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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015404

Enrollment

Registered

2009-11-18

Start date

2009-11-30

Completion date

Unknown

Last updated

2013-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

Trafermin, Periodontitis

Brief summary

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

Interventions

DRUGTrafermin

Administered to the bone defect during flap operation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
serum Trafermin level	within 4 weeks

Secondary

Measure	Time frame
occurrence and level of adverse reaction	within 4 weeks
serum anti-Trafermin antibody level	within 4 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026