A 12 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Probiotics on Gingival Health
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0007555
- Lead Sponsor
- Chosun University Dental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Those who have BOP (bleeding on probing) site of 10% or more in all teeth, and have one or more teeth with PD (Probing Depth) of 3 mm or more and 5 mm or less
2) Those with one or more teeth with a GI score of 2 or higher
3) Those who have at least 20 existing natural teeth (excluding implants)
4) A person who has agreed to participate in this clinical trial before the start of the clinical trial and has written a written consent
1) Those who are currently being treated for severe cardiovascular, immune, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, infectious disease, etc.
2) People with mental disorders such as schizophrenia, depression, and drug addiction
3) Those who developed cancer within the past 5 years
4) A person with a history of bleeding or a disease, or a person taking antiplatelet drugs or anticoagulants for prevention
5) Those who show serious pathological findings in the soft tissues of the oral cavity
6) Those who need treatment such as surgery or tooth extraction due to accompanying orthodontic or dental disease during the clinical trial period
7) Based on Visit 1, women within 6 months of giving birth
8) Smokers
9) Those who received scaling treatment within 3 months of visit 1 or periodontal treatment within 6 months
10) Those who have taken drugs that can affect periodontal condition (Phenytoin, CCBs, Cyclosporine, Coumadin, NSAIDs, Aspirin, etc.) for 5 or more consecutive days within 1 month based on Visit 1
11) Those who have taken antibiotics or supportive drugs for periodontal disease within 1 month based on visit 1
12) Those who have consumed health functional food related to gingival health within 1 month based on visit 1
13) Those who have consumed probiotics, prebiotics, or lactobacillus products continuously (4 or more times a week) within 2 weeks of visit 1
14) Patients with uncontrolled hypertension (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, measurement standard after subject resting for 10 minutes)
15) Patients with uncontrolled diabetes mellitus (fasting blood sugar of 180 mg/dL or higher, or starting medication for diabetes within 3 months)
16) Those whose creatinine is more than twice the normal upper limit of the implementing institution
17) Those whose AST(GOT) or ALT(GPT) is more than 3 times the upper limit of normal
18) Those who are pregnant, lactating, or planning to become pregnant during this human application test period
19) Those who have participated in other interventional clinical trials (including human trials) within 3 months of Visit 1, or plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
20) Those who are sensitive to or allergic to the food ingredients for this clinical trial
21) Those who are judged inappropriate by the investigator for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gingival index
- Secondary Outcome Measures
Name Time Method Pocket depth (Periodontal proving depth);Clinical attachment level;Plaque index;Bleeding on proving;Gingival recession;Biomarkers in gingival crevicular fluid;Oral bacteria;OHIP-14 (Oral Health Impact Profile-14)