Clinical evaluation of extract of Ecklonia cava Kjellman on gingival health
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0005397
- Lead Sponsor
- Duksung Women's University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gingival index
- Secondary Outcome Measures
Name Time Method probing depth;clinical attachment level;plaque index;bleeding on probing;Gingival recession;Biomarkers in sulcular fluid;Oral Health Impact Profile -14