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Completed

NCT Number: NCT00734708

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

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.

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Key information

Conditions

Periodontitis Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaken Investigational Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trafermin (genetical recombination)

Drug

Administered to the bone defect during flap operation

Other names: KCB-1D

Placebo

Drug

Control

Primary outcomes

  1. rate of increase in alveolar bone height

    Time frame: 36 weeks after administration

  2. clinical attachment level regained

    Time frame: 36 weeks after administration

Secondary outcomes

  1. time course of increase rate in alveolar bone height

    Time frame: within 36 weeks after administration

  2. time course of clinical attachment level regained

    Time frame: within 36 weeks after administration

  3. time course change of periodontal tissue inspection values

    Time frame: within 36 weeks after administration

  4. occurrence and level of adverse reaction

    Time frame: within 36 weeks after administration

  5. serum anti-Trafermin antibody level

    Time frame: within 4 weeks

Sponsors and collaborators

Lead sponsor

Kaken Pharmaceutical

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 14, 2008
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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