Periodontitis
Conditions
Keywords
Trafermin, Periodontitis
Brief summary
This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in order to verify the superiority of Trafermin to placebo, and to determine the recommended therapeutic dose.
Interventions
Sponsors
Kaken Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following criteria: * Alveolar bone defect diagnosed by radiography. * Mobility of teeth must be \<=2 and the width of attached gingiva is suitable for GTR(guided tissue regeneration) method. * Males and females, \>=20 years of age.
Exclusion criteria
Patients will be excluded from the study if any of the following conditions are present: * Concomitant administration of adrenal cortical steroid within 4weeks of treatment in the trial. * Current or previous history of gingival overgrowth by drugs. * Current or previous history of cancer or malignant tumour. * Presence of diabetes mellitus(HbA1c\>=6.5%) * Presence of malnutrition(serum albumin\<=2g/dL) * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of increase in alveolar bone height | 36 weeks after administration |
Secondary
| Measure | Time frame |
|---|---|
| time course of increase rate in alveolar bone height | within 36 weeks after administration |
| time course of clinical attachment level regained | within 36 weeks after administration |
| clinical attachment level regained | 36 weeks after administration |
| serum anti-Trafermin antibody level | within 4 weeks |
| serum Trafermin level | within 24 hours |
| occurrence and level of adverse reaction | within 36 weeks after administration |
Countries
Japan
Outcome results
None listed