Tooth WhiteningPhase 4NCT03019224
Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening
A Phase 4 study testing Selection and preparation of the volunteers, Evaluation of the tooth color and Relative isolation in people with Tooth Whitening and Sensitivity, run by University of Campinas, Brazil.
Trial summary
Introduction: The pain sensitivity associated with whitening is the main problem reported by patients during dental whitening, and the use of desensitizing dentifrices is an alternative for the treatment of sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Whitening, Sensitivity
- What is being tested?
- Selection and preparation of the volunteers, Evaluation of the tooth color and Relative isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Aug 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age of 18 years or older
- good oral and general health
- hygid anterior tooth with color shade higher than A2 on the Vita Classic scale (VITA Zahnfabrink, Bad Säckingen, Germany).
Who cannot join
- smoking, pregnancy or breastfeeding
- previous dental whitening
- para-functional habits
- dentin sensitivity
- anterior tooth with restorations and carious lesions
- non-vital discoloration
- unsatisfactory restorations
About this study
Official title: Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening: Double Blind Controlled Clinical Study
Introduction: The pain sensitivity associated with whitening is the main problem reported by patients during dental whitening, and the use of desensitizing dentifrices is an alternative for the treatment of sensitivity.
Objective: To evaluate clinically the influence of desensitizing dentifrices applied through a plastic tray, reducing the pain sensitivity and color variation caused by the technique of in-office dental whitening, through a controlled double-blind clinical study.
Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30 years of age, without gender distinction, who underwent in-office dental whitening using 35% hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions with a one-week interval between them. The volunteers used in the night for each bleaching session a plastic tray for 4 hours containing one of the dentifrices related to the experimental groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy); Group 2 (Active control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever); Group 3 - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium nitrate (NP) and sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel, GlaxoSmithKline). The evaluation of the sensitivity associated with the times of use of the plastic tray in the first session (S1: sensitivity before the tray, S2: sensitivity after the tray), in the second session (S3: sensitivity before the tray, S4: in the third session (S5: sensitivity before the tray, S6: sensitivity after the tray) used the analog numerical scale with scores from 0 to 10 and for the color evaluation the spectrophotometer (Easyshade, Vident, Brea, CA, Obtaining the data that were used in the CIELab system. The data were submitted to the multivariate analysis of variance (MANOVA) with repeated measurements and Lambda Wilks test with a 5% probability level to differentiate the groups. In addition, the factorial variance analysis (ANOVA) in one criterion was applied. Values of p <0.05 were considered statistically significant.
- Conditions
- Tooth Whitening, Sensitivity
- Being tested
- Selection and preparation of the volunteers, Evaluation of the tooth color, Relative isolation, Gingival protection barrier, Application of desensitizing gel
- Keywords
- Tooth whitening, Dentifrice, Sensitivity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selection and preparation of the volunteersProcedure or surgery
Patients who sought the postgraduate dental clinic for whitening were invited to participate in the study. They were informed by the researcher (dentist) about all the aspects of the study and who might participate or discontinue the participation at any moment during the treatment. In addition, it was clarified that their participation was voluntary and refusal to participate would not result in any penalty or loss of benefits.
Evaluation of the tooth colorProcedure or surgery
The evaluation of the tooth color was performed by using a spectrophotometer (Easyshade, Vident, Brea, CA, USA). The color was analysed with the tooth hydrated before of the start the first whitening session and one week after.
The spectrophotometer was always used in the same position by a silicon guide, which was prepared with dental arch molds by adding high viscosity vinyl polysiloxane material (Express XT, 3M ESPE, Sumaré, SP, Brazil). After polymerization, an opening was made in the mold corresponding to the buccal surface of the upper central incisors, allowing the color of the tooth to be evaluated with the tip of the spectrophotometer at the height of the middle third.
Relative isolationProcedure or surgery
The clinical procedures were performed under relative isolation using lip retractor (Arcflex, FGM, Joinville, SC, Brazil) and dental cotton rollers to apply a gingival protection barrier (Top Dam, FGM, Joinville, SC, Brazil) extending from right first molar to left first molar in both arches.
Gingival protection barrierProcedure or surgery
The gingival protection barrier was placed over the margins and gingival papilla corresponding to the areas receiving the whitening gel with approximately 3 mm in height and photopolymerized for 20 seconds in each group of three tooth. Photo-activation was performed with high power LEDs (light intensity = 600mw / cm²) (RadiiCal, São Paulo, SP, Brazil).
Application of desensitizing gelProcedure or surgery
The desensitizing gel containing 5% potassium nitrate associated with 2% sodium fluoride (Desensibilize KF 2%, FGM, Joinville, SC, Brazil) was applied with a microbrush (Brush KG, KG Sorensen, Cotia, SP) on the buccal surface from right first molar to left first molar in both arches and remaining for 10 minutes. Then, the desensitizer was then removed with water jet and disposable plastic suction cannula.
Hydrogen peroxideDrug
The handling of 35% hydrogen peroxide (Whiteness HP, FGM, Joinville, SC, Brazil) followed the manufacturer's recommendations, which consisted of mixing 3 drops of 35%hydrogen peroxide for 1 drop of thickener, with this mixture being sufficient for application to at least three tooth. The gel remained in contact with the buccal surface of the tooth for 15 minutes and was removed with disposable plastic suction cannula and water wash. This procedure was performed three times per clinical session. The volunteers underwent three whitening clinical sessions with one week interval between them.
Used a dentifriceProcedure or surgery
Among the clinical whitening sessions, each volunteer used an unidentified dentifrice corresponding to their experimental group, which was previously defined by means of a draw made by a dentist who did not participate in the study. Thus, the researcher (dentist) who provided the dentifrice and the volunteer were not aware of which experimental group belonged (i.e. double blind).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray. Receives: Procedure: Selection and preparation of the volunteers; Procedure: Evaluation of the tooth color; Procedure: Relative isolation; Procedure: Gingival protection barrier; Procedure: Application of desensitizing gel; Drug: Hydrogen peroxide; Procedure: Used a dentifrice |
| Group 2 | Experimental | The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray. Receives: Procedure: Selection and preparation of the volunteers; Procedure: Evaluation of the tooth color; Procedure: Relative isolation; Procedure: Gingival protection barrier; Procedure: Application of desensitizing gel; Drug: Hydrogen peroxide; Procedure: Used a dentifrice |
| Group 3 | Experimental | The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray. Receives: Procedure: Selection and preparation of the volunteers; Procedure: Evaluation of the tooth color; Procedure: Relative isolation; Procedure: Gingival protection barrier; Procedure: Application of desensitizing gel; Drug: Hydrogen peroxide; Procedure: Used a dentifrice |
| Group 4 | Experimental | The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray. Receives: Procedure: Selection and preparation of the volunteers; Procedure: Evaluation of the tooth color; Procedure: Relative isolation; Procedure: Gingival protection barrier; Procedure: Application of desensitizing gel; Drug: Hydrogen peroxide; Procedure: Used a dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The analysis of the reduction of sensitivity using the toothpaste during whitening.
For sensitivity analysis was used the numerical analogue scale with scores ranging from 0 to 10.
Measured: Through study completion up to 4 weeks placement of the tray.
The evaluation of the tooth color using the toothpaste during whitening.
For evaluation of the tooth color was performed by using a spectrophotometer. (Easyshade, Vident, Brea, CA, USA). The color was determined by EasyShade device.
Measured: Through study completion up to 4 weeks placement of the tray.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WhiteningStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josué Junior Araujo Pierote, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019224
- Sponsor's protocol ID
- 104/2015
- Status last verified
- Jan 2016
- First submitted
- 19 Dec 2016
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening: Double Blind Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03019224
- Acronym / sponsor ID
- 104/2015
- Conditions
- Tooth Whitening, Sensitivity
- Keywords
- Tooth whitening, Dentifrice, Sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Jan 2017 (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.
Introduction: The pain sensitivity associated with whitening is the main problem reported by patients during dental whitening, and the use of desensitizing dentifrices is an alternative for the treatment of sensitivity.
Objective: To evaluate clinically the influence of desensitizing dentifrices applied through a plastic tray, reducing the pain sensitivity and color variation caused by the technique of in-office dental whitening, through a controlled double-blind clinical study.
Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30 years of age, without gender distinction, who underwent in-office dental whitening using 35% hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions with a one-week interval between them. The volunteers used in the night for each bleaching session a plastic tray for 4 hours containing one of the dentifrices related to the experimental groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy); Group 2 (Active control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever); Group 3 - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium nitrate (NP) and sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel, GlaxoSmithKline). The evaluation of the sensitivity associated with the times of use of the plastic tray in the first session (S1: sensitivity before the tray, S2: sensitivity after the tray), in the second session (S3: sensitivity before the tray, S4: in the third session (S5: sensitivity before the tray, S6: sensitivity after the tray) used the analog numerical scale with scores from 0 to 10 and for the color evaluation the spectrophotometer (Easyshade, Vident, Brea, CA, Obtaining the data that were used in the CIELab system. The data were submitted to the multivariate analysis of variance (MANOVA) with repeated measurements and Lambda Wilks test with a 5% probability level to differentiate the groups. In addition, the factorial variance analysis (ANOVA) in one criterion was applied. Values of p <0.05 were considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Procedure: Selection and preparation of the volunteers, Procedure: Evaluation of the tooth color, Procedure: Relative isolation, Procedure: Gingival protection barrier, Procedure: Application of desensitizing gel, Drug: Hydrogen peroxide, Procedure: Used a dentifriceThe use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray. |
| Group 2 | Experimental | Procedure: Selection and preparation of the volunteers, Procedure: Evaluation of the tooth color, Procedure: Relative isolation, Procedure: Gingival protection barrier, Procedure: Application of desensitizing gel, Drug: Hydrogen peroxide, Procedure: Used a dentifriceThe use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray. |
| Group 3 | Experimental | Procedure: Selection and preparation of the volunteers, Procedure: Evaluation of the tooth color, Procedure: Relative isolation, Procedure: Gingival protection barrier, Procedure: Application of desensitizing gel, Drug: Hydrogen peroxide, Procedure: Used a dentifriceThe use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray. |
| Group 4 | Experimental | Procedure: Selection and preparation of the volunteers, Procedure: Evaluation of the tooth color, Procedure: Relative isolation, Procedure: Gingival protection barrier, Procedure: Application of desensitizing gel, Drug: Hydrogen peroxide, Procedure: Used a dentifriceThe use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age of 18 years or older
- good oral and general health
- hygid anterior tooth with color shade higher than A2 on the Vita Classic scale (VITA Zahnfabrink, Bad Säckingen, Germany).
