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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaken Pharmaceutical

Criteria

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