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Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening

Primary Purpose

Tooth Whitening, Sensitivity

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Selection and preparation of the volunteers
Evaluation of the tooth color
Relative isolation
Gingival protection barrier
Application of desensitizing gel
Hydrogen peroxide
Used a dentifrice
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Whitening focused on measuring Tooth whitening, Dentifrice, Sensitivity

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age of 18 years or older
  • good oral and general health
  • hygid anterior tooth with color shade higher than A2 on the Vita Classic scale (VITA Zahnfabrink, Bad Säckingen, Germany).

Exclusion Criteria:

  • smoking, pregnancy or breastfeeding
  • previous dental whitening
  • para-functional habits
  • dentin sensitivity
  • anterior tooth with restorations and carious lesions
  • non-vital discoloration
  • unsatisfactory restorations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Arm Description

    The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.

    The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.

    The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.

    The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.

    Outcomes

    Primary Outcome Measures

    The analysis of the reduction of sensitivity using the toothpaste during whitening.
    For sensitivity analysis was used the numerical analogue scale with scores ranging from 0 to 10.
    The evaluation of the tooth color using the toothpaste during whitening.
    For evaluation of the tooth color was performed by using a spectrophotometer. (Easyshade, Vident, Brea, CA, USA). The color was determined by EasyShade device.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    January 11, 2017
    Sponsor
    University of Campinas, Brazil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03019224
    Brief Title
    Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening
    Official Title
    Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening: Double Blind Controlled Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campinas, Brazil

