Clinical trial NCT01499225: A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change in probing pocket depth (PD)
timeFrame: baseline, 4weeks, 8weeks and 12weeks
Secondary outcomes:
measure: Change in Clinical attachment level (CAL)
timeFrame: baseline, 4weeks, 8weeks and 12weeks
measure: Change in Bleeding on probing(BOP)
timeFrame: baseline, 4weeks, 8weeks and 12weeks
measure: change in Gingival index(GI)
timeFrame: baseline, 4weeks, 8weeks and 12weeks
measure: Change in Plaque index (PI)
timeFrame: baseline, 4weeks, 8weeks and 12weeks
measure: Change in Gingival recession(GR)
timeFrame: baseline, 4weeks, 8weeks and 12weeks
measure: [Exploratory Outcome Measure] Change in Alveolar bone height(ABH)
timeFrame: baseline and 12weeks
measure: [Exploratory Outcome Measure] Change in Alveolar bone density(ABD)
timeFrame: baseline and 12weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Dental Hospital
Study officials:
References:
citation: 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.