Creative BioMolecules Inc. has received FDA permission to starttrials of its compound to regenerate the tooth layer, dentin,that protects nerves and blood supply.

The Hopkinton, Mass., company believes the compound, OP-1,may eliminate the need for root canal in 30 percent of cases inwhich vulnerable dental pulp has been exposed by cavities ortooth injury.

Patient enrollment in a pilot clinical study will beginimmediately, said Victor Jegede, vice president for regulatoryaffairs and quality control at Creative BioMolecules. The trialshould determine if patients' treated teeth remain healthy andfully functional, he said.

The treatment is intended to induce formation of new, mineral-rich dentin over exposed pulp, eliminating the risk of infectionand, consequently, the need for extraction and root canal work.

The American Dental Association estimated in 1990 that 14million root canals were performed in the U.S. Preclinicalstudies indicated that the product, based on the morphogenicprotein OP-1, reliably regenerates reparative dentin thatreseals the dental pulp.

"The dentin regeneration product is the first step in a pipelineof products under development," said Charles Cohen, CreativeBioMolecules chairman and chief scientific officer. The products"represent a new approach to dental disorders, treatments thatfocus on regenerative therapies for damaged dental tissues."

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