Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

Phase 2

Completed

• Conditions: Periodontitis
• Interventions: Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

• Registration Number: NCT00514657
• Lead Sponsor: Kaken Pharmaceutical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study Completion: 2004-02
• Status Verified: 2007-08
• Study First Submitted: 2007-08-09
• Study First Submitted QC: 2007-08-09
• Last Update Submitted: 2007-08-09
• Study First Posted: 2007-08-10
• Last Update Posted: 2007-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L	Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)	low dose (0.03 %)
P	Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)	-
M	Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)	medium dose (0.1 %)
H	Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)	high dose (0.3 %)

Primary Outcome Measures

Name	Time	Method
rate of increase in alveolar bone height	36 weeks after administration
clinical attachment level (CAL) regained	36 weeks after administration

Secondary Outcome Measures

Name	Time	Method
time course of rate of increase in alveolar bone height	within 36 weeks after administration
time course of CAL regained	within 36 weeks after administration
the other periodontal inspections (PD, BOP, GI etc.)	within 36 weeks after administration