Diabetes mellitus accompanied by symptoms of oral frailty
Conditions
Interventions
Placebo group:Diabetic and orally frail population receiving placebo
Intervention Group 1:Healthy adults using postbiotic toothpaste
Intervention Group 2:Diabetic and orally frail population using postbiotic toothpaste
Sponsors
Hainan General Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Male or female diabetic volunteers, aged 20 to 80 years; diagnosed with oral frailty according to the Oral Frailty Index-8 criteria. 2.During the trial period, participants agree not to take any oral probiotics, postbiotics, or oral products or supplements with similar functional claims that may disrupt the oral microbiota or affect the evaluation of the trial outcomes. 3.Willing to not participate in any other interventional clinical studies during the trial period. 4.Able to fully understand the nature, purpose, potential benefits, as well as the possible risks and side effects of this study. 5.Willing to comply with all study requirements and procedures. 6.Sign the informed consent form. Male or female diabetic volunteers, aged 20 to 80 years; diagnosed with oral frailty according to the Oral Frailty Index-8 criteria.
Exclusion criteria
Exclusion criteria: 1.Individuals with severe oral diseases, such as severe periodontitis, acute pulpitis, acute periodontal abscess, severe oral mucosal ulceration, trauma, or other acute conditions; 2.Individuals currently suffering from severe systemic diseases or conditions that may affect safety, such as major diseases involving the heart, liver, kidney, hematologic system, immune system, or malignancies (e.g., severe cardiac insufficiency, liver cirrhosis, renal failure, autoimmune diseases, etc.); 3.Individuals with severe allergic constitution or a history of severe drug allergy (especially those allergic to oral care products or cosmetic ingredients); 4.Individuals with any of the following medical histories or clinical findings of diseases that may affect the evaluation of trial outcomes: severe gastrointestinal disorders, uncontrolled diseases of the liver, kidney, endocrine, hematologic, respiratory, or cardiovascular systems (patients with grade 3 or higher hypertension: blood pressure SBP >= 180 mmHg and/or DBP >= 110 mmHg); 5.Individuals who have used antibiotics, glucocorticoids, or immunosuppressants systemically within 1 month prior to the intervention; 6.Individuals who have used toothpaste, mouthwash, lozenges, sprays, or other oral care products with probiotic/postbiotic claims within 1 month prior to the intervention and are unwilling to discontinue use during the washout period as required by the study, which may disrupt the oral microbiota or affect the evaluation of trial outcomes; 7.Individuals who have used prescription mouthwash or topical oral medications with significant antibacterial or anti-inflammatory effects within 1 month prior to the intervention; 8.Male or female volunteers planning to conceive, pregnant or lactating women, or those planning to become pregnant during the trial period; 9.Individuals who are allergic to postbiotics or any components of the intervention materials used in this study; 10.Individuals with a history of alcohol abuse; 11.Individuals who chew betel nut more than 2 days per week; 12.Individuals whom the Principal Investigator (PI) considers unable to fully comply with the trial arrangements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oral microbiome; | — |
Countries
China
Contacts
Public ContactFang Tuanyu
Hainan General Hospital
Outcome results
None listed