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

NCT ID: NCT03163069

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-18

Study Completion Date

2017-08-24

Brief Summary

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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

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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).

Conditions

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Tooth Discoloration

Keywords

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tooth bleaching dentifrice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

factorial assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Conventional Whitening dentifrice

in-office bleaching with the conventional whitening dentifrice

Group Type EXPERIMENTAL

in-office bleaching with the conventional whitening dentifrice

Intervention Type COMBINATION_PRODUCT

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). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the conventional whitening dentifrice.

Whitening dentifrice containing blue covarine

in-office bleaching with the whitening dentifrice containing blue covarine

Group Type EXPERIMENTAL

in-office bleaching with the whitening dentifrice containing blue covarine

Intervention Type COMBINATION_PRODUCT

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). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the whitening dentifrice containing blue covarine.

Regular dentifrice

in-office bleaching with the regular dentifrice

Group Type EXPERIMENTAL

in-office bleaching with the regular dentifrice

Intervention Type COMBINATION_PRODUCT

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). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the regular dentifrice.

Interventions

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in-office bleaching with the conventional whitening dentifrice

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). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the conventional whitening dentifrice.

Intervention Type COMBINATION_PRODUCT

in-office bleaching with the whitening dentifrice containing blue covarine

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). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the whitening dentifrice containing blue covarine.

Intervention Type COMBINATION_PRODUCT

in-office bleaching with the regular dentifrice

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). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the regular dentifrice.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hao Yu

Fujian Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hao Yu

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University, China

Locations

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Fujian Medical University

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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20170318

Identifier Type: -

Identifier Source: org_study_id