Tooth DiscolorationPhase 4NCT02741427
Efficacy of a Whitening Dentifrice on Tooth Discoloration
A Phase 4 study testing Conventional toothpaste, Whitening toothpaste and 10% carbamide peroxide in people with Tooth Discoloration, run by Federal University of Paraíba.
Trial summary
The purpose of this study was to compare the whitening effect of a toothpaste containing blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the subject's perception about tooth color improvement and; and evaluate the safety and acceptability of these products. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Conventional toothpaste, Whitening toothpaste and 10% carbamide peroxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Aug 2014
- 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
- To have six maxillary anterior teeth with a mean shade of C1 or darker (Vitapan Classical, Vita Zahnfabrik, Bad Sackingen, Germany),
Who cannot join
- With active caries or periodontal disease,
- Presenting non-vital anterior teeth,
- Previous hypersensitivity,
- Under orthodontic treatment,
- With structural defect in the enamel,
- Who had used tooth whiteners within the previous 3 years,
- Smokers,
- Pregnant or lactating
About this study
Official title: Safety, Acceptability and Efficacy of a Silica Dentifrice Containing Blue Pigment on Tooth Whitening: a Randomized Clinical Trial
The purpose of this study was to compare the whitening effect of a toothpaste containing blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the subject's perception about tooth color improvement and; and evaluate the safety and acceptability of these products.
Read the detailed description
The study was approved by local Ethical Committee under protocol number CAAE: 035541412.7.0000.5188, and each volunteer signed an informed consent form prior to enrollment in the study.
The sample size calculation was carried out based on a previous study. To detect the bleaching effect with a power of 80% and a one-tailed alpha error of 5%, a sample size of 20 subjects in each treatment group was necessary to detect a 20% difference between groups in shade change. A 20% addiction in subjects' number, taking into consideration potential loss or refusal, gave a total sample size of 75 subjects (25 in each group). The individuals were invited to participate in this clinical trial through advertisement exposed at the Federal University of Paraíba, Brazil.
Basing on eligibility criteria, 75 volunteers were selected to the trial and randomized to one of the three groups of treatment: G1- brushing teeth with a conventional toothpaste; G2- brushing teeth with a silica whitening dentifrice containing blue pigment; and G3 - at-home tooth bleaching with 10% carbamide peroxide. The treatments will be detailed in another section. It was used a simple randomization to allocate the subjects, and a randomization table was prepared in the Excel Program by a member, not directly involved with the clinical part of the study.
To mask the products used in the treatment groups, each toothpaste type was enveloped with an adhesive tape of a different color and the seal of the bleaching gel syringe was removed. The same examiner responsible for subject allocation did this procedure. Thus, testing with the toothpastes was double-blinded, where both evaluator and subject did not know which toothpaste was being used.
The outcomes evaluated were: tooth shade, subjects' perception about tooth color appearance, and safety and acceptability of products tested, which were measured at baseline, 2-weeks, 3-weeks and 4-weeks of the beginning of treatments.
For statistical analysis, data were checked for normal distribution using the Kolmogorov Smirnov test, and then it was applied the appropriated parametric or non-parametric tests. Differences were considered statistically significant when p < 0.05.
- Conditions
- Tooth Discoloration
- Being tested
- Conventional toothpaste, Whitening toothpaste, 10% carbamide peroxide
- Keywords
- Tooth discoloration, Toothpaste, Tooth bleaching, Clinical trial
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional toothpasteOther
Also called Colgate Máxima Proteção Anticáries
The participants should brush their teeth with conventional toothpaste for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on their toothbrushes, use dental floss, but not mouth rinse.
Whitening toothpasteOther
Also called Close up White Now
The subjects should brush teeth with whitening toothpaste containing blue pigment for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on toothbrushes, use dental floss, but not mouth rinse.
10% carbamide peroxideOther
Also called Whiteness perfect 10%
The subjects should dispense the bleaching gel at night into the trays (maxillary and mandibular) and to insert them to cover at least the anterior teeth for a period of 4 h per day, over a 2-week period. Both arches should be bleached at the same time. During the period of bleaching, volunteers should receive the same toothpaste used by G1, in other words, without "whitening agents", to standardize their oral hygiene regimen
| Study group | Role | What they receive |
|---|---|---|
| G1 (group 1) - Conventional toothpaste | Placebo comparator | G1 used a conventional toothpaste in daily oral regimen Receives: Other: Conventional toothpaste |
| G2 (group 2) - Whitening toothpaste | Experimental | G2 used a whitening toothpaste containing blue pigment in daily oral regimen Receives: Other: Whitening toothpaste |
| G3 (group 3) - 10 % Carbamide peroxide | Active comparator | G3 made an at-home tooth bleaching with 10 % Carbamide peroxide Receives: Other: 10% carbamide peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth shade changes from baseline until 4 weeks of the beginning of intervention
The tooth shade evaluation was performed at each time frame using the digital spectrophotometer that provided tooth shade via two different methods: using the 16 shade tabs in the Vita shade guide (B1-C4); and the CIEL*a*b* color system. The difference between the color coordinates was calculated as: ∆E*= [(∆L*)2 + (∆a*)2 + (∆b*)2]1/2, where ΔL*, Δa*, and Δb* are the mathematical differences among CIE L*, a*, and b* at the different time frames and baseline measurements.
