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This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH14642 A-I | Experimental |
| |
| YH14642 A-II | Experimental |
| |
| YH14642 A-III | Experimental |
| |
| Active Comparator B | Active Comparator |
| |
| Active Comparator C | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH14642 500mg Tab | Drug | YH14642 500mg per day(once a day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in probing pocket depth (PD) | baseline, 4weeks, 8weeks and 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical attachment level (CAL) | baseline, 4weeks, 8weeks and 12weeks | |
| Change in Bleeding on probing(BOP) | baseline, 4weeks, 8weeks and 12weeks | |
| change in Gingival index(GI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Dental Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33197289 | Derived | Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2. |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| YH14642 500mg Tab |
| Drug |
YH14642 1000mg per day(twice a day) |
|
| YH14642 500mg Tab | Drug | YH14642 2000mg per day(three times a day) |
|
| INSADOL[Zea mays L. extract] 35mg Tab | Drug | [Initiation dose : 4weeks after administraion] INSADOL[Zea mays L. extract] 210mg TAB per day [Maintain dose : Between 4weeks and 8weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day [Maintain dose : Between 8weeks and 12weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day |
|
| DENTISTA[Doxycycline hyclate] 20mg Cap | Drug | DENTISTA[Doxycycline hyclate] Cap 40mg per day |
|
| Placebo | Drug | Placebo |
|
| baseline, 4weeks, 8weeks and 12weeks |
| Change in Plaque index (PI) | baseline, 4weeks, 8weeks and 12weeks |
| Change in Gingival recession(GR) | baseline, 4weeks, 8weeks and 12weeks |
| [Exploratory Outcome Measure] Change in Alveolar bone height(ABH) | baseline and 12weeks |
| [Exploratory Outcome Measure] Change in Alveolar bone density(ABD) | baseline and 12weeks |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |