A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)

Kaken Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Periodontitis

Treatments: Drug: Trafermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01015404

KCB-1D-04

Details and patient eligibility

About

This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.

Enrollment: 25 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vertical intrabony defect from radiographs at baseline
• Age of 20 years or older

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: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Experimental H

Experimental group

Description:

high volume (0.6mL、0.3% Trafermin)

Treatment:

Drug: Trafermin

Experimental L

Experimental group

Description:

low volume (0.2mL、0.3% Trafermin)

Treatment:

Drug: Trafermin