Tooth DiscolorationPhase 4NCT03514797
Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color
A Phase 4 study testing Bleaching Agents in people with Tooth Discoloration, run by André Luis Faria e Silva at 1 site in Brazil.
Trial summary
This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Bleaching Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Apr 2018to 30 Jun 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general and oral health;
- Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.
Who cannot join
- Presence of non-treated caries or periodontal disease;
- Prior tooth hypersensitivity;
- Presence of gingival recession;
- Teeth with cracked enamel or any hypoplasia;
- Patients using oral removable or fixed orthodontic appliances;
- Patients were pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching
This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.
- Conditions
- Tooth Discoloration
- Being tested
- Bleaching Agents
- Keywords
- Tooth bleaching, Hydrogen peroxide, Carbamide peroxide, Tooth Bleaching Agents
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleaching AgentsDrug
In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.
Bleaching AgentsDrug
At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.
| Study group | Role | What they receive |
|---|---|---|
| Combined technique | Experimental | A single session of in-office tooth bleaching will be performed with 35% hydrogen peroxide for 45 minutes. Following, the teeth will be further bleached with customized trays filled with 10% carbamide peroxide and used for 1h per day. Receives: Drug: Bleaching Agents |
| At-home bleaching | Active comparator | The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day. Receives: Drug: Bleaching Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to tooth color satisfaction
Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained
Measured: up to 1 month after beginning the tooth bleaching procedures
Secondary outcomes (2)
Color change
Values of delta E measured with a spectrophotometer from color at baseline
Measured: up to 1 month after beginning the tooth bleaching procedures
Tooth sensitivity
Maximum level of tooth sensitivity reported by participants using an analogue visual scale. The distance between the patient's marking and the no pain border was recorded in cm.
Measured: 1, 2, 3, and 4 week after beginning the tooth bleaching procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start13 Apr 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- André Luis Faria e Silva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, André Luis Faria e Silva, Universidade Federal de Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514797
- Sponsor's protocol ID
- Combined bleaching
- Status last verified
- Apr 2019
- First submitted
- 13 Apr 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined Bleaching Technique Using Low and High Hydrogen Peroxide In-Office Bleaching Gel. Oper Dent. 2016 Jul-Aug;41(4):388-96. doi: 10.2341/15-266-C. Epub 2016 Feb 26.
PubMed 26919081Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.
PubMed 20884923
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching
- ClinicalTrials.gov ID
- NCT03514797
- Acronym / sponsor ID
- Combined bleaching
- Conditions
- Tooth Discoloration
- Keywords
- Tooth bleaching, Hydrogen peroxide, Carbamide peroxide, Tooth Bleaching Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- André Luis Faria e SilvaUniversity, hospital or other
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 2 May 2018 (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 parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined technique | Experimental | Drug: Bleaching AgentsA single session of in-office tooth bleaching will be performed with 35% hydrogen peroxide for 45 minutes. Following, the teeth will be further bleached with customized trays filled with 10% carbamide peroxide and used for 1h per day. |
| At-home bleaching | Active comparator | Drug: Bleaching AgentsThe teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good general and oral health;
- Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.
Key exclusion criteria (6 listed)
- Presence of non-treated caries or periodontal disease;
- Prior tooth hypersensitivity;
- Presence of gingival recession;
- Teeth with cracked enamel or any hypoplasia;
- Patients using oral removable or fixed orthodontic appliances;
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 |
|---|---|---|
| Bleaching AgentsIn-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes. | Drug | Combined technique |
| Bleaching AgentsAt-home tooth bleaching with 10% carbamide peroxide for 1 hour per day. | Drug | At-home bleaching, Combined technique |
Primary outcome
Time to tooth color satisfaction
Time frame: up to 1 month after beginning the tooth bleaching procedures
Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained
2 secondary outcomes
Color change
Time frame: up to 1 month after beginning the tooth bleaching procedures
Tooth sensitivity
Time frame: 1, 2, 3, and 4 week after beginning the tooth bleaching procedures
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 19 Apr 2019.
- Background: PubMed 26919081Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined Bleaching Technique Using Low and High Hydrogen Peroxide In-Office Bleaching Gel. Oper Dent. 2016 Jul-Aug;41(4):388-96. doi: 10.2341/15-266-C. Epub 2016 Feb 26.
- Background: PubMed 20884923Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bleaching Agents in people with Tooth Discoloration, run by André Luis Faria e Silva at 1 site in Brazil.
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 2 inclusion and 6 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 19 Apr 2019. 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 Brazil. 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?
Time to tooth color satisfaction (time frame: up to 1 month after beginning the tooth bleaching procedures). 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 NCT03514797, which also lists 2 linked publications.
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 19 Apr 2019.