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The effect of OralShark whitening toothpaste on removing exogenous pigment on tooth surface: A clinical trail

The effect of OralShark whitening toothpaste on removing exogenous pigment on tooth surface: A clinical trail

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067510
Enrollment
Unknown
Registered
2023-01-10
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

exogenous pigment on tooth surface

Interventions

Pilot group:OralShark Whitening Toothpaste
Control group:OralShark Whitening Toothpaste Simulant

Sponsors

Hospital of Stomatology, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Healthy adults (18 to 65 years old). b) Willing to whiten their teeth. c) have 12 natural front teeth in the mouth with exogenous discoloration and no fillings or crown restorations. d) signed an informed consent form. e) Not participating in other clinical trials during the trial. f) agreed to postpone non-emergency oral examinations, including dental cleanings, until the end of the trial. g) agreed not to use non-trial toothpaste and mouthwash during the trial.

Exclusion criteria

Exclusion criteria: a) Subjects with serious oral or chronic illness; any serious periodontal disease and calculus, especially at the anterior gingival margin; untreated dentin sensitivity. b) A history of allergy to the test product. c) Women who are pregnant or breastfeeding. d) Currently participating in other clinical trials. e) Use a non-trial toothpaste or mouthwash in addition to the dispensed product. f) Malocclusion or wearing fixed orthodontic appliances, with fixed or removable dentures in the anterior teeth. g) Endogenous staining such as tetracycline and fluorosis. h) Presence of any disease and condition that, in the opinion of the trial investigator, may interfere with the examination procedure and the safe completion of the trial by the subject. i) Received elective oral treatment (including scaling) before the end of the trial.

Design outcomes

Primary

MeasureTime frame
Lobene Pigmentation Index;

Secondary

MeasureTime frame
Bacterial plaque index;

Countries

China

Contacts

Public ContactDu mi

Hospital of Stomatology, Shandong University

mi.du@sdu.edu.cn15169184607

Outcome results

None listed

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