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Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2

NCT ID: NCT00514657

Last Updated: 2007-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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P

Group Type PLACEBO_COMPARATOR

Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Intervention Type DRUG

L

low dose (0.03 %)

Group Type EXPERIMENTAL

Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Intervention Type DRUG

M

medium dose (0.1 %)

Group Type EXPERIMENTAL

Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Intervention Type DRUG

H

high dose (0.3 %)

Group Type EXPERIMENTAL

Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Intervention Type DRUG

Interventions

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Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaken Pharmaceutical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Makoto Tamura, Ph.D

Role: STUDY_DIRECTOR

Kaken Pharmaceutical Co., Ltd.

References

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Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.

Reference Type DERIVED
PMID: 18596969 (View on PubMed)

Other Identifiers

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KCB-1D-01

Identifier Type: -

Identifier Source: org_study_id