Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 - Full Text View

Sponsored by:	Kaken Pharmaceutical
Information provided by:	Kaken Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00514657

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 II

Drug Information available for: Trafermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
P: Placebo Comparator	Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
L: Experimental low dose (0.03 %)	Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
M: Experimental medium dose (0.1 %)	Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
H: Experimental 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

Publications indexed to this study:

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.

Study ID Numbers:	KCB-1D-01
Study First Received:	August 9, 2007
Last Updated:	August 9, 2007
ClinicalTrials.gov Identifier:	NCT00514657
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Mouth Diseases
Periodontal Diseases
Periodontitis
Stomatognathic Diseases

ClinicalTrials.gov processed this record on January 16, 2009