Antibiotic Fibers to Treat Gum Disease to Be Marketed In U.S.

BUFFALO, N.Y. -- Antibiotic-containing fibers capable of delivering 60-100 times the amount of medication to infected gum tissue than can be delivered with oral medication have been cleared for marketing in the United States.

The fibers were clinically tested at several U.S. dental centers, including the University at Buffalo School of Dental Medicine.

Marketed under the name Actisite, the ethylene vinyl acetate (EVA) copolymer fibers containing the antibiotic tetracycline hydrochloride (Actisite) are manufactured by ALZA Corp. in Palo Alto, Calif., and marketed jointly by ALZA and Proctor & Gamble.

Sebastian G. Ciancio, D.D.S., chair and professor of periodontics who headed the UB study, said that systemically delivered tetracycline sometimes is prescribed in conjunction with non-surgical root scaling and planing, as well as periodontal surgery. The antibiotic is effective against several oral bacteria that are major culprits in periodontal (gum) disease.

Ciancio and his colleagues implanted the Actisite fibers -- each containing 12.5 milligram of antibiotic per fiber -- and a placebo fiber in two non-adjacent periodontal pockets of 5 mm depth or greater around affected teeth in 10 patients three weeks after root planing and scaling.

All of the fibers were removed seven days later, except those that were self-expelled in two patients. Periodontal surgery was then performed.

Ciancio and his colleagues reported two years ago in the Journal of Periodontology that the fibers did not interfere with healing after surgery in the 10 patients.

"Mechanical and chemical removal of colonies of the disease-causing bacteria reduces their numbers and reduces pocket depth around teeth to allow more effective brushing and flossing after treatment," says Ciancio.

The only adverse side effect of the placement of both tetracycline and placebo fibers was some discomfort -- reported in two of the patients.

Other centers involved in various Actisite studies are Forsyth Dental Center in Boston; the University of Minnesota; University of Missouri at Kansas City; Eastman Dental Center in Rochester, N.Y.; the University of Alabama at Birmingham, and Emory University.