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This is a multi-center, randomized, double-blinded, placebo-controlled study to evaluated the efficacy and safety of DKF-306 in patients with periodontal diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DKF-306 | Experimental | During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d. |
|
| Placebo | Placebo Comparator | During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DKF-306 | Drug | Active ingredients |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gingival index from baseline to Week 12 | Weeks 0 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plaque index from baseline to Weeks 4, 8 and 12 | Weeks 0, 4, 8 and 12 | |
| Change in probing pocket depth from baseline to Weeks 4, 8 and 12 | Weeks 0, 4, 8 and 12 | |
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Inclusion Criteria:
Exclusion Criteria:
Hypersensitivity to ingredients of investigational products
Hypersensitivity to Azo dyes, acetylsalicylic acid or other prostaglandin synthase inhibitors
Following diseases or state in the mouth:
Use of orthodontic appliances or removable partial denture(s)
Having teeth or state in need of immediate treatment such as periodontal abscess, a tooth indicated for extraction, etc.
History of aggressive periodontitis or acute necrotizing ulcerative gingivitis
Received dental treatments such as endodontic treatments or periodontal therapy (including both nonsurgical and surgical therapy) within 3 months from randomization
Received the following drugs for more than 2 weeks within 3 months from randomization:
Initiated drugs in treatment of chronic diseases within 3 months from randomization
Received the same drug with investigational products within 3 months from randomization
Medical conditions or diseases affecting the efficacy and safety of investigational products at the investigator's discretion
Heavy smoker (20 cigarettes or more a day)
Pregnant or breast-feeding
Plans to have a child or unwilling to comply with using medically accepted contraception methods during the study
Alcohol or drug abuse
Other investigational products or procedures within 3 months from screening
Not eligible due to other reasons at the investigator's discretion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young-Sung Kim | Contact | +82-2-3010-5987 | dumber73@mail.ulsan.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Youngsung | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Drug |
Placebo |
|
| Change in clinical attachment level from baseline to Weeks 4, 8 and 12 |
| Weeks 0, 4, 8 and 12 |
| Change in bleeding on probing (%) from baseline to Weeks 4, 8 and 12 | Weeks 0, 4, 8 and 12 |
| Change in gingival index from baseline to Weeks 4 and 8 | Weeks 0, 4 and 8 |