The Effect of Staining Beverage on Color Alteration During In-office Tooth Bleaching
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2019
CompletedFirst Submitted
Initial submission to the registry
April 27, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedMay 1, 2019
April 1, 2019
2 months
April 27, 2019
April 27, 2019
Conditions
Keywords
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)
control group
NO INTERVENTIONParticipants 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).
coffee group
EXPERIMENTALParticipants 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.
tea group
EXPERIMENTALParticipants 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.
Interventions
the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.
Eligibility Criteria
You may qualify if:
- 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
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University
Fuzhou, Fujian, 350004, China
Related Publications (1)
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.
PMID: 32169479DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hao Yu
Fujian Medical University, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fujian Medical University
Study Record Dates
First Submitted
April 27, 2019
First Posted
May 1, 2019
Study Start
February 14, 2019
Primary Completion
April 10, 2019
Study Completion
April 14, 2019
Last Updated
May 1, 2019
Record last verified: 2019-04