Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

This study has been completed.
Sponsor:
Information provided by:
Kaken Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00514657
First received: August 9, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Periodontitis
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)

Further study details as provided by Kaken Pharmaceutical:

Primary Outcome Measures:
  • rate of increase in alveolar bone height [ Time Frame: 36 weeks after administration ]
  • clinical attachment level (CAL) regained [ Time Frame: 36 weeks after administration ]

Secondary Outcome Measures:
  • time course of rate of increase in alveolar bone height [ Time Frame: within 36 weeks after administration ]
  • time course of CAL regained [ Time Frame: within 36 weeks after administration ]
  • the other periodontal inspections (PD, BOP, GI etc.) [ Time Frame: within 36 weeks after administration ]

Enrollment: 91
Study Start Date: December 2001
Study Completion Date: February 2004
Arms Assigned Interventions
Placebo Comparator: P Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Experimental: L
low dose (0.03 %)
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Experimental: M
medium dose (0.1 %)
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Experimental: H
high dose (0.3 %)
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514657

Sponsors and Collaborators
Kaken Pharmaceutical
Investigators
Study Director: Makoto Tamura, Ph.D Kaken Pharmaceutical Co., Ltd
  More Information

No publications provided by Kaken Pharmaceutical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00514657     History of Changes
Other Study ID Numbers: KCB-1D-01
Study First Received: August 9, 2007
Last Updated: August 9, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014