Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

Kaken Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Periodontitis

Treatments: Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514657

KCB-1D-01

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 4 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

L

Experimental group

Description:

low dose (0.03 %)

Treatment:

Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

M

Experimental group

Description:

medium dose (0.1 %)

Treatment:

Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

H

Experimental group

Description:

high dose (0.3 %)

Treatment:

Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)