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

NCT03039270 | Completed DMC

• 2 other identifiers: 49123715.1.0000.50201.310.594
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity; Tooth Bleaching

Keywords

Tooth Sensitivity; Tooth Bleaching; Desensitizing agent; Sonic vibration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bleaching effectiveness

  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.

  Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.

Study Arms (2)

Control (Without sonic activation)

ACTIVE COMPARATOR

Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching.

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.

Other: With sonic activation (SMART Device®)

Interventions

With sonic activation (SMART Device®) 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.

Also known as: Sonic vibration

With sonic activation (SMART Device®)

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.

Control (Without sonic activation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of Amazonas: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

Faculty of Dentistry, Federal University of Amazonas

Manaus, Amazonas, 69025-050, Brazil

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Verônica Bertocco

  Federal University of Amazonas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate student

Model Details: Randomized, controlled clinical trial, triple-blind, split-mouth type.

Study Record Dates

• First Submitted: January 28, 2017
• First Posted: February 1, 2017
• Study Start: January 18, 2016
• Primary Completion: March 31, 2016
• Study Completion: April 15, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)