Measured: Baseline, Immediately after first product application, 2 weeks and 4 weeks of the beginning of interventions
Secondary outcomes (3)
Subjects' perception about improvement on tooth color
After two weeks of treatment, the subjects received a visual analog scale (VAS) ranging from 1 (no improvement in tooth appearance) to 7 (exceptional improvement in tooth appearance), in order to evaluate their satisfaction level with tooth appearance
Measured: 2 weeks of the beginning of interventions
Tooth sensitivity and gingival irritation evaluation
Each subject should record tooth sensitivity or gingival irritation on a daily basis for 3 weeks (2 weeks of treatment and 1 week after treatment). They should use a standardized grading scale ranked as follows: 0, no sensitivity; 1, mild sensitivity; 2, moderate sensitivity; 3, considerable sensitivity; and 4, severe sensitivity
Measured: Daily during three weeks
Acceptability of interventions
The acceptability of the three products was assessed using a questionnaire containing six questions about the opinion of subjects regarding the treatment regimen adopted. The questions were scored from positive to negative answers, as follows: 1, agree; 2, neither agree nor disagree; and 3, disagree. The questions related to sufficient instruction, ease of use, comfort level, perceived taste, and overall satisfaction.
Measured: 2 weeks of the beginning of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionAug 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Principal investigator, Jossaria Pereira de Sousa, Federal University of Paraíba
- Investigators
- Jossaria P Sousa, Master, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741427
- Sponsor's protocol ID
- FUofParabia
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Meireles SS, Santos IS, Bona AD, Demarco FF. A double-blind randomized clinical trial of two carbamide peroxide tooth bleaching agents: 2-year follow-up. J Dent. 2010 Dec;38(12):956-63. doi: 10.1016/j.jdent.2010.08.003. Epub 2010 Aug 13.
PubMed 20709137Walsh TF, Rawlinson A, Wildgoose D, Marlow I, Haywood J, Ward JM. Clinical evaluation of the stain removing ability of a whitening dentifrice and stain controlling system. J Dent. 2005 May;33(5):413-8. doi: 10.1016/j.jdent.2004.10.021. Epub 2004 Dec 20.
PubMed 15833397
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Acceptability and Efficacy of a Silica Dentifrice Containing Blue Pigment on Tooth Whitening: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02741427
- Acronym / sponsor ID
- FUofParabia
- Conditions
- Tooth Discoloration
- Keywords
- Tooth discoloration, Toothpaste, Tooth bleaching, Clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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 purpose of this study was to compare the whitening effect of a toothpaste containing blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the subject's perception about tooth color improvement and; and evaluate the safety and acceptability of these products.
Detailed description
The study was approved by local Ethical Committee under protocol number CAAE: 035541412.7.0000.5188, and each volunteer signed an informed consent form prior to enrollment in the study.
The sample size calculation was carried out based on a previous study. To detect the bleaching effect with a power of 80% and a one-tailed alpha error of 5%, a sample size of 20 subjects in each treatment group was necessary to detect a 20% difference between groups in shade change. A 20% addiction in subjects' number, taking into consideration potential loss or refusal, gave a total sample size of 75 subjects (25 in each group). The individuals were invited to participate in this clinical trial through advertisement exposed at the Federal University of Paraíba, Brazil.
Basing on eligibility criteria, 75 volunteers were selected to the trial and randomized to one of the three groups of treatment: G1- brushing teeth with a conventional toothpaste; G2- brushing teeth with a silica whitening dentifrice containing blue pigment; and G3 - at-home tooth bleaching with 10% carbamide peroxide. The treatments will be detailed in another section. It was used a simple randomization to allocate the subjects, and a randomization table was prepared in the Excel Program by a member, not directly involved with the clinical part of the study.
To mask the products used in the treatment groups, each toothpaste type was enveloped with an adhesive tape of a different color and the seal of the bleaching gel syringe was removed. The same examiner responsible for subject allocation did this procedure. Thus, testing with the toothpastes was double-blinded, where both evaluator and subject did not know which toothpaste was being used.
The outcomes evaluated were: tooth shade, subjects' perception about tooth color appearance, and safety and acceptability of products tested, which were measured at baseline, 2-weeks, 3-weeks and 4-weeks of the beginning of treatments.
