Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514657
• Other study ID #: KCB-1D-01
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2007
• Last updated: August 9, 2007
• Start date: December 2001
• Est. completion date: February 2004

Study information

• Verified date: August 2007
• Source: Kaken Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaken Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of increase in alveolar bone height		36 weeks after administration
Primary	clinical attachment level (CAL) regained		36 weeks after administration
Secondary	time course of rate of increase in alveolar bone height		within 36 weeks after administration
Secondary	time course of CAL regained		within 36 weeks after administration
Secondary	the other periodontal inspections (PD, BOP, GI etc.)		within 36 weeks after administration