A 12 Week, Randomized, Double-Blind, Placebo-controlled, Single-Center, Clinical trial for the evaluation the efficacy of PROBIOTICs for improving Periodontal disease and changes in the oral microflora in Patients with Gingivitis and Mild Periodontitis.

DENTIS0 个研究点目标入组 63 人开始时间: 待定最近更新: 2021年10月5日

试验速览

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•? Male and female subjects between the ages of 20 and 75
•? Those diagnosed with gingivitis and mild periodontitis
•? Subjects with at least 20 natural teeth (excluding third molars and implants)
•? Those who voluntarily signed in writing to this Informed Consent Form(ICF)

•? Patients with moderate and severe periodontitis
•? Those who received scaling and preventive periodontal treatment before 3 months from the date of written consent
•? Persons wearing orthodontic appliances
•? Those who need pathological findings and other treatment for soft tissues in the oral cavity
•? Those who need to be treated for dental caries immediately in the oral cavity
•? Those with chronic diseases such as uncontrolled diabetes, liver disease, heart disease, kidney disease, hemorrhagic history or disease
•? Those who require treatment for clinically significant immune, infection, tumor, or mental illness
•? Those taking drugs that can affect periodontal disease (nifedipine, phenytoin, cyclosporine)
•? Persons taking antiplatelet drugs or anticoagulants
•? Those who have taken antibiotics within the last 4 weeks, are taking antibiotics, or plan to take antibiotics in the future
•? Persons who have received other investigational drugs or quasi-drugs within 30 days before participating in clinical trials
•? Pregnant or lactating women, women of childbearing age who are not using acceptable contraceptive methods
•? In cases other than the above, if the investigator in charge determine that subject is not suitable as a subject for this study

发起方

DENTIS