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Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity

Primary Purpose

Tooth Sensitivity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
3% potassium nitrate and 0.25% sodium fluoride
5% potassium nitrate and 2% sodium fluoride
Sponsored by
Universidade Federal do Amazonas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tooth Sensitivity

Eligibility Criteria

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

Inclusion Criteria:

  • Patients aged 18 years and older, of both sexes, who had to present at least six upper anterior teeth free of caries and restorations on the vestibular face, and at least one central or canine incisor showing coloration A2 or darker, evaluated in comparison to a visual value-oriented color scale of the teeth (Vita Classical®, Vita-Zahnfabrik- Germany).

Prior to the interventions, the signing of each participant's free and informed consent form (Appendix I) was obtained after due explanations about the nature of the study and the possible risks of the proposed treatments.

Exclusion Criteria:

  • The individuals excluded from the study were: users of fixed orthodontic appliances, patients with periodontal disease, pregnant or lactating, with severe intrinsic stains on the teeth (spots on the use of tetracycline, fluorosis and depolluted teeth), consuming any Anti-inflammatory and anti-oxidant drugs, using desensitizing dentifrice and participants with previous history of SD or any associated pathology (bruxism, gingival recession, non-carious lesion with dentin exposure).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    control group

    experimental group

    Arm Description

    In group 1 (G1-control), the operator applied a desensitizing gel based on 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2% ®, FGM , Joinville, Santa Catarina, Brazil) with the aid of a custom silicone tray, which was made from a model obtained from the patient, with a vacuum plasticizer. A small layer of the gel was placed on the surface of the tray that was in contact with the vestibular face of the upper anterior teeth of the participants. The tray remained in position in the mouth for 10 minutes, according to the manufacturer's specifications.

    In group 2 (G2-intervention group), the operator applied a desensitizing gel containing 3% potassium nitrate and 0.25% sodium fluoride (Ultra EZ®, Ultradent Products Inc, South Jordan, UT, Estados Unidos) with the help of a tray in which the material is stored on the vestibular surfaces of the upper anterior teeth of the participants. The tray remained in position in the mouth for 15 minutes, according to the manufacturer's specifications.

    Outcomes

    Primary Outcome Measures

    absolute risk of tooth sensibility
    Patients recorded the occurrence or not of tooth sensitivity (TS) in a sensitivity diary. Participants were asked to register if they experienced DS during treatment and up to 48 hours after bleaching. The Analogic Visual Scale (AVS) was used to assess pain. Each item was scored 0-10 (0- no pain and 10- pain as bad as can be).

    Secondary Outcome Measures

    sensitivity intensity
    Patients were asked to record their perception of tooth sensitivity (TS) during the first and second bleaching sessions using the five-point Numeric Rating Scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe]. Subjects were asked to record their experience with TS during the treatment, up to 1 h after bleaching, from 1 h to 24 h, and from 24 to 48 h after bleaching. They were also asked to record whether their experienced or not TS during the 30-day period after bleaching. As two bleaching sessions were performed, the highest score obtained in both bleaching sessions was considered for statistical purposes.
    effectiveness of tooth whitening - objective
    Color was recorded before the bleaching procedure, 7 days and 30 days after the end of the bleaching treatment using an objective method (Easyshade spectrophotometer, Vident, Brea, CA, USA). For each evaluation, three readings were performed using the CIELab system parameters, in which: L * indicates luminosity, a * represents color and saturation on the red-green axis and b * means color and saturation on the yellow-blue axis. Color evaluation was done in a room under artificial lightning conditions without interference from outside light. The color was checked at the middle third of the canine.
    effectiveness of tooth whitening - subjective
    Color was recorded before the bleaching procedure, 7 days and 30 days after the end of the bleaching treatment using a subjective (value-oriented shade guide Vita Classic). For subjective evaluation, the 16 color guides of the Vita Classical scale (Vita Zahnfabrik®, Bad Säckingen, Germany) were organized from the highest value (B1) to the lowest value (C4). Although the scale is not linear, it was organized by value representing a ranking for analysis purposes. Color evaluation was done in a room under artificial lightning conditions without interference from outside light. The color was checked at the middle third of the canine.

    Full Information

    First Posted
    October 2, 2017
    Last Updated
    October 25, 2017
    Sponsor
    Universidade Federal do Amazonas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03323372
    Brief Title
    Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity
    Official Title
    Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 21, 2016 (undefined)
    Primary Completion Date
    May 5, 2017 (Actual)
    Study Completion Date
    May 20, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Amazonas

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this randomized, double-blind controlled clinical study was to evaluate the absolute risk and intensity of sensitivity to dental bleaching in adults on the application of two different gels based on potassium nitrate and sodium fluoride from a prospective randomized clinical study.
    Detailed Description
    For this study, 56 volunteers who had an equal allocation rate between the groups (G1-control and G2-experimental) were selected for this study. Both gels act in the same way, the difference between them is the concentration. In both groups, the different desensitizing gels were applied to the vestibular surface of the anterior superior teeth with the aid of a tray, remaining in position according to the time specified by the manufacturers. In the control group, a gel based on 5% potassium nitrate and 2% sodium fluoride was used, while in the experimental group, the gel was based on 3% potassium nitrate and 0.25% sodium fluoride. After removal of the desensitizing gel, both groups were subjected to bleaching with 40% hydrogen peroxide gel for 40 minutes. Patients recorded an occurrence or not of dental sensitivity (SD) in a sensitivity diary for 48 hours. A Verbal Evaluation Scale (VRS) and a Visual Analogue Scale (VAS) were used for pain assessment. The values were organized into two categories: percentage of patients who presented SD at some time of treatment (absolute risk of sensitivity) and SD intensity. To evaluate the color before the first bleaching session, and after 7, 14 and 28 days, two methods were used: objective evaluation using the spectrophotometer and subjective evaluation using two color scales: Vita Classical and Vita Bleachedguide 3D-MASTER. An analysis of the data followed the intent-to-treat protocol and involved all randomly allocated participants. The absolute risk of SD was compared using Fisher's exact test (α = 5%). The Mann-Whitney test was used to compare the intensity of SD. Student's t test was used to compare the color change. The level of significance adopted in all tests was 5%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Sensitivity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    The design of this randomized, double blind, intervention study was structured based on the CONSORT (Consolidated Standards of Reporting Trials) standards.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    In group 1 (G1-control), the operator applied a desensitizing gel based on 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2% ®, FGM , Joinville, Santa Catarina, Brazil) with the aid of a custom silicone tray, which was made from a model obtained from the patient, with a vacuum plasticizer. A small layer of the gel was placed on the surface of the tray that was in contact with the vestibular face of the upper anterior teeth of the participants. The tray remained in position in the mouth for 10 minutes, according to the manufacturer's specifications.
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    In group 2 (G2-intervention group), the operator applied a desensitizing gel containing 3% potassium nitrate and 0.25% sodium fluoride (Ultra EZ®, Ultradent Products Inc, South Jordan, UT, Estados Unidos) with the help of a tray in which the material is stored on the vestibular surfaces of the upper anterior teeth of the participants. The tray remained in position in the mouth for 15 minutes, according to the manufacturer's specifications.
    Intervention Type
    Drug
    Intervention Name(s)
    3% potassium nitrate and 0.25% sodium fluoride
    Other Intervention Name(s)
    Ultra EZ
    Intervention Type
    Drug
    Intervention Name(s)
    5% potassium nitrate and 2% sodium fluoride
    Other Intervention Name(s)
    Desensibilize KF 2%
    Primary Outcome Measure Information:
    Title
    absolute risk of tooth sensibility
    Description
    Patients recorded the occurrence or not of tooth sensitivity (TS) in a sensitivity diary. Participants were asked to register if they experienced DS during treatment and up to 48 hours after bleaching. The Analogic Visual Scale (AVS) was used to assess pain. Each item was scored 0-10 (0- no pain and 10- pain as bad as can be).
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    sensitivity intensity
    Description
    Patients were asked to record their perception of tooth sensitivity (TS) during the first and second bleaching sessions using the five-point Numeric Rating Scale (0 = none, 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe]. Subjects were asked to record their experience with TS during the treatment, up to 1 h after bleaching, from 1 h to 24 h, and from 24 to 48 h after bleaching. They were also asked to record whether their experienced or not TS during the 30-day period after bleaching. As two bleaching sessions were performed, the highest score obtained in both bleaching sessions was considered for statistical purposes.
    Time Frame
    28 days
    Title
    effectiveness of tooth whitening - objective
    Description
    Color was recorded before the bleaching procedure, 7 days and 30 days after the end of the bleaching treatment using an objective method (Easyshade spectrophotometer, Vident, Brea, CA, USA). For each evaluation, three readings were performed using the CIELab system parameters, in which: L * indicates luminosity, a * represents color and saturation on the red-green axis and b * means color and saturation on the yellow-blue axis. Color evaluation was done in a room under artificial lightning conditions without interference from outside light. The color was checked at the middle third of the canine.
    Time Frame
    28 days
    Title
    effectiveness of tooth whitening - subjective
    Description
    Color was recorded before the bleaching procedure, 7 days and 30 days after the end of the bleaching treatment using a subjective (value-oriented shade guide Vita Classic). For subjective evaluation, the 16 color guides of the Vita Classical scale (Vita Zahnfabrik®, Bad Säckingen, Germany) were organized from the highest value (B1) to the lowest value (C4). Although the scale is not linear, it was organized by value representing a ranking for analysis purposes. Color evaluation was done in a room under artificial lightning conditions without interference from outside light. The color was checked at the middle third of the canine.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18 years and older, of both sexes, who had to present at least six upper anterior teeth free of caries and restorations on the vestibular face, and at least one central or canine incisor showing coloration A2 or darker, evaluated in comparison to a visual value-oriented color scale of the teeth (Vita Classical®, Vita-Zahnfabrik- Germany). Prior to the interventions, the signing of each participant's free and informed consent form (Appendix I) was obtained after due explanations about the nature of the study and the possible risks of the proposed treatments. Exclusion Criteria: The individuals excluded from the study were: users of fixed orthodontic appliances, patients with periodontal disease, pregnant or lactating, with severe intrinsic stains on the teeth (spots on the use of tetracycline, fluorosis and depolluted teeth), consuming any Anti-inflammatory and anti-oxidant drugs, using desensitizing dentifrice and participants with previous history of SD or any associated pathology (bruxism, gingival recession, non-carious lesion with dentin exposure).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leandro M Martins, doctorate
    Organizational Affiliation
    amazon federal university
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Different Concentrations of Potassium Nitrate in In-office Tooth Bleaching Sensitivity

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