Tooth BleachingPhase 4NCT03588871
Comparison of the Efficacy and Quality of Life of Three Bleaching Products
A Phase 4 study testing Dental bleaching with PaintOn Plus VivaStyle, Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle and Dental bleaching with Opalescence GO in people with Tooth Bleaching and Quality of Life, run by Grupo de Investigação em Bioquímica e Biologia Oral at 1 site in Portugal.
Trial summary
The aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching, Quality of Life
- What is being tested?
- Dental bleaching with PaintOn Plus VivaStyle, Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle and Dental bleaching with Opalescence GO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2017to 1 Sep 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years old
- Be willing to refrain from use of tobacco products during the study
- Be willing to sign an informed consent form
- At least one teeth 13,11,21,23,33,43 has a gradable VITA shade A3,5 or darker by clinical assessment
Who cannot join
- Teeht with restorations in frontal teeth
- Patients with untreated periodontitis or caries
- Patients with fixed orthodontics appliances
- Patients with know allergies to ingredients
- Patients who are nursing or pregnant
- Patients with severe systemic illnesses
Show all 9Show fewer
- Patients with development tooth anomalies
- Patients with non vital anterior teeth
- Patients with insufficient oral hygiene
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine of the University of Lisboa
Lisbon
João Silveira, Phd, MSc, +351966168040, joao.silveira@campus.ul.pt
António Mata, PhD, MSc
About this study
The aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments.
Products to be used represent three different techniques and formulations: in office, universal tray and custom tray (respectively VivaStyle Paint On Plus (Ivoclar Vivadent, Liechtenstein), Opalescence GO 6% (Ultradent, USA) and Opalescence PF 15% (Ultradent, USA).
All products contain 6% hydrogen peroxide or its equivalent.
- Conditions
- Tooth Bleaching, Quality of Life
- Being tested
- Dental bleaching with PaintOn Plus VivaStyle, Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle, Dental bleaching with Opalescence GO, Dental Bleaching impact in quality of life with Opalescence GO, Dental bleaching with Opalescence PF
- Keywords
- Tooth bleaching, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental bleaching with PaintOn Plus VivaStyleOther
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent)
Dental Bleaching impact in quality of life with PaintOn Plus VivastyleOther
Evaluation of oral quality of life after dental bleaching treatment with PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14
Dental bleaching with Opalescence GOOther
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent)
Dental Bleaching impact in quality of life with Opalescence GOOther
Evaluation of oral quality of life after dental bleaching treatment with Opalescence GO 6% HP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14
Dental bleaching with Opalescence PFOther
Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent)
Dental Bleaching impact in quality of life with Opalescence PFOther
Evaluation of oral quality of life after dental bleaching treatment with Opalescence PF 16% CP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions Receives: Other: Dental bleaching with PaintOn Plus VivaStyle; Other: Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle |
| Group B | Experimental | Dental bleaching with Opalescence GO, HP 6%, 10x60min Receives: Other: Dental bleaching with Opalescence GO; Other: Dental Bleaching impact in quality of life with Opalescence GO |
| Group C | Experimental | Dental bleaching with Opalescence PF, CP 16%, 14x60h Receives: Other: Dental bleaching with Opalescence PF; Other: Dental Bleaching impact in quality of life with Opalescence PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on visually determination of tooth colour
Determination of tooth colour using a visual tooth shade guide
Measured: 2 weeks (before and after treatment)
Change on spectrophotometer determination of tooth colour
Determination of tooth colour using a spectrophotometer
Measured: 2 weeks (before and after treatment)
Subjective evaluation of tooth colour change during follow-up
Determination of tooth colour relapse using visual tooth shade guide (VITA shade guide)
Measured: 1, 3 and 6 months
Change on quality of life during treatment and follow-up
Impact on quality of life using an oral quality of life measuring questionnaire, the Oral Health Impact Profile 14 (OHIP-14). The OHIP-14 ranges from 0 to 56 (final sum of all the seven subscales), with higher scores indicating poorer quality of life.
