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The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching

Primary Purpose

Tooth Discoloration

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
making staining beverage rinse during in-office tooth bleaching
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring tooth bleaching, staining beverage

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients between 18 and 30 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

No Intervention

Experimental

Experimental

Arm Label

control group

coffee group

tea group

Arm 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).

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 make coffee rinses for 30 seconds, four times daily.

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 make tea rinses for 30 seconds, four times daily.

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

First Posted
April 27, 2019
Last Updated
April 27, 2019
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03933527
Brief Title
The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching
Official Title
The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching: A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
April 14, 2019 (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 staining beverage on color alteration of in-office tooth bleaching procedures.
Detailed Description
Sixty-three eligible participants (25 males and 38 females, mean age 26.5 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 staining beverage used in this clinical trial: Coffee for group C, Tea for group T, and distilled water for group W. 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 beverage rinses for 30 seconds, four times daily. 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, staining beverage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
factorial assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm 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).
Arm Title
coffee group
Arm Type
Experimental
Arm 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 make coffee rinses for 30 seconds, four times daily.
Arm Title
tea group
Arm Type
Experimental
Arm 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 make tea rinses for 30 seconds, four times daily.
Intervention Type
Behavioral
Intervention Name(s)
making staining beverage rinse during in-office tooth bleaching
Intervention Description
the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.
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
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients between 18 and 30 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
Citations:
PubMed Identifier
32169479
Citation
Chen YH, Yang S, Hong DW, Attin T, Yu H. Short-term effects of stain-causing beverages on tooth bleaching: A randomized controlled clinical trial. J Dent. 2020 Apr;95:103318. doi: 10.1016/j.jdent.2020.103318. Epub 2020 Mar 10.
Results Reference
derived

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The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching

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