KCT0007862
Not yet recruiting
未知
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
Myungin Pharm0 sites144 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Myungin Pharm
- Enrollment
- 144
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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