Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

K

Kaken Pharmaceutical

Status and phase

Completed
Phase 2

Conditions

Periodontitis

Treatments

Drug: Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00514657
KCB-1D-01

Details and patient eligibility

About

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.

Enrollment

91 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

91 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems