Dentin HypersensitivityPhase 4NCT02316080
The Effect of Desensitizing Agents in In-home or In-office Dental Bleaching
A Phase 4 study testing Dental bleaching and Desensitizing therapy in people with Dentin Hypersensitivity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with 7,5% of Biosilicate micro-particles (D2); Odontis RX®… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Dental bleaching and Desensitizing therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Jun 2013
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients male or females, aged between 18 and 40 years.
- Smokers and nonsmokers.
- Patients with good general health.
- Patients with good oral health (no changes in hard or soft tissues).
- Have a minimum of 24 permanent teeth present and no restorations on anterior teeth.
Who cannot join
- Patients with a medical history marked by chronic use of analgesics, anti-inflammatory and psychotropic drugs.
- Patients with braces or prostheses or restorations on anterior teeth.
- Patients with periodontal disease or poor oral hygiene.
- Patients with prior tooth sensitivity or have made use of desensitizing agents in the last three months.
- Patients who are pregnant or nursing.
- Patients with eating disorders or dieting too acidic.
- Systemic conditions that predispose to tooth sensitivity.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo -Ribeirao Preto Campus
Ribeirão Preto, São Paulo, 14040904
About this study
Official title: Evaluating Remineralizers and Desensitizers Agents in Dental Bleaching Treatment: in Vitro and in Vivo Study
The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with 7,5% of Biosilicate micro-particles (D2); Odontis RX® dentifrice (D3); Sorriso® dentifrice (D4); Biosilicate micro-particles paste, 1:1 (D5), Desensebilize Nano P (D6), bioglass type 45S5 paste, 1:1 (D7); GC= distilled water, in the experimental groups: T1/D1; T1/D2; T1/D3; T1/D4; T1/D5; T1/D6; T1/D7; T1/GC e T2/D1; T2/D2; T2/D3; T2/D4; T2/D5; T2/D6; T2/D7; T2/GC. In the in vitro study, microhardness and roughness measurements, and images using scanning electron microscopy (SEM) will be made on samples of bovine dental enamel and dentin (4x4x3mm; n=10 per group) before and after the treatment with the bleaching gels (T1= 14 days/ 04 hours/day; T2=single session) and the desensitizers/remineralizer agents. In the clinical study, the volunteers (n=10 per group) will be evaluated regarding dentin hypersensitivity (DH), using visual analogue scale, before the beginning of the treatments (T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days) in which the desensitizers/remineralizer agents (there´s no control group in the clinical experiments) will be applying. Data will be analysed intra and inter-group, statistically.
Read the detailed description
Background. Tooth sensitivity (TS) is a common side effect of tooth bleaching. The authors conducted a study to evaluate the efficiency of experimental desensitizing agents in reducing TS caused by bleaching agents.
Methods. To test experimental desensitizing agents in TS caused by dental bleaching the authors selected 113 participants without TS and randomly treated them with T1-16% carbamide peroxide (14 days) or T2-35% hydrogen peroxide (single session). The period of the study was 14 days. Participants (in T1 and T2) used domestic-use (DU) or in office (IO) desensitizers (D): Control Group; (DU)- experimental dentifrice with 7,5% of Biosilicate micro-particles-(D1); Sensodyne® dentifrice-(D2); (DU)-Odontis RX Sensiblock® dentifrice-(D3); (IO)-Biosilicate micro-particles paste, 1:1-(D4); (IO)-bioglass type 45S5 paste, 1:1 (D6); (IO)-Desensebilize Nano P-(D6). On days 1, 3, 7, 10 and 14, the authors received the participants to apply IO desensitizers and to record TS with Visual Analogue Scale (VAS). Data was analyzed with two-way ANOVA (considering time and desensitizing as factors) and post-hoc Bonferroni test (α=0.05).
Results. The use of experimental desensitizing agents G2 and G5 did not cause significantly difference in TS comparing to baseline. TS was not significantly different when G2 was used after 16% carbamide peroxide and G5 after 35% hydrogen peroxide application. Self-perception TS values were significantly (p<0.001) higher than recorded VAS.
