An interventional study of With sonic activation (SMART Device®) and Control (Without sonic activation) in Dentin Sensitivity and Tooth Bleaching, sponsored by Federal University of Amazonas. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Federal University of Amazonas · Not applicable, Interventional, and Treatment
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 ΔE, which were compared through Student t test (α = 5%).
283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.
This study's enrollment of 31 is below the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →Federal University of Amazonas is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching.
Other: Control (Without sonic activation)
Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching.
Other: With sonic activation (SMART Device®)
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.
Also known as: 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 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.
Absolute risk of tooth sensitivity
Number of patients experiencing sensitivity at least once during the two whitening sessions.
Time frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
Bleaching effectiveness
Change of color of teeth after bleaching.
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.
Intensity of pain experienced
Time frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
Plan to share: No
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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Federal University of Amazonas