The Effect of Whitening Toothpaste on Tooth Color Associated With Bleaching Process
Primary Purpose
Tooth Discoloration
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
in-office bleaching with the conventional whitening dentifrice
in-office bleaching with the whitening dentifrice containing blue covarine
in-office bleaching with the regular dentifrice
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Discoloration focused on measuring tooth bleaching, dentifrice
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.
Sites / Locations
- Fujian Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Conventional Whitening dentifrice
Whitening dentifrice containing blue covarine
Regular dentifrice
Arm Description
in-office bleaching with the conventional whitening dentifrice
in-office bleaching with the whitening dentifrice containing blue covarine
in-office bleaching with the regular dentifrice
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in tooth whiteness
The whiteness index will be registered at the sessions and the baseline.
Full Information
NCT ID
NCT03163069
First Posted
May 16, 2017
Last Updated
October 7, 2017
Sponsor
Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03163069
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 18, 2017 (Actual)
Primary Completion Date
July 2, 2017 (Actual)
Study Completion Date
August 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
Keywords
tooth bleaching, dentifrice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
factorial assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Whitening dentifrice
Arm Type
Experimental
Arm Description
in-office bleaching with the conventional whitening dentifrice
Arm Title
Whitening dentifrice containing blue covarine
Arm Type
Experimental
Arm Description
in-office bleaching with the whitening dentifrice containing blue covarine
Arm Title
Regular dentifrice
Arm Type
Experimental
Arm Description
in-office bleaching with the regular dentifrice
Intervention Type
Combination Product
Intervention Name(s)
in-office bleaching with the conventional whitening dentifrice
Intervention Description
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
Intervention Name(s)
in-office bleaching with the whitening dentifrice containing blue covarine
Intervention Description
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
Intervention Name(s)
in-office bleaching with the regular dentifrice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in tooth colour
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in tooth whiteness
Description
The whiteness index will be registered at the sessions and the baseline.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Yu
Organizational Affiliation
Fujian Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Whitening Toothpaste on Tooth Color Associated With Bleaching Process
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