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A 8 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of MAEC on gingival health

A 8 week, multi-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of MAEC on gingival health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005569
Enrollment
100
Registered
2020-11-03
Start date
2019-09-23
Completion date
Unknown
Last updated
2020-12-02

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

Conditions

None listed

Interventions

Others(health functional food) : Once a day, 1 capsule at a time with sufficient water The intervention group consumed 194mg per day as a complex such as mangosteen extract. The control group had the

Sponsors

MedibioLAB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Men and women 20 years old or older and 75 years old or younger 2. Those with more than 10% BOP (Bleeding on Probing) site and one or more teeth with PD (Probing Depth) greater than 3mm and less than 5mm 3. Those with at least 18 existing natural teeth 4. Those who signed the Informed Consent Form before the start of this clinical trial

Exclusion criteria

Exclusion criteria: 1. Those who received scaling treatment and prophylactic periodontal treatment within 3 months of visit 1 2. Persons with a history of bleeding or disease, or taking antiplatelet drugs or anticoagulants to prevent them 3. Those with serious pathological findings on the soft tissues in the oral cavity (such as oral cancer patients) 4. Those who have 5 or more teeth to be treated for dental caries immediately 5. Patients with periodontitis requiring surgery or acute treatment 6. smoker 7. Those who took antibiotics within 2 weeks of visit 1 8. Patients with uncontrolled diabetes (fasting blood sugar greater than 180 mg/dl) 9. Those whose AST(GOT) or ALT(GPT) is more than 3 times the upper limit of the laboratory 10. Creatinine is more than twice the upper limit of the laboratory 11. Those with clinically significant cardiovascular, immune system, infectious, and neoplastic diseases 12. People with mental illness such as schizophrenia, depression, drug addiction, alcoholism, etc. 13. Those who are allergic to the main ingredients of the test food 14. Those who are pregnant or plan to become pregnant during this clinical trial, and those who are lactating 15. Those who have participated in other clinical trials within 1 month of visit 1 or plan to participate during the clinical trial period 16. A person who judges that the tester is inappropriate for this clinical trial

Design outcomes

Primary

MeasureTime frame
GI(Gingival Index)

Secondary

MeasureTime frame
PD(Probing Depth);CAL(Clinical Attachment Level);PI(Plaque Index);BOP(Bleeding on probing);GR(Gingival Recession);Biomarkers of saliva and gingival fissures(IL-1ß, IL-6, MMP-8, MMP-9);Oral Health Impact Profile-14(OHIP-14)

Countries

Korea, Republic of

Contacts

Public ContactJaekook Cha

Yonsei University Health System, Dental Hospital

Outcome results

None listed

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