Conclusions. Experimental desensitizing agents containing Biosilicate® can prevent TS caused by bleaching agents: in dentifrice form when associated to 16% carbamide peroxide and in paste, when 35% hydrogen peroxide is used.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Dental bleaching, Desensitizing therapy
- Keywords
- dental bleaching, dentin sensitivity, biomaterials
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental bleachingOther
Also called Whitness Perfect®, Whitness HP®
Home-use or in-office dental bleaching was performed in patients that received different types od desensitizing therapy
Desensitizing therapyOther
Also called Dentifrice of Biosilicate, Sensodyne® dentifrice, Odontis RX Sensiblock, Biosilicate micro-particles paste, 1:1
Participants (in T1 and T2) used domestic-use (DU) or in office (IO) desensitizers (D): Control Group; (DU)- experimental dentifrice with 7,5% of Biosilicate micro-particles-(D1); Sensodyne® dentifrice-(D2); (DU)-Odontis RX Sensiblock® dentifrice-(D3); (IO)-Biosilicate micro-particles paste, 1:1-(D4); (IO)-bioglass type 45S5 paste, 1:1 (D6); (IO)-Desensebilize Nano P-(D6).
| Study group | Role | What they receive |
|---|---|---|
| Desensitizing therapy | Experimental | 14 groups (7 treated with in-office dental bleaching and 7 treated with home-use dental bleaching) . There will be 7 different types of dessensitizing agents that will be used together with the dental bleaching treatment Receives: Other: Dental bleaching |
| Dental Bleaching | Experimental | 2 groups of dental bleaching treatment - 16% carbamide peroxide and 35% peroxide Receives: Other: Desensitizing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Measured: Baseline
Secondary outcomes (5)
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Measured: Day 1
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Measured: Day 3
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Measured: Day 7
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Measured: Day 10
Dentin hypersensitivity
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startJul 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Responsible party
- Principal investigator, Camila Tirapelli, University of Sao Paulo
- Investigators
- Camila Tirapelli, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316080
- Sponsor's protocol ID
- Fapesp 2010120326
- Status last verified
- Dec 2014
- First submitted
- 21 Sep 2011
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Remineralizers and Desensitizers Agents in Dental Bleaching Treatment: in Vitro and in Vivo Study
- ClinicalTrials.gov ID
- NCT02316080
- Acronym / sponsor ID
- Fapesp 2010120326
- Conditions
- Dentin Hypersensitivity
- Keywords
- dental bleaching, dentin sensitivity, biomaterials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Dec 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.
The aim of this project is to evaluate in vitro and in vivo the effect of dental bleaching agents, carbamide peroxide 16% (T1) and hydrogen peroxide 35% (T2) together with desensitizers/remineralizer agents, Sensodyne® dentifrice (D1); experimental dentifrice with 7,5% of Biosilicate micro-particles (D2); Odontis RX® dentifrice (D3); Sorriso® dentifrice (D4); Biosilicate micro-particles paste, 1:1 (D5), Desensebilize Nano P (D6), bioglass type 45S5 paste, 1:1 (D7); GC= distilled water, in the experimental groups: T1/D1; T1/D2; T1/D3; T1/D4; T1/D5; T1/D6; T1/D7; T1/GC e T2/D1; T2/D2; T2/D3; T2/D4; T2/D5; T2/D6; T2/D7; T2/GC. In the in vitro study, microhardness and roughness measurements, and images using scanning electron microscopy (SEM) will be made on samples of bovine dental enamel and dentin (4x4x3mm; n=10 per group) before and after the treatment with the bleaching gels (T1= 14 days/ 04 hours/day; T2=single session) and the desensitizers/remineralizer agents. In the clinical study, the volunteers (n=10 per group) will be evaluated regarding dentin hypersensitivity (DH), using visual analogue scale, before the beginning of the treatments (T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days) in which the desensitizers/remineralizer agents (there´s no control group in the clinical experiments) will be applying. Data will be analysed intra and inter-group, statistically.
Detailed description
Background. Tooth sensitivity (TS) is a common side effect of tooth bleaching. The authors conducted a study to evaluate the efficiency of experimental desensitizing agents in reducing TS caused by bleaching agents.
