None listed
Conditions
Interventions
Dietary Supplement : Participants will consume the assigned investigational product (IP) once daily according to their randomized group allocation. One tablet will be taken before bedtime, to be disso
Sponsors
Mediogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 19 to 70 years 2) Individuals with more than 20 natural teeth 3) Individuals whose oral gas concentration related to halitosis at both Visit 1 and Visit 2 is H2S 1.5 ng/10 mL or more or CH3SH 0.5 ng/10 mL or more 4) Individuals in whom at least 3 of the 6 specific pathogenic oral bacteria (P. gingivalis, T. denticola, T. forsythia, P. intermedia, C. rectus, F. nucleatum) were detected through oral microbiological assessment using a mouth rinse at both visit 1 and visit 2. 5) Individuals who agree to participate in this clinical trial prior to its initiation and sign the written informed consent form (ICF)
Exclusion criteria
Exclusion criteria: 1) Individuals currently undergoing treatment for severe diseases of the cardiovascular, immune, respiratory, gastrointestinal/biliary, nervous, or musculoskeletal systems, as well as for infectious diseases or malignant tumors 2) Individuals currently undergoing treatment for, or with a history of, systemic diseases that may cause halitosis (e.g., liver disease, kidney disease, Sjögren’s syndrome, rheumatic disease, sinusitis, rhinitis, chronic gastritis, psychiatric disorders, endocrine disorders, etc.); however, participation may be allowed at the investigator’s discretion based on the participant’s condition 3) Individuals with gastrointestinal disorders (e.g., gastritis, gastric ulcer) that interfere with the consumption of the investigational food 4) Individuals with severe dental diseases (e.g., periodontitis, dental caries, xerostomia); participants with enamel caries may be included, but those with at least one dentin caries will be excluded 5) Individuals using orthodontic appliances or removable dentures 6) Smokers 7) Individuals who have undergone scaling or other dental treatments (e.g., periodontal treatment) within 1 month (30 days) prior to Visit 1 8) Individuals who have used adjunctive treatments for periodontal disease within 3 months (90 days) prior to Visit 1 9) Individuals who have taken any of the following medications (or foods) within 2 weeks prior to Visit 1: ? Medications that reduce salivary secretion (e.g., medications for benign prostatic hyperplasia, antihistamines, antidepressants, antipsychotics) ? Medications that may affect bacterial composition (e.g., antibiotics) ? Digestive aids (eubiotics) ? Probiotics, prebiotics, or lactic acid bacteria products consumed regularly (=4 times per week) ? Medications or health functional foods for alleviating halitosis 10) Individuals who have used preparations containing oral hygiene ingredients within 1 week prior to Visit 1 11) Individuals with uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg, measured after 10 minutes of rest) 12) Individuals with diabetes who are taking oral hypoglycemic agents or insulin 13) Individuals with serum AST (GOT) or ALT (GPT) levels =3 times the upper limit of the normal range of the testing institution 14) Individuals with an eGFR of less than 60 mL/min/1.73 m² 15) Individuals who chronically consume alcohol* *Equivalent to an average daily alcohol intake of =40 g (280 g/week) for men or =20 g (140 g/week) for women 16) Individuals who have participated in another interventional clinical trial (including human intervention trials) within 3 months (90 days) prior to Visit 1, or who plan to participate in another interventional clinical trial (including human intervention trials) during this trial 17) Pregnant or lactating women, or women planning to become pregnant during the trial period 18) Individuals with sensitivity or allergy to any component of the investigational food (test or control product) 19) Individuals deemed unsuitable for participation for any other reason by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral gas concentration related to halitosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral microorganisms;Tongue Plaque Index (TPI);Halitosis Associated Life-quality Test (HALT);Clinical pathology tests;Vital signs;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Won Kim
Apple Tree Medical Foundation
Outcome results
None listed