Evaluation of Sensitivity With and Without Sonic Activation of a Desensitizing Gel Before in Office Bleaching in Adults

Dentin Sensitivity Clinical Trial

Official title:

Sensitivity Absolute Risk Evaluation With and Without Sonic Activation of a Desensitizing Gel Previously to in Office Bleaching in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039270
• Other study ID #: 49123715.1.0000.5020
• Secondary ID: 1.310.594
• Status: Completed
• Phase: N/A
• First received: January 28, 2017
• Last updated: January 31, 2017
• Start date: January 18, 2016
• Est. completion date: April 15, 2016

Study information

• Verified date: January 2017
• Source: Federal University of Amazonas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 15, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Bleaching

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Faculty of Dentistry, Federal University of Amazonas	Manaus	Amazonas

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Amazonas	Coordination for the Improvement of Higher Education Personnel

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	Intensity of pain experienced, as measured by two pain scales.	Intensity of pain experienced	Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.