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Completed

NCT Number: NCT00514657

Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed as 2- or 3-walled vertical intrabony defect >=3 mm deep from the top of the remaining alveolar bone
  • with mobility of the tooth of degree 2 or less
  • with width of attached gingiva appropriate for Guided Tissue Regeneration

Exclusion criteria

  • concomitant administration of adrenal cortical steroid within 4 wks after the surgery
  • administeration of calcium antagonist during the 4 weeks preceding administration of the investigational drug
  • coexisting malignant tumour or history of the same
  • coexisting diabetes (HbA1C >= 6.5%)
  • an extremely poor nutritional condition (serum albumin concentration <2 g/dL)
  • pregnancy or lactation

Treatment and study plan

Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Drug

Primary outcomes

  1. rate of increase in alveolar bone height

    Time frame: 36 weeks after administration

  2. clinical attachment level (CAL) regained

    Time frame: 36 weeks after administration

Secondary outcomes

  1. time course of rate of increase in alveolar bone height

    Time frame: within 36 weeks after administration

  2. time course of CAL regained

    Time frame: within 36 weeks after administration

  3. the other periodontal inspections (PD, BOP, GI etc.)

    Time frame: within 36 weeks after administration

Sponsors and collaborators

Lead sponsor

Kaken Pharmaceutical

Industry

Registry information

Official study title

Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)

Important dates

Study start
2001
Study completion
2004
First posted
Aug 10, 2007
Registry last updated
Aug 10, 2007

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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