a clinical trial to effect of oral lacto-bacteria for the improvement of periodontal disease

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006582

Enrollment

Registered

2021-09-15

Start date

2021-09-30

Completion date

Unknown

Last updated

2021-10-05

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 : Compare test group and control group How to use: Once a day, take 1 tablet. Dissolve and swallow after 30 minutes of brushing. before going to bed Test group: Lactoglow (oral pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 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)

Exclusion criteria

Exclusion criteria: ? 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

Design outcomes

Primary

Measure	Time frame
Gingival index (GI: Gingival index) change	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public Contactjihye choi

Yonsei University Health System, Dental Hospital

pennsv@gmail.com+82-2-2228-2951

Outcome results