A Non-Inferiority Study Evaluating Fibroblast Growth Factor-2 (KCB-1D) to Enamel Matrix Derivative (Emdogain(R)Gel) for Periodontal Tissue Regeneration.
- Conditions
- patients with periodontitis who require surgical intervention (flap surgery)
- Registration Number
- JPRN-UMIN000008231
- Lead Sponsor
- KAKEN PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 240
Not provided
1. coexisting with a malignant tumor or history thereof 2. having taken bisphosphonates or coexisting with osteoporosis 3.coexisting with gingival overgrowth or history of the same 4.suspected of a oral malignant/premalignant tumor 5. determined inappropriate for using Emdogain(R)Gel or participating in this study by investigators 6.coexisting with other dental diseases with potential to cause some effects on periodontal healing at the test site (apical periodontitis or root fractures, etc) 7. scheduled to receive surgical, prosthodontic or endodontic treatments at the test site within 36 weeks 8. with dental prosthesis interrupting accurate evaluation of clinical attachment level 9.with bony defects in need of bone grafts, or suspected of severe gingival recession after flap surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method linear alveolar bone growth at 36 weeks after administration
- Secondary Outcome Measures
Name Time Method change of clinical attachment level, probing pocket depth and gingival recession at 36 weeks after administration adverse events and adverse drug reactions