Key exclusion criteria (7 listed)
- smoking, pregnancy or breastfeeding
- previous dental whitening
- para-functional habits
- dentin sensitivity
- anterior tooth with restorations and carious lesions
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 |
|---|---|---|
| Selection and preparation of the volunteersPatients who sought the postgraduate dental clinic for whitening were invited to participate in the study. They were informed by the researcher (dentist) about all the aspects of the study and who might participate or discontinue the participation at any moment during the treatment. In addition, it was clarified that their participation was voluntary and refusal to participate would not result in any penalty or loss of benefits. | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
| Evaluation of the tooth colorThe evaluation of the tooth color was performed by using a spectrophotometer (Easyshade, Vident, Brea, CA, USA). The color was analysed with the tooth hydrated before of the start the first whitening session and one week after. The spectrophotometer was always used in the same position by a silicon guide, which was prepared with dental arch molds by adding high viscosity vinyl polysiloxane material (Express XT, 3M ESPE, Sumaré, SP, Brazil). After polymerization, an opening was made in the mold corresponding to the buccal surface of the upper central incisors, allowing the color of the tooth to be evaluated with the tip of the spectrophotometer at the height of the middle third. | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
| Relative isolationThe clinical procedures were performed under relative isolation using lip retractor (Arcflex, FGM, Joinville, SC, Brazil) and dental cotton rollers to apply a gingival protection barrier (Top Dam, FGM, Joinville, SC, Brazil) extending from right first molar to left first molar in both arches. | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
| Gingival protection barrierThe gingival protection barrier was placed over the margins and gingival papilla corresponding to the areas receiving the whitening gel with approximately 3 mm in height and photopolymerized for 20 seconds in each group of three tooth. Photo-activation was performed with high power LEDs (light intensity = 600mw / cm²) (RadiiCal, São Paulo, SP, Brazil). | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
| Application of desensitizing gelThe desensitizing gel containing 5% potassium nitrate associated with 2% sodium fluoride (Desensibilize KF 2%, FGM, Joinville, SC, Brazil) was applied with a microbrush (Brush KG, KG Sorensen, Cotia, SP) on the buccal surface from right first molar to left first molar in both arches and remaining for 10 minutes. Then, the desensitizer was then removed with water jet and disposable plastic suction cannula. | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
| Hydrogen peroxideThe handling of 35% hydrogen peroxide (Whiteness HP, FGM, Joinville, SC, Brazil) followed the manufacturer's recommendations, which consisted of mixing 3 drops of 35%hydrogen peroxide for 1 drop of thickener, with this mixture being sufficient for application to at least three tooth. The gel remained in contact with the buccal surface of the tooth for 15 minutes and was removed with disposable plastic suction cannula and water wash. This procedure was performed three times per clinical session. The volunteers underwent three whitening clinical sessions with one week interval between them. | Drug | Group 1, Group 2, Group 3, Group 4 |
| Used a dentifriceAmong the clinical whitening sessions, each volunteer used an unidentified dentifrice corresponding to their experimental group, which was previously defined by means of a draw made by a dentist who did not participate in the study. Thus, the researcher (dentist) who provided the dentifrice and the volunteer were not aware of which experimental group belonged (i.e. double blind). | Procedure or surgery | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
The analysis of the reduction of sensitivity using the toothpaste during whitening.
Time frame: Through study completion up to 4 weeks placement of the tray.
For sensitivity analysis was used the numerical analogue scale with scores ranging from 0 to 10.
The evaluation of the tooth color using the toothpaste during whitening.
Time frame: Through study completion up to 4 weeks placement of the tray.
For evaluation of the tooth color was performed by using a spectrophotometer. (Easyshade, Vident, Brea, CA, USA). The color was determined by EasyShade device.
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 12 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selection and preparation of the volunteers, Evaluation of the tooth color and Relative isolation in people with Tooth Whitening and Sensitivity, run by University of Campinas, 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 7 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 12 Jan 2017. 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?
The analysis of the reduction of sensitivity using the toothpaste during whitening. (time frame: Through study completion up to 4 weeks placement of the tray.). The study lists 2 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 12 Jan 2017.