None listed
Conditions
Interventions
Dietary Supplement : Subjects will take the assigned IP(investigational product) once daily according to the randomly assigned group. They will consume one tablet before bedtime by dissolving or chewi
Sponsors
Mediogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those aged 19 to 70 years old 2) Those with more than 20 teeth 3) Those whose oral gas concentration due to bad breath at Visit 1 and Visit 2 was H2S 1.5 ng/10 mL or more or CH3SH 0.5 ng/10 mL or more 4) In the measurement of oral microorganisms on visit 1, at least 3 out of 6 specific harmful bacteria (P.gingivalis, T.denticola, T.forsythia, P.intermedia, C.rectus, F.nucleatum) were detected exceeding the baseline value. In the measurement of oral microorganisms on visit 1, at least 3 out of 6 specific harmful bacteria (P. gingivalis, T. denticola, T. forsythia, P. intermedia, C. rectus, F.nucleatum) were detected exceeding the baseline value. 5) A person who agrees to participate in this human application test and fills out a written consent form (Informed Consent Form) before the human application test begins
Exclusion criteria
Exclusion criteria: 1) Persons currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/biliary, neurological, musculoskeletal systems, infectious diseases, or malignant tumors. 2) Persons currently undergoing treatment or with a history of systemic diseases that may cause bad breath (liver disease, kidney disease, Sjogren's syndrome, rheumatoid diseases, sinusitis, rhinitis, chronic gastritis, psychiatric disorders, endocrine diseases, etc.). (However, participation is allowed based on the examiner's judgment considering the condition of the human application test subject.) 3) Persons with severe dental diseases (periodontitis, dental caries, xerostomia, etc.) at Visit 1 and Visit 2. (Participation is allowed for those with enamel caries, but not for those with one or more dentin caries.) 4) Persons using orthodontic devices or removable dentures at Visit 1 and Visit 2. 5) Smokers at Visit 1 and Visit 2. 6) Persons who have taken the following medications within 2 weeks of Visit 1 and Visit 2: ? Medications that reduce saliva secretion (e.g., treatments for benign prostatic hyperplasia) ? Medications that can affect bacterial composition (e.g., antibiotics) ? Digestive aids ? Probiotics, prebiotics, or products containing lactic acid bacteria taken regularly (four or more times a week) 7) Persons undergoing dental treatment or taking medications or health supplements to alleviate bad breath at Visit 1 and Visit 2. 8) Diabetic patients taking oral hypoglycemic agents or insulin. 9) Persons who have participated in other interventional clinical trials (including human application tests) within 1 month prior to Visit 1, or who plan to participate in other interventional clinical trials (including human application tests) after the start of this human application test. 10) Pregnant or breastfeeding women, or those planning to become pregnant during the period of this human application test. 11) Persons who are sensitive or allergic to the ingredients of the test foods (test foods and control foods) used in this human application test. 12) Persons deemed unsuitable by the examiner for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral gas concentration due to bad breath | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral microorganisms;TPI (Tongue plaque index) | — |
Countries
Korea, Republic of
Contacts
Public ContactEun-Mi Choi
Apple Tree Medical Foundation
Outcome results
None listed