Clinical trial NCT03039270: Evaluation of Sensitivity With and Without Sonic Activation of a Desensitizing Gel Before in Office Bleaching in Adults
Official title: Sensitivity Absolute Risk Evaluation With and Without Sonic Activation of a Desensitizing Gel Previously to in Office Bleaching in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Tooth Bleaching
Keywords: Tooth Sensitivity
Tooth Bleaching
Desensitizing agent
Sonic vibration
Lead sponsor: Federal University of Amazonas
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
First posted: 2017-02-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled clinical trial, triple-blind, split-mouth type.
Primary purpose: TREATMENT

Brief 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.

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%).

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Absolute risk of tooth sensitivity
timeFrame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
Secondary outcomes:
measure: Bleaching effectiveness
timeFrame: Measured by the difference between the baseline color and 30 days after the second bleaching session.
measure: Intensity of pain experienced, as measured by two pain scales.
timeFrame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Faculty of Dentistry, Federal University of Amazonas
state: Amazonas
Study officials:
affiliation: Federal University of Amazonas
name: Verônica Bertocco
role: PRINCIPAL_INVESTIGATOR
References: