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Clinical Study on the Effect of the Bixdo Star-sparkling Brightening Toothpaste on Removing Exogenous Pigment from Teeth

Clinical Study on the Effect of the Bixdo Star-sparkling Brightening Toothpaste on Removing Exogenous Pigment from Teeth

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076799
Enrollment
Unknown
Registered
2023-10-18
Start date
2023-10-19
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Exogenous Pigment

Interventions

A:Fluoride non-whitening toothpaste
B:Test product fluoride whitening toothpaste

Sponsors

Hospital of Stomatology, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Healthy adults (18~65 years old), gender is not limited; 2) Willing to whiten teeth; 3) 12 natural front teeth in the mouth, and these 12 natural front teeth do not have fillings or crown restorations; 4) Certain exogenous coloration, and the average Lobene index is greater than 1.5; 5) Signed the informed consent form, voluntarily participated in the trial, was willing to comply with the clinical trial requirements, and followed up on time; 6) Do not participate in other clinical trials during the trial; 7) Agree to postpone any non-emergency oral examination, including dental cleaning, until the end of the trial; 8) Agree not to use any non-test toothpaste, mouthwash, electric toothbrush, toothbrush, toothbrush, etc. during the test.

Exclusion criteria

Exclusion criteria: 1) Serious systemic diseases; 2) Any serious periodontal disease and calculus, especially at the anterior gum margin; 3) Unhealed dentin sensitivity; 4) A history of allergy to the test product; 5) Pregnant or breastfeeding women; 6) Currently participating in other clinical trials or have participated in other clinical trials in the past 3 months; 7) Occlusion that occludes the front teeth or wears fixed aligners, and the front teeth have fixed or removable dentures; 8) Endogenous coloring of tetracycline teeth, fluorosis teeth and so on; 9) Those who have undergone dental cleaning treatment within the past 3 months; 10) Have used teeth whitening products in the past 3 months; 11) The presence of any diseases and conditions that the trial investigator believes may affect the procedure of the examination and the safe completion of the test by the subject.

Design outcomes

Primary

MeasureTime frame
Lobene index;

Secondary

MeasureTime frame
Vita L,a value;Tooth color grade;user satisfaction;

Countries

China

Contacts

Public ContactHuancai Lin

Hospital of Stomatology, Guanghua School of Stomatology, Sun Yat-sen University

linhc@mail.sysu.edu.cn+86 139 2415 2290

Outcome results

None listed

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