Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
1 other identifier
interventional
91
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 10, 2007
CompletedAugust 10, 2007
August 1, 2007
August 9, 2007
August 9, 2007
Conditions
Outcome Measures
Primary Outcomes (2)
rate of increase in alveolar bone height
36 weeks after administration
clinical attachment level (CAL) regained
36 weeks after administration
Secondary Outcomes (3)
time course of rate of increase in alveolar bone height
within 36 weeks after administration
time course of CAL regained
within 36 weeks after administration
the other periodontal inspections (PD, BOP, GI etc.)
within 36 weeks after administration
Study Arms (4)
P
PLACEBO COMPARATORL
EXPERIMENTALlow dose (0.03 %)
M
EXPERIMENTALmedium dose (0.1 %)
H
EXPERIMENTALhigh dose (0.3 %)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 18596969DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Makoto Tamura, Ph.D
Kaken Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2007
First Posted
August 10, 2007
Study Start
December 1, 2001
Study Completion
February 1, 2004
Last Updated
August 10, 2007
Record last verified: 2007-08