Clinical trial NCT03163069: The Effect of Whitening Toothpaste on Tooth Color Associated With Bleaching Process
Official title: Does Use of a Whitening Dentifrice Improve the Efficiency of In-office Tooth Bleaching Procedures? A Double-blind Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Discoloration
Keywords: tooth bleaching
dentifrice
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: factorial assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in tooth colour
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in tooth whiteness
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University
state: Fujian
Study officials:
affiliation: Fujian Medical University, China
name: Hao Yu
role: PRINCIPAL_INVESTIGATOR
References: