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

NCT03163069 | Completed Phase 4 DMC

• 1 other identifier: 20170318
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Discoloration

Keywords

tooth bleaching; dentifrice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in tooth whiteness

  4 weeks

Study Arms (3)

Conventional Whitening dentifrice

EXPERIMENTAL

in-office bleaching with the conventional whitening dentifrice

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

Whitening dentifrice containing blue covarine

EXPERIMENTAL

in-office bleaching with the whitening dentifrice containing blue covarine

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

Regular dentifrice

EXPERIMENTAL

in-office bleaching with the regular dentifrice

Combination Product: in-office bleaching with the regular dentifrice

Interventions

in-office bleaching with the conventional whitening dentifrice 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.

Conventional Whitening dentifrice

in-office bleaching with the whitening dentifrice containing blue covarine 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.

Whitening dentifrice containing blue covarine

in-office bleaching with the regular dentifrice 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.

Regular dentifrice

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hao Yu

  Fujian Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fujian Medical University

Model Details: factorial assignment

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 22, 2017
• Study Start: January 18, 2017
• Primary Completion: July 2, 2017
• Study Completion: August 24, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

CN (1)