Tooth BleachingNCT05021965
The Effectiveness of At-home , In-office and Combined Dental Bleaching System ：A Randomized Controlled Clinical Trial
A study testing different combined of tooth bleaching procedure in people with Tooth Bleaching, run by Fujian Medical University at 1 site in China.
Trial summary
This randomized controlled clinical trial aimed to investigate the effectiveness of at-home , in-office and combined dental bleaching system. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching
- What is being tested?
- different combined of tooth bleaching procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 14 Mar 2022
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant or lactating women , people with known allergy to the product ingredients, smokers, and alcohol abusers, had severe internal tooth discoloration (e.g. tetracycline stains), had bruxism or any other pathology that could cause TS (such as gingival recession or dentin exposure).
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled clinical trial aimed to investigate the effectiveness of at-home , in-office and combined dental bleaching system.
Read the detailed description
The participants with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 4 groups according to the different tooth bleaching protocol：at-home bleaching for group 1,in-office bleaching for group 2 ,combined bleaching for group 3 and group 4.Participates in group 1 will receive two weeks of at-home tooth bleaching （Lasts 14 days and at least 8 hours every day ）with 10% Carbamide peroxide(Opalescence PF 10%) , group 2 will receive two sessions （with a 1- week interval ）of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)，group 3 will receive one week of at-home tooth bleaching （Lasts 7 days and at least 8 hours every day ）and then the eighth day receive one session of in-office tooth bleaching , group 4 receive one session of in-office bleaching and lasts 7 days at-home bleaching start on the eighth day . 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 month after the completion of bleaching (T4). CIEDE2000 colour difference (△E00), the Whiteness Index for Dentistry (WID) and Tooth sensitivity (TS) will also be calculated. The data will be statistically analysed through repeated ANOVA and Tukey's test (α = 0.05).
- Conditions
- Tooth Bleaching
- Being tested
- different combined of tooth bleaching procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different combined of tooth bleaching procedureProcedure or surgery
The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.
| Study group | Role | What they receive |
|---|---|---|
| group 1: have two weeks of at-home tooth bleaching | Experimental | Participants will receive two weeks of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%) for the maxillary anterior teeth. Receives: Procedure: different combined of tooth bleaching procedure |
| group 2 : have two sessions of in-office tooth bleaching | Experimental | Participants will receive two sessions（with a 1- week interval ） of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)for the maxillary anterior teeth. Receives: Procedure: different combined of tooth bleaching procedure |
| group 3 : one week of at-home and then have one session of in-office tooth bleaching | Experimental | Participants will receive one week of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%) and then receive one session of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)for the maxillary anterior teeth. Receives: Procedure: different combined of tooth bleaching procedure |
| group 4 : one week of in-office and then have one session of at-home tooth bleaching | Experimental | Participants will receive one session of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) and a week later receive one week of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%)for the maxillary anterior teeth. Receives: Procedure: different combined of tooth bleaching procedure |
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: six weeks
Secondary outcomes (1)
Tooth sensitivity evaluation
Using the visual analogue scale (VAS) record the Tooth sensitivity (TS) throughout the entire treatment
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start15 Jul 2021
- Primary completion5 Jan 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth BleachingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 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, PhD, Principal investigator, Fujian Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021965
- Sponsor's protocol ID
- 20210715
- Status last verified
- Sep 2023
- First submitted
- 20 Aug 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of At-home , In-office and Combined Dental Bleaching System ：A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05021965
- Acronym / sponsor ID
- 20210715
- Conditions
- Tooth Bleaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 26 Aug 2021 (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 randomized controlled clinical trial aimed to investigate the effectiveness of at-home , in-office and combined dental bleaching system.
Detailed description
The participants with at least one maxillary tooth demonstrating shade A3 or darker will be recruited and randomly allocated into 4 groups according to the different tooth bleaching protocol：at-home bleaching for group 1,in-office bleaching for group 2 ,combined bleaching for group 3 and group 4.Participates in group 1 will receive two weeks of at-home tooth bleaching （Lasts 14 days and at least 8 hours every day ）with 10% Carbamide peroxide(Opalescence PF 10%) , group 2 will receive two sessions （with a 1- week interval ）of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)，group 3 will receive one week of at-home tooth bleaching （Lasts 7 days and at least 8 hours every day ）and then the eighth day receive one session of in-office tooth bleaching , group 4 receive one session of in-office bleaching and lasts 7 days at-home bleaching start on the eighth day . 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 month after the completion of bleaching (T4). CIEDE2000 colour difference (△E00), the Whiteness Index for Dentistry (WID) and Tooth sensitivity (TS) 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 (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1: have two weeks of at-home tooth bleaching | Experimental | Procedure: different combined of tooth bleaching procedureParticipants will receive two weeks of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%) for the maxillary anterior teeth. |
| group 2 : have two sessions of in-office tooth bleaching | Experimental | Procedure: different combined of tooth bleaching procedureParticipants will receive two sessions（with a 1- week interval ） of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)for the maxillary anterior teeth. |
| group 3 : one week of at-home and then have one session of in-office tooth bleaching | Experimental | Procedure: different combined of tooth bleaching procedureParticipants will receive one week of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%) and then receive one session of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%)for the maxillary anterior teeth. |
| group 4 : one week of in-office and then have one session of at-home tooth bleaching | Experimental | Procedure: different combined of tooth bleaching procedureParticipants will receive one session of in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) and a week later receive one week of at-home tooth bleaching with 10% Carbamide peroxide(Opalescence PF 10%)for the maxillary anterior teeth. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant or lactating women , people with known allergy to the product ingredients, smokers, and alcohol abusers, had severe internal tooth discoloration (e.g. tetracycline stains), had bruxism or any other pathology that could cause TS (such as gingival recession or dentin exposure).
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 |
|---|---|---|
| different combined of tooth bleaching procedureThe participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol. | Procedure or surgery | group 1: have two weeks of at-home tooth bleaching, group 2 : have two sessions of in-office tooth bleaching, group 3 : one week of at-home and then have one session of in-office tooth bleaching, group 4 : one week of in-office and then have one session of at-home tooth bleaching |
Primary outcome
Change in tooth colour
Time frame: six 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
Tooth sensitivity evaluation
Time frame: two 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 29 Sep 2023.
- Individual participant dataSharing planned: No
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Effect of Prophylaxis Pastes With and Without Desensitizing Agents Prior to In-office Bleaching
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Effect of Bleaching Regimen With Different Activation Modes on Color Stability, Surface Roughness, Tooth Sensitivity and Patient Satisfaction
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Recruiting
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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, PhD 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 study testing different combined of tooth bleaching procedure in people with Tooth Bleaching, 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 29 Sep 2023. 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.
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: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2023.