Alveolar Bone Loss, Periodontal Attachment Loss, Periodontitis
Conditions
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.
Interventions
Administered to the bone defect during flap operation
DRUGPlacebo
Control
Sponsors
Kaken Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of increase in alveolar bone height | 36 weeks after administration |
| clinical attachment level regained | 36 weeks after administration |
Secondary
| Measure | Time frame |
|---|---|
| time course of clinical attachment level regained | within 36 weeks after administration |
| serum anti-Trafermin antibody level | within 4 weeks |
| occurrence and level of adverse reaction | within 36 weeks after administration |
| time course change of periodontal tissue inspection values | within 36 weeks after administration |
| time course of increase rate in alveolar bone height | within 36 weeks after administration |
Countries
Japan
Outcome results
None listed