Tooth DiscolorationPhase 4NCT03163069
The Effect of Whitening Toothpaste on Tooth Color Associated With Bleaching Process
A Phase 4 study testing in-office bleaching with the conventional whitening dentifrice, in-office bleaching with the whitening dentifrice containing blue covarine and in-office bleaching with the regular dentifrice in people with Tooth Discoloration, run by Fujian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- in-office bleaching with the conventional whitening dentifrice, in-office bleaching with the whitening dentifrice containing blue covarine and in-office bleaching with the regular dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2017to 24 Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Use of a Whitening Dentifrice Improve the Efficiency of In-office Tooth Bleaching Procedures? A Double-blind Randomized Controlled Clinical Trial.
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.
Read the 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).
- Conditions
- Tooth Discoloration
- Being tested
- 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
- Keywords
- tooth bleaching, dentifrice
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-office bleaching with the conventional whitening dentifriceCombination product
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.
in-office bleaching with the whitening dentifrice containing blue covarineCombination product
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.
in-office bleaching with the regular dentifriceCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Whitening dentifrice | Experimental | in-office bleaching with the conventional whitening dentifrice Receives: Combination Product: in-office bleaching with the conventional whitening dentifrice |
| Whitening dentifrice containing blue covarine | Experimental | in-office bleaching with the whitening dentifrice containing blue covarine Receives: Combination Product: in-office bleaching with the whitening dentifrice containing blue covarine |
| Regular dentifrice | Experimental | in-office bleaching with the regular dentifrice Receives: Combination Product: in-office bleaching with the regular dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (1)
Change in tooth whiteness
The whiteness index will be registered at the sessions and the baseline.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start18 Jan 2017
- Primary completion2 Jul 2017
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- factorial assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Yu, Fujian Medical University
- Investigators
- Hao Yu, Principal investigator, Fujian Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163069
- Sponsor's protocol ID
- 20170318
- Status last verified
- Oct 2017
- First submitted
- 16 May 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jiang NW, Cheng YL, Huang HL, Zhong BJ, Bi W, Yu H. Correlation between patient satisfaction and color changes after tooth bleaching. J Esthet Restor Dent. 2024 Mar;36(3):437-444. doi: 10.1111/jerd.13200. Epub 2024 Feb 1.
PubMed 38303586
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Use of a Whitening Dentifrice Improve the Efficiency of In-office Tooth Bleaching Procedures? A Double-blind Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03163069
- Acronym / sponsor ID
- 20170318
- Conditions
- Tooth Discoloration
- Keywords
- tooth bleaching, dentifrice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 2 Jul 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- factorial assignment
| Arm | Type | Receives |
|---|---|---|
| Conventional Whitening dentifrice | Experimental | Combination Product: in-office bleaching with the conventional whitening dentifricein-office bleaching with the conventional whitening dentifrice |
| Whitening dentifrice containing blue covarine | Experimental | Combination Product: in-office bleaching with the whitening dentifrice containing blue covarinein-office bleaching with the whitening dentifrice containing blue covarine |
| Regular dentifrice | Experimental | Combination Product: in-office bleaching with the regular dentifricein-office bleaching with the regular dentifrice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-office bleaching with the conventional whitening dentifriceParticipants 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. | Combination product | Conventional Whitening dentifrice |
| in-office bleaching with the whitening dentifrice containing blue covarineParticipants 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. | Combination product | Whitening dentifrice containing blue covarine |
| in-office bleaching with the regular dentifriceParticipants 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. | Combination product | Regular dentifrice |
Primary outcome
Change in tooth colour
Time frame: 4 weeks
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).
1 secondary outcome
Change in tooth whiteness
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Derived from this study: PubMed 38303586Jiang NW, Cheng YL, Huang HL, Zhong BJ, Bi W, Yu H. Correlation between patient satisfaction and color changes after tooth bleaching. J Esthet Restor Dent. 2024 Mar;36(3):437-444. doi: 10.1111/jerd.13200. Epub 2024 Feb 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Yu principal investigator
Fujian Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing in-office bleaching with the conventional whitening dentifrice, in-office bleaching with the whitening dentifrice containing blue covarine and in-office bleaching with the regular dentifrice in people with Tooth Discoloration, run by Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tooth colour (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.