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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007862
Enrollment
144
Registered
2022-10-31
Start date
2022-11-07
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

None listed

Interventions

Sponsors

Myungin Pharm
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 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

Design outcomes

Primary

MeasureTime frame
Change in GI of Visit 4 compared to Visit 2

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactJi-youn Hong

Kyung Hee University Dental Hospital

periohjy@khu.ac.kr+82-2-958-9380

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026