NCT03933527

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 27, 2019

Last Update Submit

April 27, 2019

Conditions

Keywords

tooth bleachingstaining beverage

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 INTERVENTION

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).

coffee group

EXPERIMENTAL

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.

Behavioral: making staining beverage rinse during in-office tooth bleaching

tea group

EXPERIMENTAL

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.

Behavioral: making staining beverage rinse during in-office tooth bleaching

Interventions

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

coffee grouptea group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Hao Yu

    Fujian Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: factorial assignment
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

Locations