Dentin SensitivityNCT03039270
Evaluation of Sensitivity With and Without Sonic Activation of a Desensitizing Gel Before in Office Bleaching in Adults
A study testing With sonic activation (SMART Device®) in people with Dentin Sensitivity and Tooth Bleaching, run by Federal University of Amazonas at 1 site in Brazil.
Trial summary
This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted aiming to assess the absolute risk of sensitivity with and without sonic activation of a desensitizing gel previously to the in-office bleaching in adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity, Tooth Bleaching
- What is being tested?
- With sonic activation (SMART Device®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Jan 2016to 15 Apr 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients had at least six upper anterior teeth free of caries and restorations on the vestibular surface, and at least one central or canine incisor showing A2 or darker coloration, evaluated in comparison with a visual scale of color orientated by the value of the teeth (Vita Classical, Vita-Zahnfabrik- Germany).
Who cannot join
- Users of fixed orthodontic appliances, pregnant or lactating, with the presence of severe intrinsic stains on the teeth (spots on the use of tetracycline, fluorosis and depolluted teeth), who were taking any medication with action Anti-inflammatory and antioxidant, using desensitizing dentifrice and participants with previous history of dental sensitivity or any associated pathology (bruxism, gingival recession, non-carious lesion with dentin exposure).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Dentistry, Federal University of Amazonas
Manaus, Amazonas, 69025-050
About this study
Official title: Sensitivity Absolute Risk Evaluation With and Without Sonic Activation of a Desensitizing Gel Previously to in Office Bleaching in Adults.
This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted aiming to assess the absolute risk of sensitivity with and without sonic activation of a desensitizing gel previously to the in-office bleaching in adults.
Read the detailed description
This clinical trial evaluated the effect of sonic activation of a desensitizing gel on the occurrence of sensitivity associated with office bleaching. For this, 31 patients had their anterior superior teeth divided into right and left, according to the sonic activation (AS) or not (SS) of the desensitizer. Prior to bleaching, a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF2%, FGM Dental Products,SC, Brazil) was applied. Sonic activation was performed with a sonic device (Smart, FGM Dental Products, SC, Brazil) at the 170 MHz frequency. A hydrogen peroxide gel (Whiteness HP Maxx, FGM Dental Products, SC, Brazil) was used in two whitening sessions. It was also performed, evaluation of the presence of cracks in enamel, through transillumination. The color change was verified using two color scales and a spectrophotometer. The dental sensitivity was recorded through a sensitivity diary answered by the patient, in the period up to 48 hours after each bleaching session. The absolute risk of tooth sensitivity was compared using the McNemar test (= 5%). The color change was analyzed from the variation of units of scale vita (SGU) and through the value of ΔE, which were compared through Student t test (α = 5%).
- Conditions
- Dentin Sensitivity, Tooth Bleaching
- Being tested
- With sonic activation (SMART Device®), Control (Without sonic activation)
- Keywords
- Tooth Sensitivity, Tooth Bleaching, Desensitizing agent, Sonic vibration
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With sonic activation (SMART Device®)Other
Also called Sonic vibration
The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM, SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the sonic activation side, immediately after the gel's application, sonic activation(Smart Sonic Device, FGM, SC, Brazil) was performed for 1.5 minutes in total for side (30 seconds per tooth). After the time of 30 seconds in each of the three anterior teeth of the respective side, the gel was removed from teeth with cotton. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.
Control (Without sonic activation)Other
The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM,SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the side allocated for application without sonic activation, gel was kept for 10 minutes, after which it was removed from the teeth. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.
| Study group | Role | What they receive |
|---|---|---|
| Control (Without sonic activation) | Active comparator | Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching. Receives: Other: Control (Without sonic activation) |
| With sonic activation (SMART Device®) | Experimental | Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching. Receives: Other: With sonic activation (SMART Device®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute risk of tooth sensitivity
Number of patients experiencing sensitivity at least once during the two whitening sessions.
Measured: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
Secondary outcomes (2)
Bleaching effectiveness
Change of color of teeth after bleaching.
Measured: Measured by the difference between the baseline color and 30 days after the second bleaching session.
Intensity of pain experienced, as measured by two pain scales.
