Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

Kaken Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Periodontitis; Periodontal Attachment Loss; Alveolar Bone Loss

Treatments: Drug: Trafermin (genetical recombination); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734708

KCB-1D-03

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

positive drug (0.3% Trafermin contained)

Treatment:

Drug: Trafermin (genetical recombination)

P

Placebo Comparator group

Description:

control

Treatment:

Drug: Placebo