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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01499225

Acronym

YH14642

Enrollment

162

Registered

2011-12-26

Start date

2011-12-31

Completion date

Unknown

Last updated

2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

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.

Interventions

DRUGYH14642 500mg Tab

YH14642 500mg per day(once a day)

DRUGINSADOL[Zea mays L. extract] 35mg Tab

\[Initiation dose : 4weeks after administraion\] 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

DRUGDENTISTA[Doxycycline hyclate] 20mg Cap

DENTISTA\[Doxycycline hyclate\] Cap 40mg per day

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in probing pocket depth (PD)	baseline, 4weeks, 8weeks and 12weeks

Secondary

Measure	Time frame
Change in Bleeding on probing(BOP)	baseline, 4weeks, 8weeks and 12weeks
change in Gingival index(GI)	baseline, 4weeks, 8weeks and 12weeks
Change in Plaque index (PI)	baseline, 4weeks, 8weeks and 12weeks
Change in Clinical attachment level (CAL)	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
Change in Gingival recession(GR)	baseline, 4weeks, 8weeks and 12weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026