For statistical analysis, data were checked for normal distribution using the Kolmogorov Smirnov test, and then it was applied the appropriated parametric or non-parametric tests. Differences were considered statistically significant when p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G1 (group 1) - Conventional toothpaste | Placebo comparator | Other: Conventional toothpasteG1 used a conventional toothpaste in daily oral regimen |
| G2 (group 2) - Whitening toothpaste | Experimental | Other: Whitening toothpasteG2 used a whitening toothpaste containing blue pigment in daily oral regimen |
| G3 (group 3) - 10 % Carbamide peroxide | Active comparator | Other: 10% carbamide peroxideG3 made an at-home tooth bleaching with 10 % Carbamide peroxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To have six maxillary anterior teeth with a mean shade of C1 or darker (Vitapan Classical, Vita Zahnfabrik, Bad Sackingen, Germany),
Key exclusion criteria (8 listed)
- With active caries or periodontal disease,
- Presenting non-vital anterior teeth,
- Previous hypersensitivity,
- Under orthodontic treatment,
- With structural defect in the enamel,
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 |
|---|---|---|
| Conventional toothpasteAlso: Colgate Máxima Proteção AnticáriesThe participants should brush their teeth with conventional toothpaste for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on their toothbrushes, use dental floss, but not mouth rinse. | Other | G1 (group 1) - Conventional toothpaste |
| Whitening toothpasteAlso: Close up White NowThe subjects should brush teeth with whitening toothpaste containing blue pigment for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on toothbrushes, use dental floss, but not mouth rinse. | Other | G2 (group 2) - Whitening toothpaste |
| 10% carbamide peroxideAlso: Whiteness perfect 10%The subjects should dispense the bleaching gel at night into the trays (maxillary and mandibular) and to insert them to cover at least the anterior teeth for a period of 4 h per day, over a 2-week period. Both arches should be bleached at the same time. During the period of bleaching, volunteers should receive the same toothpaste used by G1, in other words, without "whitening agents", to standardize their oral hygiene regimen | Other | G3 (group 3) - 10 % Carbamide peroxide |
Primary outcome
Tooth shade changes from baseline until 4 weeks of the beginning of intervention
Time frame: Baseline, Immediately after first product application, 2 weeks and 4 weeks of the beginning of interventions
The tooth shade evaluation was performed at each time frame using the digital spectrophotometer that provided tooth shade via two different methods: using the 16 shade tabs in the Vita shade guide (B1-C4); and the CIEL*a*b* color system. The difference between the color coordinates was calculated as: ∆E*= [(∆L*)2 + (∆a*)2 + (∆b*)2]1/2, where ΔL*, Δa*, and Δb* are the mathematical differences among CIE L*, a*, and b* at the different time frames and baseline measurements.
3 secondary outcomes
Subjects' perception about improvement on tooth color
Time frame: 2 weeks of the beginning of interventions
Tooth sensitivity and gingival irritation evaluation
Time frame: Daily during three weeks
Acceptability of interventions
Time frame: 2 weeks of the beginning of interventions
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 18 Apr 2016.
- Background: PubMed 20709137Meireles SS, Santos IS, Bona AD, Demarco FF. A double-blind randomized clinical trial of two carbamide peroxide tooth bleaching agents: 2-year follow-up. J Dent. 2010 Dec;38(12):956-63. doi: 10.1016/j.jdent.2010.08.003. Epub 2010 Aug 13.
- Background: PubMed 15833397Walsh TF, Rawlinson A, Wildgoose D, Marlow I, Haywood J, Ward JM. Clinical evaluation of the stain removing ability of a whitening dentifrice and stain controlling system. J Dent. 2005 May;33(5):413-8. doi: 10.1016/j.jdent.2004.10.021. Epub 2004 Dec 20.
- Individual participant dataSharing planned: No
Related trials for Tooth Discoloration
Not yet recruiting
Children Acceptance of AgNP Mouthwash Against Chlorhexidine 0.12% and Chlorhexidine .2% Mouthwashs
Teeth Staining, Numbness of the Tongue and Soft Tissue
Not yet recruiting
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Gingivitis, Healthy Adult
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
A Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up
Tooth Discoloration
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
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.
Jossaria P Sousa, Master principal investigator
Federal University of Paraiba
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional toothpaste, Whitening toothpaste and 10% carbamide peroxide in people with Tooth Discoloration, run by Federal University of Paraíba.
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 8 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 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Tooth shade changes from baseline until 4 weeks of the beginning of intervention (time frame: Baseline, Immediately after first product application, 2 weeks and 4 weeks of the beginning of interventions). 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 NCT02741427, 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 18 Apr 2016.