A Randomized, Double-blind, placebo-controlled, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Igatan F capsule in non-surgical therapy of Chronic periodontitis patients
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007862
- Lead Sponsor
- Myungin Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 144
1) Adults 19 years of age or older
2) Those with at least 16 residual teeth (excluding wisdom teeth and implants)
3) Those diagnosed with stage II or higher periodontitis*
? Radiographic bone loss of more than 15% of the root length
? The deepest periodontal pocket probe depth (PD) is 5 mm or more
? Interdental CAL at the most severe site is 3 mm or more
* 2) If the number of teeth satisfying the criteria ?, ?, ? compared to the number of residual teeth investigated in the standard is 30% or more, it is judged as stage II or higher general periodontitis.
4) A person who voluntarily signed a written informed consent after hearing the explanation of this clinical trial
1) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
2) Patients with uncontrolled diabetes or hypertension (glycated hemoglobin > 8.0% or fasting blood glucose > 200 mg/dl, 160 mmHg = SBP or 100 mmHg = DBP within 3 months of screening)
3) Those who have taken antibiotics, steroids and NSAIDs for 3 days or more within 1 month of screening
4) Those with a history of malignancy within 5 years before screening
5) Those who are determined to be reactive as a result of antibody test (HIV, HCV)
6) Those who have undergone scaling or dental treatment within 1 month of screening
7) Those who have received periodontal treatment other than preventive dental treatment within 6 months of screening
8) Persons with orthodontic appliances or removable local dentures
9) Those with serious pathological findings in the soft tissues of the oral cavity, including oral cancer
10) Those who have 5 or more teeth that require immediate dental caries treatment in the oral cavity
11) Patients with a history of bleeding or disease, or taking antiplatelet or anticoagulant medications
12) hormonal drug users
13) Pregnant or lactating women or women of childbearing age who are unwilling to use appropriate contraceptive methods
14) Those who are taking medications for active peptic ulcer
15) Those who have a history of mental illness or are taking related medications
16) Smokers who smoke more than 10 cigarettes a day
17) Those who cannot quit smoking during this clinical trial period
18) Subjects who participated in other clinical trials within 6 months prior to screening
19) Those who are judged inappropriate to participate in this clinical trial according to the judgment of other researchers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in GI of Visit 4 compared to Visit 2
- Secondary Outcome Measures
Name Time Method Change in GI of Visit 5 compared to Visit 2;Change in %BoP of Visit 4, 5 compared to Visit 2;Change in PD of Visit 4, 5 compared to Visit 2;Change in CAL of Visit 4, 5 compared to Visit 2;Change in PI of Visit 4, 5 compared to Visit 2;Change in 100mm VAS of Visit 4, 5 compared to Visit 2;Change in the number PD =4mm site of Visit 4, 5 compared to Visit 2