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Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514657
First Posted: August 10, 2007
Last Update Posted: August 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaken Pharmaceutical
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514657


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

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
First Submitted: August 9, 2007
First Posted: August 10, 2007
Last Update Posted: August 10, 2007
Last Verified: August 2007

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


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