A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan

A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and the Safety of Trafermin in Patients With Marginal Periodontitis in Japan

This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in order to verify the superiority of Trafermin to placebo, and to determine the recommended therapeutic dose.

Inclusion Criteria:

The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following criteria:

• Alveolar bone defect diagnosed by radiography.
• Mobility of teeth must be <=2 and the width of attached gingiva is suitable for GTR(guided tissue regeneration) method.
• Males and females, >=20 years of age.

Exclusion Criteria:

Patients will be excluded from the study if any of the following conditions are present:

• Concomitant administration of adrenal cortical steroid within 4weeks of treatment in the trial.
• Current or previous history of gingival overgrowth by drugs.
• Current or previous history of cancer or malignant tumour.
• Presence of diabetes mellitus(HbA1c>=6.5%)
• Presence of malnutrition(serum albumin<=2g/dL)
• Pregnancy or lactation