Status:
COMPLETED
A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease
Lead Sponsor:
Yuhan Corporation
Conditions:
Chronic Periodontitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01499225
Start Date
December 1 2011
Last Update
July 31 2014
Active Locations (1)
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1
Seoul National University Dental Hospital
Seoul, South Korea