Back to resultsTrial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
P
L
M
H
Arm Description
low dose (0.03 %)
medium dose (0.1 %)
high dose (0.3 %)
Outcomes
Primary Outcome Measures
rate of increase in alveolar bone height
clinical attachment level (CAL) regained
Secondary Outcome Measures
time course of rate of increase in alveolar bone height
time course of CAL regained
the other periodontal inspections (PD, BOP, GI etc.)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00514657
Brief Title
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
Official Title
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2 (Randomised Controlled Phase II Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kaken Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P
Arm Type
Placebo Comparator
Arm Title
L
Arm Type
Experimental
Arm Description
low dose (0.03 %)
Arm Title
M
Arm Type
Experimental
Arm Description
medium dose (0.1 %)
Arm Title
H
Arm Type
Experimental
Arm Description
high dose (0.3 %)
Intervention Type
Drug
Intervention Name(s)
Trafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Primary Outcome Measure Information:
Title
rate of increase in alveolar bone height
Time Frame
36 weeks after administration
Title
clinical attachment level (CAL) regained
Time Frame
36 weeks after administration
Secondary Outcome Measure Information:
Title
time course of rate of increase in alveolar bone height
Time Frame
within 36 weeks after administration
Title
time course of CAL regained
Time Frame
within 36 weeks after administration
Title
the other periodontal inspections (PD, BOP, GI etc.)
Time Frame
within 36 weeks after administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Tamura, Ph.D
Organizational Affiliation
Kaken Pharmaceutical Co., Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18596969
Citation
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.
Results Reference
derived
Learn more about this trial
Trial in Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2
We'll reach out to this number within 24 hrs