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

NCT ID: NCT03933527

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2019-04-14

Brief Summary

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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

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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).

Conditions

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Tooth Discoloration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

factorial assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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control group

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

coffee group

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.

Group Type EXPERIMENTAL

making staining beverage rinse during in-office tooth bleaching

Intervention Type BEHAVIORAL

the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.

tea group

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.

Group Type EXPERIMENTAL

making staining beverage rinse during in-office tooth bleaching

Intervention Type BEHAVIORAL

the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.

Interventions

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making staining beverage rinse during in-office tooth bleaching

the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hao Yu

Fujian Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hao Yu

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University, China

Locations

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Fujian Medical University

Fuzhou, Fujian, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 32169479 (View on PubMed)

Other Identifiers

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20190214

Identifier Type: -

Identifier Source: org_study_id

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