a clinical trial to effect of oral lacto-bacteria for the improvement of periodontal disease
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006582
- Lead Sponsor
- DENTIS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 63
? 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
? smoker
? 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gingival index (GI: Gingival index) change
- Secondary Outcome Measures
Name Time Method Plaque Index (PI);Halitosis;Probing Depth (PD);Gingival Recession (GR);Clinical Attachment Level (CAL);Bleeding On Probing (BOP);Changes in bacteria in the oral cavity