None listed
Conditions
Interventions
Dietary Supplement : Participants in the experimental group will be assigned GDM-001, while those in the control group will receive a GDM-001 placebo. Both groups will take one tablet daily for 12 wee
Sponsors
Dankook University Dental Hostipal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - A person aged 19 or more to less than 70 at the time of screening - Participants with at least one tooth showing over 10% of sites with BOP (Bleeding on Probing) and a PD (Probing Depth) of more than 3 mm but less than 5 mm. ----- These participants have been diagnosed by a dental professional with mild gingivitis but do not experience significant discomfort in daily life. - Individuals with a minimum of 20 natural teeth remaining (excluding implants and third molars) - Individuals who voluntarily provided written informed consent for participation in the human application study
Exclusion criteria
Exclusion criteria: 1) Individuals currently undergoing treatment for severe conditions affecting the cardiovascular, immune, gastrointestinal/hepatic and biliary, renal and urogenital, nervous, musculoskeletal systems, or infectious diseases 2) Individuals with mental disorders, including schizophrenia, depression, or substance abuse 3) Individuals with a history of bleeding disorders or bleeding-related diseases 4) Individuals diagnosed with cancer within 5 years prior to Visit 1 5) Individuals with the following oral conditions: ? Extensive untreated or long-standing dental caries ? Teeth requiring immediate treatment, such as periodontal abscesses or teeth needing extraction ? Currently using orthodontic appliances or removable partial dentures ? Significant pathological findings in oral soft tissues ? Any concurrent dental disease requiring surgery, extraction, or other treatments during the study period ? Individuals who received scaling within 1 month (30 days) or periodontal treatment within 6 months prior to Visit 1 6) Individuals who have taken any of the following medications or supplements: ? Antibiotics or adjunctive periodontal treatment agents within 1 month (30 days) prior to Visit 1 ? Health supplements related to gum health, such as propolis, calcium, and vitamins C, D, or E, within 1 month (30 days) prior to Visit 1 ? Medications that may affect periodontal condition (e.g., Phenytoin, CCBs, Cyclosporine, anticoagulants like Coumadin, NSAIDs, antiplatelets like Aspirin) taken consecutively for more than 5 days within 1 month (30 days) prior to Visit 1 7) Individuals with a BMI below 18.5 kg/m² or above 35.0 kg/m² at Visit 1 8) Smokers (those who have quit for at least 6 months prior to Visit 1 may participate) 9) Individuals with a history of alcohol abuse or chronic alcohol consumption Defined as an average daily intake of more than 40 g of alcohol (280 g/week) for men and more than 20 g (140 g/week) for women 10) Individuals with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73m² 11) Individuals with AST (GOT) or ALT (GPT) levels exceeding three times the upper limit of normal at the study site 12) Individuals with uncontrolled hypertension (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, measured after 10 minutes of rest for study eligibility) 13) Individuals with uncontrolled diabetes (HbA1c > 7.0% or who started diabetic medication within the last 3 months) 14) Women who have given birth within the last 6 months prior to Visit 1 15) Pregnant or breastfeeding women, or individuals planning to become pregnant during the study period 16) Individuals who participated in another interventional clinical trial (including human application studies) within 1 month (30 days) prior to Visit 1, or who plan to participate in another interventional clinical trial (including human application studies) during the current study period 17) ndividuals with allergies or sensitivities to any ingredients in the test food used in this study 18) Individuals deemed unsuitable by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gingival Index;Pocket Depth;Bleeding On probing;Gingival Recessio;Clinical Attachment Level;Plaque Index;TNF-a, IL-6, MMP-9; OHIP-14(Oral Health Impact Profile-14);Porphyromonas gingivalis, Prevotella intermedia | — |
Secondary
| Measure | Time frame |
|---|---|
| lifestyle questionnaire;GPAQ(Global Physical Activity Questionnaire);Compliance | — |
Countries
Korea, Republic of
Contacts
Public ContactLEE Jae Young
Dankook University
Outcome results
None listed