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 peri-implantitis
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007861
- Lead Sponsor
- Myungin Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 184
1) Adults 19 years of age or older
2) Implants with a functional load of at least 1 year
3) Those diagnosed with peri-implantitis based on the following criteria. If multiple implants satisfy the following criteria, the implant showing the most severe progression is selected.
? Probing depth =5mm
? BoP and/or pus
? Bone resorption around implant 2mm or more
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) Smokers who smoke more than 10 cigarettes a day
4) Those who have undergone scaling or periodontal treatment within 1 month of screening for selected implant teeth
5) Those who have taken antibiotics, steroids and NSAIDs for 3 days or more within 1 month of screening
6) Those with a history of malignancy within 5 years before screening
7) Those who are determined to be reactive as a result of antibody test (HIV, HCV)
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) Those who cannot quit smoking during this clinical trial period
17) Subjects who participated in other clinical trials within 6 months prior to screening
18) 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 %BoP of Visit 4 compared to Visit 2
- Secondary Outcome Measures
Name Time Method Change in %BoP of Visit 3 compared to Visit 2;Treatment success rate of Visit 3, 4 compared to Visit 2;Change in mPI of Visit 3, 4 compared to Visit 2;Change in mSPI of Visit 3, 4 compared to Visit 2;Change in %SoP of Visit 3, 4 compared to Visit 2;Change in %PPD of Visit 3, 4 compared to Visit 2