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Clinical Evaluation of the Whitening Effect of BIEMIN Toothpaste

Clinical Evaluation of the Whitening Effect of BIEMIN Toothpaste

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096002
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tooth stains

Interventions

Control group:Control toothpaste for removing active ingredients
Test group:BIEMIN toothpaste

Sponsors

Hospital of Stomatology, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Healthy adults (18 to 65 years old); 2. Willing to whiten their teeth; 3. Have 12 natural anterior teeth with extrinsic stains and no fillings or crown restorations; 4. Extrinsic stains refer to color changes and discoloration caused by lifestyle factors such as drinking tea, smoking, drinking red wine, and other dietary habits.) d) Have at least one tooth with dentin hypersensitivity, sensitive to tactile stimuli of 10g to 50g, and/or sensitive to cold air stimuli; 5. Signed informed consent and able to complete the clinical trial as required; 6. Not simultaneously participating in any other similar clinical trials; 7. Agree to postpone any non-emergency dental examinations, including professional cleaning, until the end of the trial; 8. Agree not to use any non-study toothpaste or mouthwash during the trial period; 9. Have not used the following medications in the month prior to the study: anticonvulsants, antihistamines, antidepressants, sedatives, and tranquilizers.

Exclusion criteria

Exclusion criteria: 1. Simultaneously participating in other clinical studies; 2. Women who are pregnant or breastfeeding; 3. History of allergy to the product or its components; 4. Suffering from AIDS, insulin-dependent diabetes, undergoing anticancer chemotherapy within the last 6 months, immunodeficiency, autoimmune diseases, or other serious illnesses; 5. Suffering from uncontrolled gingivitis, periodontal disease, or oral ulcers, or wearing partial or full dentures; 6. Smoking or using tobacco products; 7. Any condition or disease that, in the opinion of the investigator, may affect the subject's safe completion of the trial.

Design outcomes

Primary

MeasureTime frame
Lobene stain index, LSI;

Secondary

MeasureTime frame
Sensitivity;

Countries

China

Contacts

Public ContactDu Mi

Hospital of Stomatology, Shandong University

mi.du@sdu.edu.cn+86 531 88382999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026