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Randomized, Double-Blind, Parallel-Controlled, Single-Center Clinical Efficacy Trial on the Efficacy and Safety of DARLIE All Shiny White Magnificent Dual Chamber Toothpaste

Randomized, Double-Blind, Parallel-Controlled, Single-Center Clinical Efficacy Trial on the Efficacy and Safety of DARLIE All Shiny White Magnificent Dual Chamber Toothpaste

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123380
Enrollment
Unknown
Registered
2026-04-26
Start date
2025-11-12
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Teeth whitening

Interventions

Experimental group:oothpaste of the test group was used once in the morning and once in the evening, and the teeth were brushed for three minutes each time, and the toothpaste was squeezed into the wh
Placebo control group:The placebo control toothpaste was used, and the teeth were brushed for three minutes in the morning and evening, and the toothpaste was squeezed into the whole toothbrush head

Sponsors

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years old, regardless of gender. 2. Willing to whiten teeth. 3. Having 12 natural anterior teeth in the mouth, without obvious exogenous stains (stains can be removed by teeth cleaning), and without fillings or crown restorations. 4. Voluntarily sign the informed consent form. 5. Not participating in other clinical trials during the trial period. 6. Agree to postpone any non-emergency oral examinations and teeth cleaning until the end of the trial. 7. Agree not to use any non-trial toothpaste or mouthwash during the trial period. 8. Immediately after supragingival scaling, use the VITA Bleachhedguide 3D-MASTER29 shade guide for color comparison, and the observed average value of the teeth is above 18.

Exclusion criteria

Exclusion criteria: 1. Subjects with severe oral diseases or chronic diseases; any severe periodontal disease and dental calculus, especially at the anterior gingival margin; and untreated dentin hypersensitivity. 2. History of allergy to the test product. 3. Females who are pregnant or lactating. 4. Currently participating in other clinical trials. 5. Used non-test toothpaste or mouthwash in addition to the distributed products. 6. Malocclusion or wearing fixed orthodontic appliances, with fixed or removable dentures on the anterior teeth. 7. Intrinsic staining such as tetracycline-stained teeth and fluorosis-stained teeth. 8. Any diseases or conditions that the trial investigator deems may affect the examination procedures and the subject's safe completion of the trial. 9. Received non-urgent oral treatment (excluding teeth cleaning) before the end of the trial. 10. Smokers.

Design outcomes

Primary

MeasureTime frame
Visual evaluation of color swatches;

Countries

China

Contacts

Public ContactZhao Junhai

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

1048150480@qq.com+86 135 7103 3120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026