Trial | NCT00514657  Report issue

Title

Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    trafermin ...

  • Study Participants

    91
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.
Study Started
Dec 31
2001
Study Completion
Feb 29
2004
Last Update
Aug 10
2007
Estimate

Drug Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

P Placebo Comparator

L Experimental

low dose (0.03 %)

M Experimental

medium dose (0.1 %)

H Experimental

high dose (0.3 %)

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
No Results Posted