A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

A Double-blind, Randomized, Parallel, Placebo-active Controlled, Multi-center Phase II Clinical Trial to Investigate the Efficacy and Safety of YH14642 Following 12-week Oral Administration in Patients With Chronic Periodontal Disease

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.

Inclusion Criteria:

• Subjects must be 20 years of age or older
• Have at least 18 natural teeth
• Four or more clinical attachment level(CAL) ≥ 3mm
• Four or more periodontal pockets with a probing depth (PD) ≥ 4mm
• Have Bleeding on probing
• Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

• Forbidden History of Panax Notoginseng and Rehmanniae Radix Preparata
• Hypersensitivity of Doxycycline
• Hypersensitivity of Zea mays L. extract
• Critical diseases such as HIV previous three years
• Patients with mental retardation and dementia
• Systemic diseases such as diabetes and hypertension
• Patients who take Anticoagulants or Antiplatelet Agents
• Patients who have malignant tumor
• Smoker
• Continually use for 2weeks of phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
• Patients who need malignant tumor
• Patients who received periodontal treatment within the last 6 months
• Pregnant or lactating females