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Trial record 28 of 32 for:    FLUORIDE ION AND NITRATE ION

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

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ClinicalTrials.gov Identifier: NCT03039270
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Coordination for the Improvement of Higher Education Personnel
Information provided by (Responsible Party):
Verônica Pereira de Lima Bertocco, Federal University of Amazonas

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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Tooth Bleaching Other: With sonic activation (SMART Device®) Other: Control (Without sonic activation) Not Applicable

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%).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled clinical trial, triple-blind, split-mouth type.
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Sensitivity Absolute Risk Evaluation With and Without Sonic Activation of a Desensitizing Gel Previously to in Office Bleaching in Adults.
Actual Study Start Date : January 18, 2016
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : April 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Control (Without sonic activation)
Desensitizing gel applied without sonic activation, for 10 minutes, previously to the in-office bleaching.
Other: 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.

Experimental: With sonic activation (SMART Device®)
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.
Other Name: Sonic vibration




Primary Outcome Measures :
  1. Absolute risk of tooth sensitivity [ Time Frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours. ]
    Number of patients experiencing sensitivity at least once during the two whitening sessions.


Secondary Outcome Measures :
  1. Bleaching effectiveness [ Time Frame: Measured by the difference between the baseline color and 30 days after the second bleaching session. ]
    Change of color of teeth after bleaching.

  2. Intensity of pain experienced, as measured by two pain scales. [ Time Frame: Throughout two bleaching sessions, in the period immediately after bleaching up to 48 hours. ]
    Intensity of pain experienced



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039270


Locations
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Brazil
Faculty of Dentistry, Federal University of Amazonas
Manaus, Amazonas, Brazil, 69025-050
Sponsors and Collaborators
Federal University of Amazonas
Coordination for the Improvement of Higher Education Personnel
Investigators
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Principal Investigator: Verônica Bertocco Federal University of Amazonas

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Responsible Party: Verônica Pereira de Lima Bertocco, Graduate student, Federal University of Amazonas
ClinicalTrials.gov Identifier: NCT03039270     History of Changes
Other Study ID Numbers: 49123715.1.0000.5020
1.310.594 ( Other Identifier: Research Ethics Committee )
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Verônica Pereira de Lima Bertocco, Federal University of Amazonas:
Tooth Sensitivity
Tooth Bleaching
Desensitizing agent
Sonic vibration
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases