Tooth DiscolorationNCT02067715
Effectiveness of Sealed In-office Bleaching Technique: Randomized Controlled Clinical Trial
A study testing Tooth bleaching in people with Tooth Discoloration, run by Universidade Federal de Sergipe at 1 site in Brazil.
Trial summary
Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique reduce the tooth sensitivity when compared to conventional technique, without alters the bleaching efficacy. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Tooth bleaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to May 2015
- 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
- At least 18 years old patients of both genders presenting good general/oral health;
- All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Alemanha)
- Signed the form accepting to participate of this study.
Who cannot join
- Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
- Undergone tooth-whitening procedures;
- Pregnant/lactating;
- Smokers;
- Presence of periodontal diseases;
- Presence of severe tooth discoloration by tetracycline stains or fluorosis;
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- Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure);
- Continuous use of drugs with anti-inflammatory actions.
- Presence of tooth hypersensitivity at baseline measurement;
- Non-attendance to any session of evaluation or bleaching;
Trial locations and contacts
1 site in 1 country.
About this study
Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique reduce the tooth sensitivity when compared to conventional technique, without alters the bleaching efficacy.
Read the detailed description
This is a randomized, single-blind, and controlled trial with a parallel group and an equal allocation rate to receive either one of two treatments, whereas the sealed technique is the experimental intervention and the conventional technique is control one.
PICO Question:
P (Population) - Patients of dentistry service of Federal University of Sergipe.
I: (Intervention) - In-office bleaching using 35% hydrogen peroxide bleaching agent covered with a customized tray.
C: (Control) - In-office bleaching using 35% hydrogen peroxide bleaching agent covered without a customized tray.
O: (Outcomes) - Primary outcomes: presence of tooth sensitivity during the bleaching procedure; Secondary outcome: Bleaching efficacy.
Sample Patients attempted in clinical service of Federal University of Sergipe requiring tooth bleaching will be recruited for this trial. For sample size calculation was considered 80% of test power, significance level of 5%, the presence of tooth sensitivity of 90% at control intervention and 40% at experimental intervention. These levels of sensitivity were based in pilot study. Thus the sample size for a proportions test (SigmaStat 3.5 (Systat Software, Point Richmond, USA) was 17 participants for each intervention.
Randomization Previously to beginning of study, a blocked randomisation list will be created using the website www.sealedenvelope.com, using block size of 4, by an operator different from those who will be perform the bleaching procedures. The bleaching protocol for each participant will be placed into a sealed envelope, while this only will be opened in the moment of bleaching procedure.
Evaluations During the permanence of bleaching agent, the tooth sensitivity will be monitored and the scores (VAS and verbal scale) will be recorded at 20th and 40th minute. The score also will be recorded immediately after the bleaching agent removal. In the after day, the participants will be argued (only verbal scale) about the maximum level of sensitivity during the first 24 hours after bleaching procedure and in 24th hour after this. A week after the bleaching procedure, the scores based on shade guides will be recorded again. For CIE L*a*b* measurement, ΔE will be calculated by the following equation: ∆E= [(∆L)2 + (∆a)2 + (∆b)2]1/2, while ∆L = L1 - L0; ∆a = a1 - a0; e ∆b = b1 - b0. After the shade evaluation, a new bleaching procedure, using the same protocol, will be performed in this second appointment and the same measurements of tooth sensitivity will be performed similarly to first one. After a week of second session, only the shade will be evaluated.
Blinding Once that it is not possible to blind the operators responsible by bleaching procedures and the participants, only the operators responsible by evaluations and by statistical analysis will be blinded.
Analysis of data The average of scores corresponding to shade guides will be calculated for each participant in the three moments of evaluation. Data will be submitted to Friedman and Man-Whitney tests. The average of ∆E will be calculated for each participant in the two moments of re-evaluation, while the data will be submitted to two-way ANOVA (protocol x moment of evaluation). Data for tooth sensitivity scores will be submitted to Friedman and Man-Whitney tests. The multiple-comparison test of Tukey will be used when necessary. The number of participants presenting any sensitivity during each session of bleaching will be calculated, while the percentage of these participants for each protocol will be calculated using Chi-square test. All statistical analysis will be performed with significant level of 5%.
- Conditions
- Tooth Discoloration
- Being tested
- Tooth bleaching
- Keywords
- Tooth Discoloration, Bleaching Agents, Tooth Bleaching
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth bleachingDrug
Also called 35% hydrogen peroxide based bleaching agent, Whiteness HP Maxx, FGM, Joinville, SC, Brazil.
The bleaching agent will be used in a single-application of 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sealed bleaching Protocol | Experimental | The 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide. However, a customized tray will be placed over the bleaching agent during entire permanence of peroxide (45 minutes). Receives: Drug: Tooth bleaching |
| Conventional Bleaching Protocol | Active comparator | The 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide. Receives: Drug: Tooth bleaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth sensitivity
The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. VAS consisted of a 10-cm color scale from green (no sensitivity) to red (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to: 0 - until 2-cm; 1 - between 2.1 and 4-cm; 2 - between 4.1 and 6-cm; 3 - between 6.1 and 8-cm; 4 - between 8.1 and 10-cm. For verbal scale, the patient will relate her/his level of sensitivity in a scale from 0 to 4, while 0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe. Participants presenting score different from 0 for any scale in this evaluation time will be excluded.
Measured: During the bleaching procedure
Secondary outcomes (1)
Bleaching Effectiveness
The color evaluation will be performed using CIE L*a*b* color system, classical Vita guide and Vita bleachguide. For the CIE L*a*b* and classical vita guide, the shade will be determined using a spectrophotometer (Easy Shade Compact, Vita-Zahnfabrik, Bad Säckinge, Germany). The spectrophotometer also will inform the shade in classical Vita guide. The shades of this guide will be arranged in scores from highest (B1) to lowest (C4) values. Two calibrated examiners will evaluate the shade of teeth using the Vita Bleachguide. For calibration purposes, the teeth shades of five participants (whom will be did not include in the sample) will be evaluated individually by each examiner. A level of agreement higher than 80% must be reached before to begin the study evaluation. During the study, if disagreements arose, they will reach a consensus before dismissing the patient. For this guide, the shades also will be arranged in scores from highest (0M1) to lowest (5M3) values.
Measured: Before the bleaching procedures and 7 days after this.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sergipe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Luis Faria e Silva, Universidade Federal de Sergipe
- Investigators
- Andre L Faria-e-Silva, PhD, Study chair, Universidade Federal de Sergipe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067715
- Sponsor's protocol ID
- UFS001
- Status last verified
- May 2015
- First submitted
- 15 Feb 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent. 2011 Nov-Dec;36(6):590-6. doi: 10.2341/10-173-C. Epub 2011 Sep 13.
PubMed 21913864Kwon SR, Wertz PW, Dawson DV, Cobb DS, Denehy G. The relationship of hydrogen peroxide exposure protocol to bleaching efficacy. Oper Dent. 2013 Mar-Apr;38(2):177-85. doi: 10.2341/11-351-L. Epub 2012 Jul 7.
PubMed 22770431
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sealed In-office Bleaching Technique: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02067715
- Acronym / sponsor ID
- UFS001
- Conditions
- Tooth Discoloration
- Keywords
- Tooth Discoloration, Bleaching Agents, Tooth Bleaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidade Federal de SergipeUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Feb 2014 (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.
Thus, the aim of this study is to evaluate the sealed bleaching technique on tooth sensitivity and bleaching efficacy. The hypothesis is that the sealed bleaching technique reduce the tooth sensitivity when compared to conventional technique, without alters the bleaching efficacy.
Detailed description
This is a randomized, single-blind, and controlled trial with a parallel group and an equal allocation rate to receive either one of two treatments, whereas the sealed technique is the experimental intervention and the conventional technique is control one.
PICO Question:
P (Population) - Patients of dentistry service of Federal University of Sergipe.
I: (Intervention) - In-office bleaching using 35% hydrogen peroxide bleaching agent covered with a customized tray.
C: (Control) - In-office bleaching using 35% hydrogen peroxide bleaching agent covered without a customized tray.
O: (Outcomes) - Primary outcomes: presence of tooth sensitivity during the bleaching procedure; Secondary outcome: Bleaching efficacy.
Sample Patients attempted in clinical service of Federal University of Sergipe requiring tooth bleaching will be recruited for this trial. For sample size calculation was considered 80% of test power, significance level of 5%, the presence of tooth sensitivity of 90% at control intervention and 40% at experimental intervention. These levels of sensitivity were based in pilot study. Thus the sample size for a proportions test (SigmaStat 3.5 (Systat Software, Point Richmond, USA) was 17 participants for each intervention.
Randomization Previously to beginning of study, a blocked randomisation list will be created using the website www.sealedenvelope.com, using block size of 4, by an operator different from those who will be perform the bleaching procedures. The bleaching protocol for each participant will be placed into a sealed envelope, while this only will be opened in the moment of bleaching procedure.
Evaluations During the permanence of bleaching agent, the tooth sensitivity will be monitored and the scores (VAS and verbal scale) will be recorded at 20th and 40th minute. The score also will be recorded immediately after the bleaching agent removal. In the after day, the participants will be argued (only verbal scale) about the maximum level of sensitivity during the first 24 hours after bleaching procedure and in 24th hour after this. A week after the bleaching procedure, the scores based on shade guides will be recorded again. For CIE L*a*b* measurement, ΔE will be calculated by the following equation: ∆E= [(∆L)2 + (∆a)2 + (∆b)2]1/2, while ∆L = L1 - L0; ∆a = a1 - a0; e ∆b = b1 - b0. After the shade evaluation, a new bleaching procedure, using the same protocol, will be performed in this second appointment and the same measurements of tooth sensitivity will be performed similarly to first one. After a week of second session, only the shade will be evaluated.
Blinding Once that it is not possible to blind the operators responsible by bleaching procedures and the participants, only the operators responsible by evaluations and by statistical analysis will be blinded.
Analysis of data The average of scores corresponding to shade guides will be calculated for each participant in the three moments of evaluation. Data will be submitted to Friedman and Man-Whitney tests. The average of ∆E will be calculated for each participant in the two moments of re-evaluation, while the data will be submitted to two-way ANOVA (protocol x moment of evaluation). Data for tooth sensitivity scores will be submitted to Friedman and Man-Whitney tests. The multiple-comparison test of Tukey will be used when necessary. The number of participants presenting any sensitivity during each session of bleaching will be calculated, while the percentage of these participants for each protocol will be calculated using Chi-square test. All statistical analysis will be performed with significant level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sealed bleaching Protocol | Experimental | Drug: Tooth bleachingThe 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide. However, a customized tray will be placed over the bleaching agent during entire permanence of peroxide (45 minutes). |
| Conventional Bleaching Protocol | Active comparator | Drug: Tooth bleachingThe 35% hydrogen peroxide gel will be mixed and applied over the buccal surfaces of teeth. The bleaching agent will remain for 45-min application without replacement of peroxide. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least 18 years old patients of both genders presenting good general/oral health;
- All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Alemanha)
- Signed the form accepting to participate of this study.
Key exclusion criteria (10 listed)
- Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
- Undergone tooth-whitening procedures;
- Pregnant/lactating;
- Smokers;
- Presence of periodontal diseases;
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 |
|---|---|---|
| Tooth bleachingAlso: 35% hydrogen peroxide based bleaching agent, Whiteness HP Maxx, FGM, Joinville, SC, Brazil.The bleaching agent will be used in a single-application of 45 minutes. | Drug | Conventional Bleaching Protocol, Sealed bleaching Protocol |
Primary outcome
Tooth sensitivity
Time frame: During the bleaching procedure
The tooth sensitivity will be assessed using a Visual analogue (VAS) and verbal scales. VAS consisted of a 10-cm color scale from green (no sensitivity) to red (unbearable sensitivity). A slightly air-stream will be applied over the buccal surfaces of the central incisors, and the patients will record their sensitivity perception by pointing with a pen on the scale. The distance between the marking and the border of scale, relative to the absence of sensitivity will be measured. The measurements will be scored according to: 0 - until 2-cm; 1 - between 2.1 and 4-cm; 2 - between 4.1 and 6-cm; 3 - between 6.1 and 8-cm; 4 - between 8.1 and 10-cm. For verbal scale, the patient will relate her/his level of sensitivity in a scale from 0 to 4, while 0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe. Participants presenting score different from 0 for any scale in this evaluation time will be excluded.
1 secondary outcome
Bleaching Effectiveness
Time frame: Before the bleaching procedures and 7 days after this.
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 1 Jun 2015.
- Background: PubMed 21913864Reis A, Tay LY, Herrera DR, Kossatz S, Loguercio AD. Clinical effects of prolonged application time of an in-office bleaching gel. Oper Dent. 2011 Nov-Dec;36(6):590-6. doi: 10.2341/10-173-C. Epub 2011 Sep 13.
- Background: PubMed 22770431Kwon SR, Wertz PW, Dawson DV, Cobb DS, Denehy G. The relationship of hydrogen peroxide exposure protocol to bleaching efficacy. Oper Dent. 2013 Mar-Apr;38(2):177-85. doi: 10.2341/11-351-L. Epub 2012 Jul 7.
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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.
Andre L Faria-e-Silva, PhD study chair
Universidade Federal de Sergipe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth bleaching in people with Tooth Discoloration, run by Universidade Federal de Sergipe 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 3 inclusion and 10 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 1 Jun 2015. 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.
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 sensitivity (time frame: During the bleaching procedure). 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 NCT02067715, 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 1 Jun 2015.