Measured: 2 weeks (before and after treatment), 1 month, 3 months and 6 months
Objective evaluation of tooth colour change during follow-up
Determination of tooth colour relapse using a spectrophotometer
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Sep 2017
- Primary completion1 May 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia Oral
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588871
- Sponsor's protocol ID
- BL16001
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Quality of Life of Three Bleaching Products
- ClinicalTrials.gov ID
- NCT03588871
- Acronym / sponsor ID
- BL16001
- Conditions
- Tooth Bleaching, Quality of Life
- Keywords
- Tooth bleaching, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia OralUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 17 Jul 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.
The aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments.
Products to be used represent three different techniques and formulations: in office, universal tray and custom tray (respectively VivaStyle Paint On Plus (Ivoclar Vivadent, Liechtenstein), Opalescence GO 6% (Ultradent, USA) and Opalescence PF 15% (Ultradent, USA).
All products contain 6% hydrogen peroxide or its equivalent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Dental bleaching with PaintOn Plus VivaStyle, Other: Dental Bleaching impact in quality of life with PaintOn Plus VivastyleDental bleaching with PaintOn Plus, HP 6%, 6x10min, two sessions |
| Group B | Experimental | Other: Dental bleaching with Opalescence GO, Other: Dental Bleaching impact in quality of life with Opalescence GODental bleaching with Opalescence GO, HP 6%, 10x60min |
| Group C | Experimental | Other: Dental bleaching with Opalescence PF, Other: Dental Bleaching impact in quality of life with Opalescence PFDental bleaching with Opalescence PF, CP 16%, 14x60h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years old
- Be willing to refrain from use of tobacco products during the study
- Be willing to sign an informed consent form
- At least one teeth 13,11,21,23,33,43 has a gradable VITA shade A3,5 or darker by clinical assessment
Key exclusion criteria (9 listed)
- Teeht with restorations in frontal teeth
- Patients with untreated periodontitis or caries
- Patients with fixed orthodontics appliances
- Patients with know allergies to ingredients
- Patients who are nursing or pregnant
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 |
|---|---|---|
| Dental bleaching with PaintOn Plus VivaStyleProcedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent) | Other | Group A |
| Dental Bleaching impact in quality of life with PaintOn Plus VivastyleEvaluation of oral quality of life after dental bleaching treatment with PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14 | Other | Group A |
| Dental bleaching with Opalescence GOProcedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent) | Other | Group B |
| Dental Bleaching impact in quality of life with Opalescence GOEvaluation of oral quality of life after dental bleaching treatment with Opalescence GO 6% HP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14 | Other | Group B |
| Dental bleaching with Opalescence PFProcedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent) | Other | Group C |
| Dental Bleaching impact in quality of life with Opalescence PFEvaluation of oral quality of life after dental bleaching treatment with Opalescence PF 16% CP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14 | Other | Group C |
Primary outcome
Change on visually determination of tooth colour
Time frame: 2 weeks (before and after treatment)
Determination of tooth colour using a visual tooth shade guide
Change on spectrophotometer determination of tooth colour
Time frame: 2 weeks (before and after treatment)
Determination of tooth colour using a spectrophotometer
Subjective evaluation of tooth colour change during follow-up
Time frame: 1, 3 and 6 months
Determination of tooth colour relapse using visual tooth shade guide (VITA shade guide)
Change on quality of life during treatment and follow-up
Time frame: 2 weeks (before and after treatment), 1 month, 3 months and 6 months
Impact on quality of life using an oral quality of life measuring questionnaire, the Oral Health Impact Profile 14 (OHIP-14). The OHIP-14 ranges from 0 to 56 (final sum of all the seven subscales), with higher scores indicating poorer quality of life.
Objective evaluation of tooth colour change during follow-up
Time frame: 1, 3 and 6 months
Determination of tooth colour relapse using a spectrophotometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- 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.
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 Dental bleaching with PaintOn Plus VivaStyle, Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle and Dental bleaching with Opalescence GO in people with Tooth Bleaching and Quality of Life, run by Grupo de Investigação em Bioquímica e Biologia Oral at 1 site in Portugal.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Jul 2018. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Silveira, PhD, MSc (+351966168040, joao.silveira@campus.ul.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on visually determination of tooth colour (time frame: 2 weeks (before and after treatment)). The study lists 5 primary outcomes in all. 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 17 Jul 2018.