Methods. To test experimental desensitizing agents in TS caused by dental bleaching the authors selected 113 participants without TS and randomly treated them with T1-16% carbamide peroxide (14 days) or T2-35% hydrogen peroxide (single session). The period of the study was 14 days. Participants (in T1 and T2) used domestic-use (DU) or in office (IO) desensitizers (D): Control Group; (DU)- experimental dentifrice with 7,5% of Biosilicate micro-particles-(D1); Sensodyne® dentifrice-(D2); (DU)-Odontis RX Sensiblock® dentifrice-(D3); (IO)-Biosilicate micro-particles paste, 1:1-(D4); (IO)-bioglass type 45S5 paste, 1:1 (D6); (IO)-Desensebilize Nano P-(D6). On days 1, 3, 7, 10 and 14, the authors received the participants to apply IO desensitizers and to record TS with Visual Analogue Scale (VAS). Data was analyzed with two-way ANOVA (considering time and desensitizing as factors) and post-hoc Bonferroni test (α=0.05).
Results. The use of experimental desensitizing agents G2 and G5 did not cause significantly difference in TS comparing to baseline. TS was not significantly different when G2 was used after 16% carbamide peroxide and G5 after 35% hydrogen peroxide application. Self-perception TS values were significantly (p<0.001) higher than recorded VAS.
Conclusions. Experimental desensitizing agents containing Biosilicate® can prevent TS caused by bleaching agents: in dentifrice form when associated to 16% carbamide peroxide and in paste, when 35% hydrogen peroxide is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desensitizing therapy | Experimental | Other: Dental bleaching14 groups (7 treated with in-office dental bleaching and 7 treated with home-use dental bleaching) . There will be 7 different types of dessensitizing agents that will be used together with the dental bleaching treatment |
| Dental Bleaching | Experimental | Other: Desensitizing therapy2 groups of dental bleaching treatment - 16% carbamide peroxide and 35% peroxide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients male or females, aged between 18 and 40 years.
- Smokers and nonsmokers.
- Patients with good general health.
- Patients with good oral health (no changes in hard or soft tissues).
- Have a minimum of 24 permanent teeth present and no restorations on anterior teeth.
Key exclusion criteria (7 listed)
- Patients with a medical history marked by chronic use of analgesics, anti-inflammatory and psychotropic drugs.
- Patients with braces or prostheses or restorations on anterior teeth.
- Patients with periodontal disease or poor oral hygiene.
- Patients with prior tooth sensitivity or have made use of desensitizing agents in the last three months.
- Patients who are pregnant or nursing.
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 bleachingAlso: Whitness Perfect®, Whitness HP®Home-use or in-office dental bleaching was performed in patients that received different types od desensitizing therapy | Other | Desensitizing therapy |
| Desensitizing therapyAlso: Dentifrice of Biosilicate, Sensodyne® dentifrice, Odontis RX Sensiblock, Biosilicate micro-particles paste, 1:1Participants (in T1 and T2) used domestic-use (DU) or in office (IO) desensitizers (D): Control Group; (DU)- experimental dentifrice with 7,5% of Biosilicate micro-particles-(D1); Sensodyne® dentifrice-(D2); (DU)-Odontis RX Sensiblock® dentifrice-(D3); (IO)-Biosilicate micro-particles paste, 1:1-(D4); (IO)-bioglass type 45S5 paste, 1:1 (D6); (IO)-Desensebilize Nano P-(D6). | Other | Dental Bleaching |
Primary outcome
Dentin hypersensitivity
Time frame: Baseline
The pain caused by dentin hypersensitivity was measured by stimulating cervical region of the teeth with a blast of air from a triple seringe and the patient will relate his/her pain in accordance with a visual analog scale (VAS) which consists of a 1 to 10 scale where the patients recorded their dentin hypersensitivity when stimulated. Dentin hypersensitivity (DH) was measured, using visual analogue scale, before the beginning of the treatments (baseline -T1 and T2) and during the next 14 days (1º, 3º, 7º, 10 º e 14º days)
5 secondary outcomes
Dentin hypersensitivity
Time frame: Day 1
Dentin hypersensitivity
Time frame: Day 3
Dentin hypersensitivity
Time frame: Day 7
Dentin hypersensitivity
Time frame: Day 10
Dentin hypersensitivity
Time frame: Day 14
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 Dec 2014.
- Dental School of Ribeirao Preto websiteLink provided by the sponsor.
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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.
Camila Tirapelli, PhD principal investigator
University of Sao Paulo
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 and Desensitizing therapy in people with Dentin Hypersensitivity, run by University of Sao Paulo 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 5 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 Dec 2014. 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.
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?
Dentin hypersensitivity (time frame: Baseline). 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 Dec 2014.