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Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
This study is ongoing, but not recruiting participants.
Study NCT00734708   Information provided by Kaken Pharmaceutical
First Received: August 13, 2008   Last Updated: May 8, 2009   History of Changes

August 13, 2008
May 8, 2009
August 2008
March 2010   (final data collection date for primary outcome measure)
  • rate of increase in alveolar bone height [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]
  • clinical attachment level regained [ Time Frame: 36 weeks after administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734708 on ClinicalTrials.gov Archive Site
  • time course of increase rate in alveolar bone height [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
  • time course of clinical attachment level regained [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
  • time course change of periodontal tissue inspection values [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: No ]
  • occurrence and level of adverse reaction [ Time Frame: within 36 weeks after administration ] [ Designated as safety issue: Yes ]
  • serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
 

This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.

 
Phase III
Interventional
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment
  • Periodontitis
  • Alveolar Bone Loss
  • Periodontal Attachment Loss
  • Drug: Trafermin (genetical recombination)
    Administered to the bone defect during flap operation
    Other Name: KCB-1D
  • Drug: Placebo
    Control
  • A: Experimental
    positive drug (0.3% Trafermin contained)
    Intervention: Drug: Trafermin (genetical recombination)
  • P: Placebo Comparator
    control
    Intervention: Drug: Placebo
Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS ONE. 2008 Jul 2;3(7):e2611.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
300
 
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Probing pocket depth 4mm or deeper
  • Vertical intrabony defect 3 mm or deeper from radiographs at baseline
  • Mobility of tooth 2 degree or less

Exclusion Criteria:

  • Using an investigational drug within the past 24 months
  • Coexisting malignant tumour or history of the same
  • Coexisting diabetes (HbA1C 6.5% or more)
  • Taking bisphosphonates
  • Coexisting gingival overgrowth or history of the same
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00734708
 
KCB-1D-03
Kaken Pharmaceutical
 
Study Director: Chikara Ieda Kaken Pharmaceutical Co., Ltd
Kaken Pharmaceutical
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP