Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

August 9, 2007 updated by: Kaken Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Experimental: L
low dose (0.03 %)
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Experimental: M
medium dose (0.1 %)
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Experimental: H
high dose (0.3 %)
Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of increase in alveolar bone height
Time Frame: 36 weeks after administration
36 weeks after administration
clinical attachment level (CAL) regained
Time Frame: 36 weeks after administration
36 weeks after administration

Secondary Outcome Measures

Outcome Measure
Time Frame
time course of rate of increase in alveolar bone height
Time Frame: within 36 weeks after administration
within 36 weeks after administration
time course of CAL regained
Time Frame: within 36 weeks after administration
within 36 weeks after administration
the other periodontal inspections (PD, BOP, GI etc.)
Time Frame: within 36 weeks after administration
within 36 weeks after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaken Pharmaceutical

Investigators

  • Study Director: Makoto Tamura, Ph.D, Kaken Pharmaceutical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

August 9, 2007

First Submitted That Met QC Criteria

August 9, 2007

First Posted (Estimate)

August 10, 2007

Study Record Updates

Last Update Posted (Estimate)

August 10, 2007

Last Update Submitted That Met QC Criteria

August 9, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCB-1D-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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