Skip to content

A 4 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Health Functional Food Clinical Trial for the Evaluation of the Efficacy and Safety of BenTooth on Gingival Health

A 4 week, Multi-center, Randomized, Double-Blind, Placebo-Controlled Health Functional Food Clinical Trial for the Evaluation of the Efficacy and Safety of BenTooth on Gingival Health

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008485
Enrollment
110
Registered
2023-06-01
Start date
2022-07-19
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

None listed

Interventions

Dietary Supplement : Eat the test food (BenTooth) once a day (dinner) and two tablets once a day with sufficient water one hour after eating (500 mg/day using a compound such as burdock root extract)

Sponsors

Ben’s Lab
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) An adult male and female over 20 years of age and under 80 years of age 2) A person who has at least one tooth with a BLEEDING ON PROBING (BOP) site of 10% or more and a PD (Probing Depth) of 3 mm or more and 5 mm or less in all teeth 3) A person who has one or more teeth with a GI score of 2 or more 4) Those who have at least 20 natural teeth (excluding implants) 5) A person who agrees to participate in this human body application test before the start of the human body application test and prepares a written consent form

Exclusion criteria

Exclusion criteria: 1) A person currently being treated for severe cardiovascular, immune, gastrointestinal/hepatic and biliary systems, kidney and urology, nervous, musculoskeletal, infectious diseases, etc 2) Mentally ill patients such as schizophrenia, depression, and drug addiction 3) A person who has developed cancer within the past five years 4) A person who has a history of bleeding or disease, or is taking antiplatelet drugs or anticoagulants 5) A person who shows serious pathological findings in soft tissue in the oral cavity 6) A person who needs surgery, extraction, etc. treatment due to dental diseases accompanying the human body application test period 7) Women within 6 months of childbirth based on visit 1 8) A smoker 9) A person who has received scaling treatment within three months or periodontal treatment within six months of visiting 10) A person who has taken drugs (Phenytoin, CCBs, Cyclosporine, Coumadin, NSAIDs, Aspirin, etc.) that can affect periodontal conditions for at least 5 consecutive days within 1 month of visit 1 11) A person who has taken antibiotics or periodontal disease supplementary treatment within one month of visit 1 12) A person who has consumed health functional foods related to gum health within one month of visit 1 13) Patients with uncontrolled hypertension (measured by systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, test subjects after 10 minutes of stabilization) 14) Uncontrolled diabetics (e.g. fasting blood sugar >180 mg/dL or new medication initiated due to diabetes within 3 months) 15) Those whose creatine is more than twice the normal upper limit of the implementing agency 16) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the institution 17) A person who is pregnant, lactating, or plans to conceive during this human body application test 18) A person who has participated in another interventional clinical trial (including human application test) within three months of visit 1, or plans to participate in another interventional clinical trial (including human application test) after the start of this human application test 19) A person who is sensitive or allergic to food ingredients for this human body application test 20) A person who judges that the tester is inappropriate for other reasons

Design outcomes

Primary

MeasureTime frame
GI(Gingival Index)

Secondary

MeasureTime frame
PD(Probing Depth), BOP(Bleeding On Probing);CAL(Clinical Attachment Level), PI(Plaque Index), GR(Gingival Recession), Biomarkers of Gingival Crevicular Fluid(IL-1ß, IL-6, MMP-9, MMP-13), OHIP-14((Oral Health Impact Profile-14)

Countries

Korea, Republic of

Contacts

Public ContactKyung Seok Jeong

Seoul National University Dental Hospital

taekigogo@naver.com+82-2-2072-3543

Outcome results

None listed

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