LOCAL-DELIVERY OF TETRACYCLINE - FROM CONCEPT TO CLINICAL-APPLICATION

This manuscript reviews the development over the last 20 years of the evidence supporting the clinical application of a controlled delivery device for the treatment of human periodontitis. The device is a monol ithic ethylene vinyl-acetate fibre loaded with 25% w/w tetracycline HC l (tetracycline fibre). It releases tetracycline at a steady state rat e of 2 mu g/cm . h and results in the maintenance of essentially const ant, highly-effective concentrations of tetracycline at the site of ac tion. A series of controlled, randomised, single-blind, phase-III clin ical trials including a total of 463 patients has indicated that: (1) tetracycline fibres result in significantly better outcomes than the s caling and root planing positive control: (2) combination of tetracycl ine fibres with subgingival mechanical debridement results in signific ant improvement over debridement alone. Evidence from these studies ha s led to approval of this treatment modality by the US Food and Drug A dministration and by the European Union Regulatory Bodies. A clinical usage study involving 2711 subjects treated by 68 clinicians in Europe and North America indicated that the magnitude of the observed clinic al outcomes is clinically relevant and that adverse events were rarely observed. A variety of clinical investigations aimed at the optimal i ncorporation of tetracycline fibres in a treatment strategy provide gu idance in case selection. Cost of therapy and concerns of unnecessary usage of antibiotics should be considered. It is nonetheless concluded that combination of tetracycline fibres with mechanical debridement r epresents a documented treatment alternative, the application of which may offer clinical benefits to many patients.