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Introduction: The pain sensitivity associated with whitening is the main problem reported by patients during dental whitening, and the use of desensitizing dentifrices is an alternative for the treatment of sensitivity. Objective: To evaluate clinically the influence of desensitizing dentifrices applied through a plastic tray, reducing the pain sensitivity and color variation caused by the technique of in-office dental whitening, through a controlled double-blind clinical study. Methods: A longitudinal prospective study was conducted with 48 individuals, 18 years and 30 years of age, without gender distinction, who underwent in-office dental whitening using 35% hydrogen peroxide (Whiteness HP, FGM, Joinville , SC, Brazil) in three clinical sessions with a one-week interval between them. The volunteers used in the night for each bleaching session a plastic tray for 4 hours containing one of the dentifrices related to the experimental groups: Group 1 (Control) - Sucralose (S) (Biotype - Manipulation pharmacy); Group 2 (Active control) - Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever); Group 3 - Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive); Group 4 - 5% potassium nitrate (NP) and sodium fluoride with 1450 ppm fluorine (Sensodyne pro-enamel, GlaxoSmithKline). The evaluation of the sensitivity associated with the times of use of the plastic tray in the first session (S1: sensitivity before the tray, S2: sensitivity after the tray), in the second session (S3: sensitivity before the tray, S4: in the third session (S5: sensitivity before the tray, S6: sensitivity after the tray) used the analog numerical scale with scores from 0 to 10 and for the color evaluation the spectrophotometer (Easyshade, Vident, Brea, CA, Obtaining the data that were used in the CIELab system. The data were submitted to the multivariate analysis of variance (MANOVA) with repeated measurements and Lambda Wilks test with a 5% probability level to differentiate the groups. In addition, the factorial variance analysis (ANOVA) in one criterion was applied. Values of p <0.05 were considered statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Whitening, Sensitivity
    Keywords
    Tooth whitening, Dentifrice, Sensitivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Placebo Comparator
    Arm Description
    The use of desensitizing dentifrice [Sucralose (S) Control dentifrice)] in plastic tray.
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    The use of desensitizing dentifrice [Sodium fluoride (FS) with 1450ppm of fluorine (Close up triple, Unilever)] in plastic tray.
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    The use of desensitizing dentifrice [Arginine, calcium carbonate (ACC) and sodium monofluorophosphate with 1450 ppm fluorine (Colgate sensitive pro-relief, Colgate-Palmolive)] in plastic tray.
    Arm Title
    Group 4
    Arm Type
    Experimental
    Arm Description
    The use of desensitizing dentifrice [Sodium fluoride based dentifrice with 1450 ppm of fluorine associated with 5% potassium nitrate] in plastic tray.
    Intervention Type
    Procedure
    Intervention Name(s)
    Selection and preparation of the volunteers
    Intervention Description
    Patients who sought the postgraduate dental clinic for whitening were invited to participate in the study. They were informed by the researcher (dentist) about all the aspects of the study and who might participate or discontinue the participation at any moment during the treatment. In addition, it was clarified that their participation was voluntary and refusal to participate would not result in any penalty or loss of benefits.
    Intervention Type
    Procedure
    Intervention Name(s)
    Evaluation of the tooth color
    Intervention Description
    The evaluation of the tooth color was performed by using a spectrophotometer (Easyshade, Vident, Brea, CA, USA). The color was analysed with the tooth hydrated before of the start the first whitening session and one week after. The spectrophotometer was always used in the same position by a silicon guide, which was prepared with dental arch molds by adding high viscosity vinyl polysiloxane material (Express XT, 3M ESPE, Sumaré, SP, Brazil). After polymerization, an opening was made in the mold corresponding to the buccal surface of the upper central incisors, allowing the color of the tooth to be evaluated with the tip of the spectrophotometer at the height of the middle third.
    Intervention Type
    Procedure
    Intervention Name(s)
    Relative isolation
    Intervention Description
    The clinical procedures were performed under relative isolation using lip retractor (Arcflex, FGM, Joinville, SC, Brazil) and dental cotton rollers to apply a gingival protection barrier (Top Dam, FGM, Joinville, SC, Brazil) extending from right first molar to left first molar in both arches.
    Intervention Type
    Procedure
    Intervention Name(s)
    Gingival protection barrier
    Intervention Description
    The gingival protection barrier was placed over the margins and gingival papilla corresponding to the areas receiving the whitening gel with approximately 3 mm in height and photopolymerized for 20 seconds in each group of three tooth. Photo-activation was performed with high power LEDs (light intensity = 600mw / cm²) (RadiiCal, São Paulo, SP, Brazil).
    Intervention Type
    Procedure
    Intervention Name(s)
    Application of desensitizing gel
    Intervention Description
    The desensitizing gel containing 5% potassium nitrate associated with 2% sodium fluoride (Desensibilize KF 2%, FGM, Joinville, SC, Brazil) was applied with a microbrush (Brush KG, KG Sorensen, Cotia, SP) on the buccal surface from right first molar to left first molar in both arches and remaining for 10 minutes. Then, the desensitizer was then removed with water jet and disposable plastic suction cannula.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrogen peroxide
    Intervention Description
    The handling of 35% hydrogen peroxide (Whiteness HP, FGM, Joinville, SC, Brazil) followed the manufacturer's recommendations, which consisted of mixing 3 drops of 35%hydrogen peroxide for 1 drop of thickener, with this mixture being sufficient for application to at least three tooth. The gel remained in contact with the buccal surface of the tooth for 15 minutes and was removed with disposable plastic suction cannula and water wash. This procedure was performed three times per clinical session. The volunteers underwent three whitening clinical sessions with one week interval between them.
    Intervention Type
    Procedure
    Intervention Name(s)
    Used a dentifrice
    Intervention Description
    Among the clinical whitening sessions, each volunteer used an unidentified dentifrice corresponding to their experimental group, which was previously defined by means of a draw made by a dentist who did not participate in the study. Thus, the researcher (dentist) who provided the dentifrice and the volunteer were not aware of which experimental group belonged (i.e. double blind).
    Primary Outcome Measure Information:
    Title
    The analysis of the reduction of sensitivity using the toothpaste during whitening.
    Description
    For sensitivity analysis was used the numerical analogue scale with scores ranging from 0 to 10.
    Time Frame
    Through study completion up to 4 weeks placement of the tray.
    Title
    The evaluation of the tooth color using the toothpaste during whitening.
    Description
    For evaluation of the tooth color was performed by using a spectrophotometer. (Easyshade, Vident, Brea, CA, USA). The color was determined by EasyShade device.
    Time Frame
    Through study completion up to 4 weeks placement of the tray.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age of 18 years or older good oral and general health hygid anterior tooth with color shade higher than A2 on the Vita Classic scale (VITA Zahnfabrink, Bad Säckingen, Germany). Exclusion Criteria: smoking, pregnancy or breastfeeding previous dental whitening para-functional habits dentin sensitivity anterior tooth with restorations and carious lesions non-vital discoloration unsatisfactory restorations

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening

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