Overview

Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
Summary
The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kaken Pharmaceutical
Treatments:
Mitogens
Criteria
Inclusion Criteria:

- diagnosed as 2- or 3-walled vertical intrabony defect >=3 mm deep from the top of the
remaining alveolar bone

- with mobility of the tooth of degree 2 or less

- with width of attached gingiva appropriate for Guided Tissue Regeneration

Exclusion Criteria:

- concomitant administration of adrenal cortical steroid within 4 wks after the surgery

- administeration of calcium antagonist during the 4 weeks preceding administration of
the investigational drug

- coexisting malignant tumour or history of the same

- coexisting diabetes (HbA1C >= 6.5%)

- an extremely poor nutritional condition (serum albumin concentration <2 g/dL)

- pregnancy or lactation