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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014