None listed
Conditions
Interventions
Dietary Supplement : 1) Test Product
? Main Ingredient: Sarcodon aspratus extract
? Appearance and Form: Light brown, slightly turbid liquid for oral ingestion
? Daily Intake: 3.75 mg of Sarcodon aspr
Sponsors
Seoul National University Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 19 to 75 years at the time of screening. 2. Subjects with =10% BOP (Bleeding on Probing) sites and at least one tooth with PD (Probing Depth) >3 mm and =5 mm (Note: Subjects with PD 5–6 mm or mild-to-moderate periodontitis may be included; however, those requiring medication or prescription treatment must be excluded.) 3. Subjects with at least 20 existing natural teeth (excluding implants and wisdom teeth). 4. Subjects who voluntarily provide written informed consent for participation in the clinical study.
Exclusion criteria
Exclusion criteria: 1. Subjects with periodontitis requiring surgery or acute treatment. 2. Subjects with severe pathological findings of soft tissue within the oral cavity. 3. Subjects who require immediate treatment for dental caries in =5 teeth. 4. Subjects who have received scaling within 3 months prior to screening, or oral prophylaxis, subgingival curettage, or other periodontal treatment within 6 months prior to screening. 5. Subjects who are expected to require orthodontic treatment, dental surgery, or extraction during the study period. 6) Subjects who have taken antibiotics or medications used for the treatment of periodontal disease(e.g., Avocado/Soya Unsaponifiable, Hyaluronic acid, Potassium nitrate, Zea mays L. Unsaponifiable, Yee-Gatran F, deoxycycline, etc.)or oral/injectable corticosteroids (e.g., betamethasone, deflazacort, dexamethasone, prednisone, hydrocortisone, methylprednisolone, triamcinolone) within 1 month prior to the screening visit. 7. Subjects who have taken, for =5 consecutive days within 1 month, medications that may affect periodontal status, including: Anticonvulsants (e.g., phenytoin, sodium valproate, phenobarbital, vigabatrin, primidone, ethosuximide, etc.), Calcium channel blockers (e.g., nifedipine, amlodipine, verapamil, diltiazem, felodipine, etc.), NSAIDs (e.g., aspirin, ibuprofen, naproxen, etc.) 8. Subjects who have consumed health functional foods related to gum health within 1 month prior to screening. 9. Subjects with a history of bleeding disorders or who have taken antiplatelet agents or anticoagulants (e.g., warfarin) within 1 month prior to screening. 10. Subjects who have taken immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus) within 1 month prior to screening. 11. Subjects diagnosed with, or with a history of, malignancy within the past 5 years. 12. Subjects with uncontrolled hypertension (=160/100 mmHg after 10 minutes of rest). 13. Subjects with uncontrolled diabetes (fasting glucose =180 mg/dL, or those who initiated diabetes medication within the past 3 months). 14. Subjects with current or past clinically significant diseases of the hepatobiliary system, kidneys, central or peripheral nervous system, respiratory system (including asthma), endocrine system (including uncontrolled thyroid disease or hyperlipidemia), hematologic/oncologic disorders, genitourinary system, psychiatric disorders, musculoskeletal system, or immune system (including rheumatoid arthritis, SLE, immunodeficiency disorders), which in the investigator’s judgment make the subject unsuitable for this study. 15. Subjects with psychiatric illnesses such as schizophrenia, depression, or drug addiction. 16. Subjects with excessive alcohol consumption: Men =21 drinks/week; women =14 drinks/week - 1 standard drink = 10 g alcohol = 1 shot of soju (50 mL) = 1 glass of beer (200 mL) 17. Subjects who smoke =7 cigarettes per day (for e-cigarettes: 10 puffs = 1 cigarette). 18. Subjects with gastrointestinal diseases affecting absorption of the investigational product (e.g., Crohn’s disease), or a history of gastrointestinal surgery (excluding simple appendectomy or hernia repair). 19. Subjects with a history of hypersensitivity to medications or investigational food products, or clinically significant allergic reactions. 20. Subjects with abnormal clinical laboratory test results: (1) ALT or AST > 3× upper limit of normal (2) Serum creatinine > 2.0 mg/dL 21. Subjects who have participated in another clinical trial within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gingival index | — |
Secondary
| Measure | Time frame |
|---|---|
| Probing Depth;Clinical Attachment Level;Plaque Index;Bleeding on Probing;Gingival Recession;Inflammatory markers(TNF-a, IL-1ß, IL-6, hs-CRP);Periodontal tissue and structural markers(MMP-8, MMP-9, RANKL, OPG, CTX);Oral Health Impact Profile(OHIP-14);Antimicrobial markers(Red complex, A.actinomycetemcomitans);100 mm VAS;Adverse Event;Vital sign;Laboratory Tests | — |
Countries
Korea, Republic of
Contacts
Public ContactGyeongseok Jung
Seoul National University Dental Hospital
Outcome results
None listed