None listed
Conditions
Sponsors
Chosun University Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women at least 19 years of age and less than 70 years of age 2) A score of 2 or more on the organoleptic test for halitosis 3) H2S 1.5 ng/10 mL or more or CH3SH 0.5 ng/10 mL or more 4) Bleeding on Probing (BOP) sites of 10% or more, and at least one tooth with a probing depth of more than 3 mm and less than 5 mm. 5) Those with bleeding on probing 6) Those with gingivitis or mild periodontitis symptoms 7) Those with 20 or more existing natural teeth * If some individuals with periodontal pocket probing depths between 5 and 6 mm or moderate periodontitis are included (as ethically acceptable), individuals taking medication or requiring prescription medication must be excluded.
Exclusion criteria
Exclusion criteria: 1) Scaling within 1 month of Visit 1 or periodontal treatment within 6 months of Visit 1 2) Subjects with significant pathologic findings in the soft tissues of the oral cavity 3) Have a history or condition of bleeding, or are taking antiplatelet or anticoagulant medication to prevent bleeding 4) The presence of 5 or more teeth in the oral cavity that require immediate treatment for dental caries 5) Patients with periodontitis requiring surgery or acute treatment 6) Patients with cancer within the past 5 years 7) Patients with concomitant dental disease requiring surgery, tooth extraction, etc. during the study period 8) Patients with uncontrolled hypertension (160/100 mmHg or greater, measured after 10 minutes of patient rest) 9) Patients with uncontrolled diabetes (fasting blood glucose greater than or equal to 180 mg/dL or new initiation of medication for diabetes within 3 months) 10) Subjects with AST (GOT) or ALT (GPT) blood levels greater than or equal to 3 times the upper limit of normal for their institution 11) Creatinine levels greater than or equal to 2 times the upper limit of normal for the respective institution 12) Subjects with clinically significant cardiovascular, immunologic, infectious, or tumor diseases 13) Mental illness such as schizophrenia, depression, drug addiction, alcoholism, etc. 14) Pregnant or planning to become pregnant within 6 months 15) Nursing mothers or women within 6 months of childbirth 16) Patients taking medication for prostate enlargement 17) Those who have taken medications that may affect periodontal status (Phenytoin, CCBs, Cyclosporine, Cumadin, NSAIDs, Aspirin, etc.) for more than 5 consecutive days within 1 month prior to Visit 1 18) Patients who have taken antibiotics, periodontal supportive therapy within 1 month prior to visit 1 19) Excessive alcohol consumption (> 20 g/day) 20) Smokers 21) Sensitive or allergic to any of the food ingredients in this human application study 22) Subjects who have taken dietary supplements related to halitosis or gum health within 1 month prior to Visit 1 23) Consumption of lactobacillus-containing foods consistently (more than 4 times per week) within 2 weeks prior to Visit 1 24) Participation in other clinical trials within 1 month prior to Visit 1 25) deemed unsuitable for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gingival index | — |
Secondary
| Measure | Time frame |
|---|---|
| Pocket depth (Periodontal proving depth);Clinical attachment level;Plaque index;Bleeding on proving;Gingival recession;inflammatory protein;volatile sulfur compounds;organoleptic test;bad breath improvement;Before intake (Visit 1, 2: Week -4, 0) and after intake (Visit 3, 4: Week 4, 8);Before intake (Visit 1, 2: Week -4, 0) and after intake (Visit 3, 4: Week 4, 8) | — |
Countries
Korea, Republic of
Contacts
Public ContactHee-Won Jeon
Chosun University Dental Hospital
Outcome results
None listed