Preclinical studies of a potential alternative to root canalsurgery have shown effective production of the calcium-richlayer that protects nerves and blood supply to teeth, aUniversity of Michigan School of Dentistry professor reportedat the International Association for Dental Research.
R. Bruce Rutherford studied the morphogenic protein OP-1,which was applied to exposed molar and premolar pulps ofprimates. After six weeks, he said, new dentin formed in allteeth treated with OP-1 in amounts increasing proportionallywith the amount of OP-1 applied. No dentin formed in untreatedteeth or control group subjects.
Creative BioMolecules Inc. (NASDAQ:CBMI) of Hopkinton, Mass.,is collaborating with the University of Michigan and otherinstitutions to evaluate the efficacy of its OP-1 based productin dentin regeneration.
"When dental pulp is exposed, infection can occur that mayrequire the removal of the pulp via root canal surgery," saidCharles Cohen, chairman of Creative BioMolecules. "These datasuggest that an OP-1-based product can be utilized tostimulate the formation of new dentin while maintaining ahealthy tooth, and avoid costly and painful root canal surgery.In the area of tooth dentin alone, we believe OP-1 couldeffectively be used in place of approximately 20 percent, or2.6 million, of the root canal procedures performed annually inthe U.S."
Creative BioMolecules filed an investigational deviceexemption application with FDA for the regeneration of toothdentin in late 1992, and expects to begin clinical trials in thesecond quarter.
Through a long-standing collaboration with Stryker Corp., OP-1is currently in pivotal human studies for bone regeneration innon-union fractures. Creative Biomolecules recently finalizedan agreement with Verax Corp. to acquire a current goodmanufacturing practices facility in Lebanon, N.H., to scale-upproduction of its proprietary morphogenic proteins and growthfactors, particularly lead therapeutics OP-1 and PDGF, forclinical development. -- Nancy Garcia
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