Periodontitis
Conditions
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.
Interventions
DRUGTrafermin (genetical recombinant of human basic Fibroblast Growth Factor)
Sponsors
Kaken Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of increase in alveolar bone height | 36 weeks after administration |
| clinical attachment level (CAL) regained | 36 weeks after administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed