Tooth BleachingPhase 4NCT03089216
Combined Bleaching Technique: Efficacy and Tooth Sensitivity
A Phase 4 study testing Combined Bleaching(2x20), Combined Bleaching(2x20) with arginine and Combined Bleaching (1x20) in people with Tooth Bleaching and Tooth Sensitivity, run by Terezinha de Jesus Esteves Barata.
Trial summary
The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Bleaching, Tooth Sensitivity
- What is being tested?
- Combined Bleaching(2x20), Combined Bleaching(2x20) with arginine and Combined Bleaching (1x20)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Upper and lower anterior teeth without restorations;
- Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).
Who cannot join
- Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
- Presence of non-carious lesions, such as abfraction, erosion and abrasion;
- Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
- Use of fixed orthodontic appliances;
- Presence of tooth sensitivity classified as equal to or greater than mild;
- Presence of severe dental dimming;
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- Presence of parafunctional habits;
- Presence of any oral pathology;
- Smokers;
- pregnant and lactating women
About this study
Official title: Combined Bleaching Technique: Efficacy and Tooth Sensitivity - A Randomized, Double Blind Clinical Trial
The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).
Read the detailed description
This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .
After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.
- Conditions
- Tooth Bleaching, Tooth Sensitivity
- Being tested
- Combined Bleaching(2x20), Combined Bleaching(2x20) with arginine, Combined Bleaching (1x20), Combined Bleaching(1x20) with arginine, 8% arginine and calcium carbonate
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Bleaching(2x20)Procedure or surgery
one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
Combined Bleaching(2x20) with arginineProcedure or surgery
one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
Combined Bleaching (1x20)Procedure or surgery
one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
Combined Bleaching(1x20) with arginineProcedure or surgery
one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
8% arginine and calcium carbonateDrug
Also called dentifrice containing carbonate arginine
using during all the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Combined Bleaching(2x20) | Experimental | In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Receives: Procedure: Combined Bleaching(2x20) |
| Combined Bleaching(2x20) with arginine | Experimental | Combined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. Receives: Procedure: Combined Bleaching(2x20) with arginine; Drug: 8% arginine and calcium carbonate |
| Combined Bleaching(1x20) | Experimental | In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Receives: Procedure: Combined Bleaching (1x20) |
| Combined Bleaching(1x20) with arginine | Experimental | Combined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. Receives: Procedure: Combined Bleaching(1x20) with arginine; Drug: 8% arginine and calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth Sensitivity (TS)
Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)).
Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median.
Measured: during bleaching, and up to 48 hours postbleaching
Secondary outcomes (1)
Color Evaluation
Objective color evaluation:
The shade was determined using spectrophotometer VITA Easyshade, in which the parameters L*, a*, and b*, in which L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis.
The color alteration (ΔE) was determined by the differences between the values obtained at baseline and one month after the treatment, which was calculated with the formula: ΔE = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2]1/2.
In the Outcome Measure Data Table it was presented Mean and Standard Deviation of the color alteration (ΔE) between Baseline vs one month after bleaching for each group.
Measured: The evaluations were performed in the baseline period and one month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Apr 2016
- Primary completion30 Nov 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terezinha de Jesus Esteves Barata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terezinha de Jesus Esteves Barata, Universidade Federal de Goias
- Investigators
- Isabella N Favarão, DDS, MS, Principal investigator, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089216
- Sponsor's protocol ID
- 043178
- Status last verified
- Jun 2019
- First submitted
- 17 Mar 2017
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Bleaching Technique: Efficacy and Tooth Sensitivity - A Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03089216
- Acronym / sponsor ID
- 043178
- Conditions
- Tooth Bleaching, Tooth Sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Terezinha de Jesus Esteves BarataUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical study is to evaluate the efficacy and dental sensitivity associated with Combined Bleaching Technique (in-office + at-home) varying in-office bleaching application under two different time protocols, and dentifrice containing arginine 8% and carbonate calcium use. One hundred eight participants who meet the study inclusion criteria will be selected. The desensitizing agent used will be a dentifrice containing 8% arginine and calcium carbonate. In each evaluation will be determined: tooth sensitivity and color. The data collected will be submitted to the factorial statistical analysis for evaluation of color and chi-square test for tooth sensitivity (α = 5%).
Detailed description
This study will be conducted under the CONSORT recommendations. After approval by the Ethics Committee for Research duly registered, the trial will be conducted in the clinic of dental school at the Federal University of Goias located in Goiania. One hundred eight participants 108 volunteers will be selected on the criteria that qualify inclusion and exclusion from the study will be reported all volunteers were examined not qualify under the criteria for inclusion as part of the initial according to CONSORT recommendations .
After signing the signed an informed consent form all volunteer participants will receive a dental prophylaxis with pumice and water in a rubber cups for the removal of extrinsic stains two weeks before the beginning of tooth whitening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined Bleaching(2x20) | Experimental | Procedure: Combined Bleaching(2x20)In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide |
| Combined Bleaching(2x20) with arginine | Experimental | Procedure: Combined Bleaching(2x20) with arginine, Drug: 8% arginine and calcium carbonateCombined Bleaching(2x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. |
| Combined Bleaching(1x20) | Experimental | Procedure: Combined Bleaching (1x20)In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide |
| Combined Bleaching(1x20) with arginine | Experimental | Procedure: Combined Bleaching(1x20) with arginine, Drug: 8% arginine and calcium carbonateCombined Bleaching(1x20) with arginine In-office: 35% hydrogen peroxide of 20 minutes each. At-home: 10% carbamide peroxide Desensitizing agent: dentifrice containing 8% arginine and calcium carbonate. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Upper and lower anterior teeth without restorations;
- Upper and lower anterior teeth that have never undergone a bleaching procedure and are A2 or darker in color compared to the Vita Classical).
Key exclusion criteria (10 listed)
- Presence of primary and/or secondary carious lesion (s) on upper and lower anterior teeth;
- Presence of non-carious lesions, such as abfraction, erosion and abrasion;
- Presence of clinically visible cracks or defects of dental enamel on the dental surfaces of the upper and lower anterior teeth;
- Use of fixed orthodontic appliances;
- Presence of tooth sensitivity classified as equal to or greater than mild;
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 |
|---|---|---|
| Combined Bleaching(2x20)one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. | Procedure or surgery | Combined Bleaching(2x20) |
| Combined Bleaching(2x20) with arginineone clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. | Procedure or surgery | Combined Bleaching(2x20) with arginine |
| Combined Bleaching (1x20)one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. | Procedure or surgery | Combined Bleaching(1x20) |
| Combined Bleaching(1x20) with arginineone clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks. | Procedure or surgery | Combined Bleaching(1x20) with arginine |
| 8% arginine and calcium carbonateAlso: dentifrice containing carbonate arginineusing during all the treatment. | Drug | Combined Bleaching(1x20) with arginine, Combined Bleaching(2x20) with arginine |
Primary outcome
Tooth Sensitivity (TS)
Time frame: during bleaching, and up to 48 hours postbleaching
Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to "no pain" (minimum value) and 10 referred to "severe pain" (maximum value)). Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median.
1 secondary outcome
Color Evaluation
Time frame: The evaluations were performed in the baseline period and one month after the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Isabella N Favarão, DDS, MS principal investigator
Universidade Federal de Goias
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined Bleaching(2x20), Combined Bleaching(2x20) with arginine and Combined Bleaching (1x20) in people with Tooth Bleaching and Tooth Sensitivity, run by Terezinha de Jesus Esteves Barata.
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 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 5 Aug 2019. 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. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (TS) (time frame: during bleaching, and up to 48 hours postbleaching). 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 5 Aug 2019.