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| ID | Type | Description | Link |
|---|---|---|---|
| 1.310.594 | Other Identifier | Research Ethics Committee |
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| Name | Class |
|---|---|
| Coordination for the Improvement of Higher Education Personnel | OTHER |
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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.
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 ĪE, which were compared through Student t test (α = 5%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Without sonic activation) | Active Comparator | Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching. |
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| With sonic activation (SMART DeviceĀ®) | Experimental | Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With sonic activation (SMART DeviceĀ®) | 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 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute risk of tooth sensitivity | Number of patients experiencing sensitivity at least once during the two whitening sessions. | Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleaching effectiveness | Change of color of teeth after bleaching. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VerƓnica Bertocco | Federal University of Amazonas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Federal University of Amazonas | Manaus | Amazonas | 69025-050 | Brazil |
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Randomized, controlled clinical trial, triple-blind, split-mouth type.
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Neither the color evaluator nor the statistician were aware of the allocation of the hemiarcs, according to the sonic activation or not of them. In the execution of the intervention, the sonic activation was applied in sites such as marginal gingiva, premolars, palatal face of the teeth, in order to mask the treatment.
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| 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. |
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Intensity of pain experienced
| Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours. |
| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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