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

Tooth Discoloration Clinical Trial

Official title:

Does Use of a Whitening Dentifrice Improve the Efficiency of In-office Tooth Bleaching Procedures? A Double-blind Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163069
• Other study ID #: 20170318
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2017
• Last updated: October 7, 2017
• Start date: January 18, 2017
• Est. completion date: August 24, 2017

Study information

• Verified date: October 2017
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 24, 2017
• Est. primary completion date: July 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Discoloration

Intervention

Combination Product:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tooth colour	Colour parameters (CIE L*, a*, b*) will be measured with a spectrophotometer (Vita Easyshade Advance 4.0). The color alteration after each session will be given by the differences between the values obtained at the sessions and the baseline (?E).	4 weeks
Secondary	Change in tooth whiteness	The whiteness index will be registered at the sessions and the baseline.	4 weeks