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

MedibioLAB0 sites100 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional Study

Sex

All

Sponsor

MedibioLAB

•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

•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
•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

Not specified