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Clinical evaluation of tooth-whitening efficacy of Saky whitening strips

Clinical evaluation of tooth-whitening efficacy of Saky whitening strips

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073971
Enrollment
Unknown
Registered
2023-07-26
Start date
2023-08-20
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Extrinsic tooth stain

Interventions

Experiment Group:Use Saky tooth whitestrips Tape and designated toothpaste and toothbrush
Control group:Use a simulated tooth wthitestrips (a simulated product that looks similar to the Saky white strips, with the active ingredients of whitening removed) and a designated toothpaste toothb

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18-55 years old, no limitation in gender. (2) Good general health, no serious systemic diseases (3) The 8 incisors were naturally arranged neatly, and there was no large area of filling or crown restoration; (4) The teeth had extrinsic stain, and the color value of the Vita shadeguide of the anterior teeth is >1M1.5 (5) Voluntarily participate in trials, comply with clinical trial requirements, and follow up on time.

Exclusion criteria

Exclusion criteria: 1) The tested teeth had untreated caries, mucosal disease, dentin sensitivity, pericoronitis, periodontitis and other diseases; (2) The tested tooth has crown restoration, wearing denture or orthodontic device, etc (3) The tested teeth had extensive restoration, suspected pulpitis, caries, enamel cracks and so on (4) Severe or atypical intrisic staining of the tested teeth (5) Allergic persons (mainly refers to those who are allergic to the product ingredients such as hydrogen peroxide) (6) women during pregnancy and breastfeeding (7) Use other teeth whitening products within the past 3 months; (8) Taking anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory agents, analgesics; (9) Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system and diseases such as neuropsychiatric system; (10) Patients with oral soft and hard tissue tumors; (11) Subjects also participated in other clinical trials and did not meet the clinical endpoint (12) Subjects deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
shade value of Vita Easyshade Computer colorimeter ;

Secondary

MeasureTime frame
shade value of Vita guide;

Countries

CHINA

Contacts

Public ContactYIN WEI

West China Hospital of Stomatology, Sichuan University

yinwei1980@scu.edu.cn+86 138 8220 8058

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 16, 2026