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Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Low Level Laser Therapy
1.1% Sodium Fluoride
In-office dental bleaching
Sponsored by
Universidade Federal do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dentin Sensitivity

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Absence of active carious lesions;
  • Good oral hygiene;
  • Do not present hypersensitivity;
  • Do not smoke;
  • Not being pregnant.

Exclusion Criteria:

  • Presence of periodontal disease;
  • Presence of cracks or fractures;
  • Presence of restorations and prostheses;
  • Presence of gastroesophageal dysfunction;
  • Patients with severe internal dental dimming.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    G-FLUOR+LASER

    G-FLUOR

    Arm Description

    The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.

    The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching

    Outcomes

    Primary Outcome Measures

    Stimulated pain intensity measure (P5)
    Self reported stimulated pain intensity assessed weekly, by modified visual scale, at baseline, after first, second, third and fourth in-office bleaching application. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).

    Secondary Outcome Measures

    Non-stimulated pain intensity measure, (P28)
    Self reported non-stimulated pain intensity, assessed daily, by modified visual scale. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
    Recurrence of stimulated pain
    Return of stimulated pain after one month of the last intervention. Item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).

    Full Information

    First Posted
    January 30, 2017
    Last Updated
    March 16, 2017
    Sponsor
    Universidade Federal do Para
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03044171
    Brief Title
    Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth
    Official Title
    Effect of Sodium Fluoride at 1.1%, Associated or Not With the Low-level Light Therapy in the Prevention of Post-bleaching Sensitivity: a Randomized, Double-blind, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    January 23, 2017 (Actual)
    Study Completion Date
    February 23, 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    To investigate the effects of desensitizing agents on the dental bleaching process, testing the hypothesis that they may prevent dental sensitivity.
    Detailed Description
    The objective of this double blind, randomized and controlled clinical study, was to evaluate the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25 volunteers were evaluated through the split-mouth model, where the hemiarcates were ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group treated with placebo + 1.1% sodium fluoride .

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    G-FLUOR+LASER
    Arm Type
    Experimental
    Arm Description
    The corresponding hemiarcade received the application of Low Level Laser Therapy as a desensitizing treatment prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride after dental bleaching.
    Arm Title
    G-FLUOR
    Arm Type
    Experimental
    Arm Description
    The correspondent hemiarcade received only the positioning of the inactive laser tip (placebo), prior to in-office dental bleaching, followed by the application of 1.1% sodium fluoride as a desensitizing treatment after dental bleaching
    Intervention Type
    Device
    Intervention Name(s)
    Low Level Laser Therapy
    Other Intervention Name(s)
    LLLT
    Intervention Description
    Laser therapy: it was used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and central-medial region of the incisors, canines and premolars.
    Intervention Type
    Drug
    Intervention Name(s)
    1.1% Sodium Fluoride
    Other Intervention Name(s)
    Fluoride therapy
    Intervention Description
    Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.
    Intervention Type
    Drug
    Intervention Name(s)
    In-office dental bleaching
    Other Intervention Name(s)
    35% hydrogen peroxide
    Intervention Description
    Both groups received the in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 4 sessions, with a 7-day interval.
    Primary Outcome Measure Information:
    Title
    Stimulated pain intensity measure (P5)
    Description
    Self reported stimulated pain intensity assessed weekly, by modified visual scale, at baseline, after first, second, third and fourth in-office bleaching application. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Non-stimulated pain intensity measure, (P28)
    Description
    Self reported non-stimulated pain intensity, assessed daily, by modified visual scale. Each item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
    Time Frame
    28 days
    Title
    Recurrence of stimulated pain
    Description
    Return of stimulated pain after one month of the last intervention. Item is scored 0-3 (0 = no pain; 3 = pain as bad as can be).
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Absence of active carious lesions; Good oral hygiene; Do not present hypersensitivity; Do not smoke; Not being pregnant. Exclusion Criteria: Presence of periodontal disease; Presence of cracks or fractures; Presence of restorations and prostheses; Presence of gastroesophageal dysfunction; Patients with severe internal dental dimming.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21488723
    Citation
    Reis A, Dalanhol AP, Cunha TS, Kossatz S, Loguercio AD. Assessment of tooth sensitivity using a desensitizer before light-activated bleaching. Oper Dent. 2011 Jan-Feb;36(1):12-7. doi: 10.2341/10-148-CR. Epub 2011 Mar 24.
    Results Reference
    background
    PubMed Identifier
    26964798
    Citation
    Moosavi H, Arjmand N, Ahrari F, Zakeri M, Maleknejad F. Effect of low-level laser therapy on tooth sensitivity induced by in-office bleaching. Lasers Med Sci. 2016 May;31(4):713-9. doi: 10.1007/s10103-016-1913-z. Epub 2016 Mar 10.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf
    Available IPD/Information Identifier
    57655916.3.0000.0018

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    Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth

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