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

NCT00734708 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2012-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Periodontitis
  • Alveolar Bone Loss
  • Periodontal Attachment Loss

Interventions

DRUG

Trafermin (genetical recombination)

Administered to the bone defect during flap operation

DRUG

Placebo

Control

Sponsors & Collaborators

  • Kaken Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Chikara Ieda · Kaken Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-03-31

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734708 on ClinicalTrials.gov