of new dentin to protect the pulp from this damage.
Results and the method of application of AC-100 used in this Phase 2 clinical study demonstrate that a novel biological approach to dentistry can be introduced as a supplement to routine dental care.
AC-100 is a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells. In addition to dental applications, it is being studied for periodontal, oral bone, dental implant, and orthopedic applications.
This is a summary of Abstract #545, "AC-100, Novel Biological Approach to Promoting Dentin Formation in Humans," by M. Lazarov, J.D. Fellmann, D.M. Rosen, P. DenBesten, and C. Pameijer (Acologix, Hayward, CA, USA; University of California-San Francisco, USA; University of Connecticut, Simsbury, USA), to be presented at 10:45 a.m. on Thursday, June 29, 2006, in the Ballroom Concourse of the Brisbane Convention & Exhibition Centre, during the 84th General Session of the International Association for Dental Research.
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