None listed
Conditions
Interventions
Dietary Supplement : 1. Daily intake and method • Test group
(DSE01): take 2 tablets twice a day (1000mg/day as Ecklonia cava Kjellman
extract) • Placebo: take placebo tablets in the same way as the
Sponsors
Duksung Women's University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male and female under 20 years old and under 75 years old 2) Those who have 10% or more of BOP (Bleeding on probing) site in all teeth and 1 or more teeth with PD (Probing Depth) of more than 3mm and 5mm or less 3) Those who have at least 18 existing natural teeth (excluding implants) 4) A person who has signed the Informed Consent Form before the test begins
Exclusion criteria
Exclusion criteria: 1) Those who received scaling treatment and preventive periodontal treatment within 3 months of Visit 1 2) People with a history of hemorrhagic disease or disease, or those taking antiplatelet or anticoagulant drugs to prevent them 3) Those with severe pathological findings in the soft tissues of the oral cavity (oral cancer patients) 4) Those who have 5 or more target teeth to be treated immediately for dental caries 5) Periodontitis patients requiring surgery or acute treatment 6) Smokers who smoke more than 10 cigarettes a day 7) Those who took antibiotics within 2 weeks of Visit 1 8) Diabetes patients whose blood sugar is not controlled (over 180mg/dl of blood sugar when fasting) 9) Those whose AST(GOT) or ALT(GPT) is 3 times or more than the normal upper limit of the test institution 10) Those whose Creatinine is more than twice the normal upper limit of the test institution 11) Patients with clinically significant cardiovascular, immune system, infectious and oncological diseases 12) People with mental illness such as schizophrenia, depression, drug addiction, alcoholism 13) Those who are allergic to the main ingredients of the food for testing 14) Those who are pregnant or who are planning to become pregnant or lactating during this human trial 15) Persons who participated in other interventional clinical trials (including human trials) within one month of Visit 1 or plan to participate in other interventional trials (including human trials) after the start of this human trial. 16) A person who is inappropriate for this human application test by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gingival index | — |
Secondary
| Measure | Time frame |
|---|---|
| probing depth;clinical attachment level;plaque index;bleeding on probing;Gingival recession;Biomarkers in sulcular fluid;Oral Health Impact Profile -14 | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Yun SHIN
Kyung Hee University Dental Hospital
Outcome results
None listed