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

Primary Purpose

Dentin Sensitivity, Tooth Bleaching

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
With sonic activation (SMART Device®)
Control (Without sonic activation)
Sponsored by
Federal University of Amazonas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Tooth Sensitivity, Tooth Bleaching, Desensitizing agent, Sonic vibration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Faculty of Dentistry, Federal University of Amazonas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control (Without sonic activation)

With sonic activation (SMART Device®)

Arm Description

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

Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching.

Outcomes

Primary Outcome Measures

Absolute risk of tooth sensitivity
Number of patients experiencing sensitivity at least once during the two whitening sessions.

Secondary Outcome Measures

Bleaching effectiveness
Change of color of teeth after bleaching.
Intensity of pain experienced, as measured by two pain scales.
Intensity of pain experienced

Full Information

First Posted
January 28, 2017
Last Updated
January 31, 2017
Sponsor
Federal University of Amazonas
Collaborators
Coordination for the Improvement of Higher Education Personnel
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1. Study Identification

Unique Protocol Identification Number
NCT03039270
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 18, 2016 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
April 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Amazonas
Collaborators
Coordination for the Improvement of Higher Education Personnel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity, Tooth Bleaching
Keywords
Tooth Sensitivity, Tooth Bleaching, Desensitizing agent, Sonic vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled clinical trial, triple-blind, split-mouth type.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (Without sonic activation)
Arm Type
Active Comparator
Arm Description
Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching.
Arm Title
With sonic activation (SMART Device®)
Arm Type
Experimental
Arm Description
Desensitizing gel applied with sonic activation, 30 seconds per tooth, previously to the in-office bleaching.
Intervention Type
Other
Intervention Name(s)
With sonic activation (SMART Device®)
Other Intervention Name(s)
Sonic vibration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control (Without sonic activation)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Absolute risk of tooth sensitivity
Description
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.
Secondary Outcome Measure Information:
Title
Bleaching effectiveness
Description
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.
Title
Intensity of pain experienced, as measured by two pain scales.
Description
Intensity of pain experienced
Time Frame
Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verônica Bertocco
Organizational Affiliation
Federal University of Amazonas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, Federal University of Amazonas
City
Manaus
State/Province
Amazonas
ZIP/Postal Code
69025-050
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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