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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
YH14642 500mg per day(once a day)
YH14642 1000mg per day(twice a day)
YH14642 2000mg per day(three times a day)
Seoul National University Dental Hospital
Seoul, South Korea
Change in probing pocket depth (PD)
Time frame: baseline, 4weeks, 8weeks and 12weeks
Change in Clinical attachment level (CAL)
Time frame: baseline, 4weeks, 8weeks and 12weeks
Change in Bleeding on probing(BOP)
Time frame: baseline, 4weeks, 8weeks and 12weeks
change in Gingival index(GI)
Time frame: baseline, 4weeks, 8weeks and 12weeks
Change in Plaque index (PI)
Time frame: baseline, 4weeks, 8weeks and 12weeks
Change in Gingival recession(GR)
Time frame: baseline, 4weeks, 8weeks and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone height(ABH)
Time frame: baseline and 12weeks
[Exploratory Outcome Measure] Change in Alveolar bone density(ABD)
Time frame: baseline and 12weeks
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\[Initiation dose : 4weeks after administraion\] 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\[Doxycycline hyclate\] Cap 40mg per day
Placebo