Intensity of pain experienced
Measured: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start18 Jan 2016
- Primary completion31 Mar 2016
- Study completion15 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies 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
- Model description
- Randomized, controlled clinical trial, triple-blind, split-mouth type.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Amazonas
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Principal investigator, Verônica Pereira de Lima Bertocco, Federal University of Amazonas
- Investigators
- Verônica Bertocco, Principal investigator, Federal University of Amazonas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039270
- Sponsor's protocol ID
- 49123715.1.0000.5020
- Other IDs
- 1.310.594
- Status last verified
- Jan 2017
- First submitted
- 28 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
- 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 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity Absolute Risk Evaluation With and Without Sonic Activation of a Desensitizing Gel Previously to in Office Bleaching in Adults.
- ClinicalTrials.gov ID
- NCT03039270
- Acronym / sponsor ID
- 49123715.1.0000.5020
- Conditions
- Dentin Sensitivity, Tooth Bleaching
- Keywords
- Tooth Sensitivity, Tooth Bleaching, Desensitizing agent, Sonic vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Federal University of AmazonasUniversity, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Study start
- 18 Jan 2016 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 1 Feb 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.
This randomized, controlled clinical trial, triple-blind, split-mouth type was conducted aiming to assess the absolute risk of sensitivity with and without sonic activation of a desensitizing gel previously to the in-office bleaching in adults.
Detailed description
This clinical trial evaluated the effect of sonic activation of a desensitizing gel on the occurrence of sensitivity associated with office bleaching. For this, 31 patients had their anterior superior teeth divided into right and left, according to the sonic activation (AS) or not (SS) of the desensitizer. Prior to bleaching, a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF2%, FGM Dental Products,SC, Brazil) was applied. Sonic activation was performed with a sonic device (Smart, FGM Dental Products, SC, Brazil) at the 170 MHz frequency. A hydrogen peroxide gel (Whiteness HP Maxx, FGM Dental Products, SC, Brazil) was used in two whitening sessions. It was also performed, evaluation of the presence of cracks in enamel, through transillumination. The color change was verified using two color scales and a spectrophotometer. The dental sensitivity was recorded through a sensitivity diary answered by the patient, in the period up to 48 hours after each bleaching session. The absolute risk of tooth sensitivity was compared using the McNemar test (= 5%). The color change was analyzed from the variation of units of scale vita (SGU) and through the value of ΔE, which were compared through Student t test (α = 5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled clinical trial, triple-blind, split-mouth type.
| Arm | Type | Receives |
|---|---|---|
| Control (Without sonic activation) | Active comparator | Other: Control (Without sonic activation)Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching. |
| With sonic activation (SMART Device®) | Experimental | Other: With sonic activation (SMART Device®)Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients had at least six upper anterior teeth free of caries and restorations on the vestibular surface, and at least one central or canine incisor showing A2 or darker coloration, evaluated in comparison with a visual scale of color orientated by the value of the teeth (Vita Classical, Vita-Zahnfabrik- Germany).
Key exclusion criteria (1 listed)
- Users of fixed orthodontic appliances, pregnant or lactating, with the presence of severe intrinsic stains on the teeth (spots on the use of tetracycline, fluorosis and depolluted teeth), who were taking any medication with action Anti-inflammatory and antioxidant, using desensitizing dentifrice and participants with previous history of dental sensitivity or any associated pathology (bruxism, gingival recession, non-carious lesion with dentin exposure).
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 |
|---|---|---|
| With sonic activation (SMART Device®)Also: Sonic vibrationThe operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM, SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the sonic activation side, immediately after the gel's application, sonic activation(Smart Sonic Device, FGM, SC, Brazil) was performed for 1.5 minutes in total for side (30 seconds per tooth). After the time of 30 seconds in each of the three anterior teeth of the respective side, the gel was removed from teeth with cotton. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied. | Other | With sonic activation (SMART Device®) |
| Control (Without sonic activation)The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM,SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the side allocated for application without sonic activation, gel was kept for 10 minutes, after which it was removed from the teeth. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied. | Other | Control (Without sonic activation) |
Primary outcome
Absolute risk of tooth sensitivity
Time frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
Number of patients experiencing sensitivity at least once during the two whitening sessions.
2 secondary outcomes
Bleaching effectiveness
Time frame: Measured by the difference between the baseline color and 30 days after the second bleaching session.
Intensity of pain experienced, as measured by two pain scales.
Time frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
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 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Dentin Sensitivity
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
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.
Verônica Bertocco principal investigator
Federal University of Amazonas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With sonic activation (SMART Device®) in people with Dentin Sensitivity and Tooth Bleaching, run by Federal University of Amazonas 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 1 inclusion and 1 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 Feb 2017. 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?
Absolute risk of tooth sensitivity (time frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.). 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 1 Feb 2017.