The Effect of Whitening Toothpaste on Tooth Color Associated With Bleaching Process

Fujian Medical University

Status and phase: Completed; Phase 4

Conditions: Tooth Discoloration

Treatments: Combination Product: in-office bleaching with the conventional whitening dentifrice; Combination Product: in-office bleaching with the whitening dentifrice containing blue covarine; Combination Product: in-office bleaching with the regular dentifrice

Study type: Interventional

Funder types: Other

Identifiers

NCT03163069

20170318

Details and patient eligibility

About

This double-blind randomized controlled clinical trial aimed to investigate the effect of whitening dentifrices on the clinical efficiency of in-office tooth bleaching procedures.

Full description

Sixty-three eligible participants (29 males and 34 females, mean age 26.1 years) with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 3 groups (n = 21), according to the different dentifrices used in this clinical trial: Crest Total (regular dentifrice) for group C, Crest 3D Whitening (conventional whitening dentifrice) for group CW, and Close Up White Now (whitening dentifrice containing blue covarine) for group CU. All participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). The participants will be instructed to use only the provided dentifrices and toothbrushes to brush their teeth twice daily over a 4-week period. Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0) at baseline (T1), after the first bleaching session (T2), after the second bleaching session (T3), 1 week after the completion of in-office bleaching (T4), and 3 weeks after the completion of in-office bleaching (T5). The colour differences (ΔE) and whiteness index (W) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).

Enrollment: 63 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients between 18 and 60 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score A3 or darker, as measured with the Vita Classical guide (Vita Zahnfabrik, Bad Sa ̈ ckingen, Germany) ordered by brightness

Exclusion criteria

• patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant women, people with known allergy to the product ingredients, smokers, and alcohol abusers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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63 participants in 3 patient groups

Conventional Whitening dentifrice

Experimental group

Description:

in-office bleaching with the conventional whitening dentifrice

Treatment:

Combination Product: in-office bleaching with the conventional whitening dentifrice

Whitening dentifrice containing blue covarine

Experimental group

Description:

in-office bleaching with the whitening dentifrice containing blue covarine

Treatment:

Combination Product: in-office bleaching with the whitening dentifrice containing blue covarine

Regular dentifrice

Experimental group

Description:

in-office bleaching with the regular dentifrice

Treatment:

Combination Product: in-office bleaching with the regular dentifrice