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Completed

NCT Number: NCT01499225

A Clinical Trial of YH14642 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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Dental Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH14642 500mg Tab

Drug

YH14642 500mg per day(once a day)

INSADOL[Zea mays L. extract] 35mg Tab

Drug

[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] 20mg Cap

Drug

DENTISTA[Doxycycline hyclate] Cap 40mg per day

Placebo

Drug

Placebo

Primary outcomes

  1. Change in probing pocket depth (PD)

    Time frame: baseline, 4weeks, 8weeks and 12weeks

Secondary outcomes

  1. Change in Clinical attachment level (CAL)

    Time frame: baseline, 4weeks, 8weeks and 12weeks

  2. Change in Bleeding on probing(BOP)

    Time frame: baseline, 4weeks, 8weeks and 12weeks

  3. change in Gingival index(GI)

    Time frame: baseline, 4weeks, 8weeks and 12weeks

  4. Change in Plaque index (PI)

    Time frame: baseline, 4weeks, 8weeks and 12weeks

  5. Change in Gingival recession(GR)

    Time frame: baseline, 4weeks, 8weeks and 12weeks

  6. [Exploratory Outcome Measure] Change in Alveolar bone height(ABH)

    Time frame: baseline and 12weeks

  7. [Exploratory Outcome Measure] Change in Alveolar bone density(ABD)

    Time frame: baseline and 12weeks

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Acronym: YH14642

Important dates

Study start
2011
Primary completion
2013
First posted
Dec 26, 2011
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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