patients with periodontitis who require surgical intervention (flap surgery)
Conditions
Interventions
KCB-1D group Adequate volume of KCB-1D will be administered to the lesion during flap surgery.
EMD group Adequate volume of Emdogain(R)Gel will be administered to the lesion during flap surgery.
Sponsors
KAKEN PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.diagnosed as periodontitis requiring flap surgery after successful initial preparation 2.with vertical intrabony defect 4 mm or deeper on radiographs 3.with probing pocket depth 6 mm or deeper, with mobility of tooth 2 degree or less, and with width of keratinized gingiva for which flap surgery is considered appropriate
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| linear alveolar bone growth at 36 weeks after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| change of clinical attachment level, probing pocket depth and gingival recession at 36 weeks after administration adverse events and adverse drug reactions | — |
Countries
Japan
Contacts
Public ContactMotoki Akamatsu
KAKEN PHARMACEUTICAL CO., LTD. Clinical Development Department
Outcome results
None listed