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A Clinical Trial Investigating the Efficacy of ShuKe SeXiu Whitening Toothpaste in Removing Extrinsic Dental Stains

A Clinical Trial Investigating the Efficacy of ShuKe SeXiu Whitening Toothpaste in Removing Extrinsic Dental Stains

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120655
Enrollment
Unknown
Registered
2026-03-18
Start date
2025-12-03
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

extrinsic tooth stains

Interventions

test group:Participants in the test group will use ShuKe SeXiu Whitening Toothpaste, brushing twice daily (morning and evening) under the supervision of study staff.
control group:Participants in the control group will use a control toothpaste free of whitening agents, brushing twice daily (morning and evening) under the supervision of study staff.

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. In good general health, with 12 natural anterior teeth present, and without extensive restorations such as large fillings or crowns in the oral cavity; 2. Aged 18 to 65 years; 3. Presence of extrinsic tooth staining, with a mean Lobene stain score of =1.5; 4. Willing to sign the informed consent form and able to complete the clinical trial as required; 5. Not currently participating in any other similar clinical studies. Agrees not to use any non-study toothpaste, mouthwash, whitening strips, whitening pens, or similar products during the trial period; 6. Agrees to postpone any non-emergency oral examinations or treatments (including dental cleaning/scaling) until the end of the trial.

Exclusion criteria

Exclusion criteria: 1. History of allergy to any ingredient in the test toothpaste; 2. Received tooth whitening treatment within 1 month prior to the start of the study; 3. Presence of moderate or severe periodontitis; calculus at the gingival margin of the anterior teeth; or unresolved dentin hypersensitivity; 4. Presence of more than two open carious lesions or any oral mucosal lesions; 5. Women who are pregnant or breastfeeding, or planning to become pregnant during the study period; 6. Participation in any other clinical study involving oral/dental products during the study period; 7. Presence of intrinsic tooth discoloration, such as dental fluorosis or tetracycline-stained teeth; 8. Presence of any other serious oral disease or systemic disease (such as hematologic disorders, liver disease, diabetes, etc.); 9. Inability to brush teeth twice daily, in the morning and evening; 10. Any disease or condition that, in the opinion of the investigators, may affect the examination procedures or the subject’s safe completion of the study.

Design outcomes

Primary

MeasureTime frame
Lobene index;

Countries

China

Contacts

Public ContactZhou Shuangying; An Na

Department of Periodontology, Peking University School and Hospital of Stomatology

shyingzhou@126.com+86 10 8219 5368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026