Clinical trial NCT00734708: Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Alveolar Bone Loss
Periodontal Attachment Loss
Lead sponsor: Kaken Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 328
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.


Eligibility criteria: Inclusion Criteria:

* Probing pocket depth 4mm or deeper
* Vertical intrabony defect 3 mm or deeper from radiographs at baseline
* Mobility of tooth 2 degree or less

Exclusion Criteria:

* Using an investigational drug within the past 24 months
* Coexisting malignant tumour or history of the same
* Coexisting diabetes (HbA1C 6.5% or more)
* Taking bisphosphonates
* Coexisting gingival overgrowth or history of the same

Primary outcomes:
measure: rate of increase in alveolar bone height
timeFrame: 36 weeks after administration
measure: clinical attachment level regained
timeFrame: 36 weeks after administration
Secondary outcomes:
measure: time course of increase rate in alveolar bone height
timeFrame: within 36 weeks after administration
measure: time course of clinical attachment level regained
timeFrame: within 36 weeks after administration
measure: time course change of periodontal tissue inspection values
timeFrame: within 36 weeks after administration
measure: occurrence and level of adverse reaction
timeFrame: within 36 weeks after administration
measure: serum anti-Trafermin antibody level
timeFrame: within 4 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Kaken Investigational Site
state: Aichi
city: Matsudo
country: Japan
facility: Kaken Investigational Site
state: Chiba
city: Kitakyusyu
country: Japan
facility: Kaken Investigational Site
state: Fukuoka
city: Ishikari-Tobetsu
country: Japan
facility: Kaken Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaken Investigational Site
state: Hokkaido
city: Morioka
country: Japan
facility: Kaken Investigational Site
state: Iwate
city: Machida
country: Japan
facility: Kaken Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Kaken Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Kaken Investigational Site
state: Miyagi
city: Suita
country: Japan
facility: Kaken Investigational Site
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Sinjyuku-ku
country: Japan
facility: Kaken Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Kaken Investigational Site
city: Hiroshima
country: Japan
facility: Kaken Investigational Site
city: Kagoshima
country: Japan
facility: Kaken Investigational Site
city: Nagasaki
country: Japan
facility: Kaken Investigational Site
city: Niigata
country: Japan
facility: Kaken Investigational Site
city: Okayama
country: Japan
facility: Kaken Investigational Site
city: Tokushima
country: Japan
facility: Kaken Investigational Site
Study officials:
affiliation: Kaken Pharmaceutical Co., Ltd.
name: Chikara Ieda
role: STUDY_DIRECTOR
References:
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.