<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03044171</url>
  </required_header>
  <id_info>
    <org_study_id>UFPara-001</org_study_id>
    <nct_id>NCT03044171</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Para</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Para</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effects of desensitizing agents on the dental bleaching process, testing&#xD;
      the hypothesis that they may prevent dental sensitivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this double blind, randomized and controlled clinical study, was to evaluate&#xD;
      the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth&#xD;
      that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25&#xD;
      volunteers were evaluated through the split-mouth model, where the hemiarcates were&#xD;
      ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes&#xD;
      the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group&#xD;
      treated with placebo + 1.1% sodium fluoride .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">February 23, 2017</completion_date>
  <primary_completion_date type="Actual">January 23, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stimulated pain intensity measure (P5)</measure>
    <time_frame>4 weeks</time_frame>
    <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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-stimulated pain intensity measure, (P28)</measure>
    <time_frame>28 days</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of stimulated pain</measure>
    <time_frame>2 months</time_frame>
    <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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>G-FLUOR+LASER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G-FLUOR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low Level Laser Therapy</intervention_name>
    <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.</description>
    <arm_group_label>G-FLUOR+LASER</arm_group_label>
    <other_name>LLLT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1.1% Sodium Fluoride</intervention_name>
    <description>Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.</description>
    <arm_group_label>G-FLUOR</arm_group_label>
    <arm_group_label>G-FLUOR+LASER</arm_group_label>
    <other_name>Fluoride therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>In-office dental bleaching</intervention_name>
    <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.</description>
    <arm_group_label>G-FLUOR</arm_group_label>
    <arm_group_label>G-FLUOR+LASER</arm_group_label>
    <other_name>35% hydrogen peroxide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Absence of active carious lesions;&#xD;
&#xD;
          -  Good oral hygiene;&#xD;
&#xD;
          -  Do not present hypersensitivity;&#xD;
&#xD;
          -  Do not smoke;&#xD;
&#xD;
          -  Not being pregnant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of periodontal disease;&#xD;
&#xD;
          -  Presence of cracks or fractures;&#xD;
&#xD;
          -  Presence of restorations and prostheses;&#xD;
&#xD;
          -  Presence of gastroesophageal dysfunction;&#xD;
&#xD;
          -  Patients with severe internal dental dimming.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <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.</citation>
    <PMID>21488723</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>26964798</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>March 16, 2017</last_update_submitted>
  <last_update_submitted_qc>March 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Para</investigator_affiliation>
    <investigator_full_name>Cecy Martins Silva</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Hydrogen Peroxide</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>57655916.3.0000.0018</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisaAgrupador.jsf</doc_url>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03044171
org study id: UFPara-001
nct id: NCT03044171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the effects of desensitizing agents on the dental bleaching process, testing
      the hypothesis that they may prevent dental sensitivity.
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 .
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Stimulated pain intensity measure (P5)
time frame: 4 weeks
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).
measure: Non-stimulated pain intensity measure, (P28)
time frame: 28 days
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).
measure: Recurrence of stimulated pain
time frame: 2 months
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).
arm group label: G-FLUOR+LASER
arm group type: Experimental
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 group label: G-FLUOR
arm group type: Experimental
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: Low Level Laser Therapy
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.
arm group label: G-FLUOR+LASER
other name: LLLT
intervention type: Drug
intervention name: 1.1% Sodium Fluoride
description: Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.
arm group label: G-FLUOR
arm group label: G-FLUOR+LASER
other name: Fluoride therapy
intervention type: Drug
intervention name: In-office dental bleaching
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.
arm group label: G-FLUOR
arm group label: G-FLUOR+LASER
other name: 35% hydrogen peroxide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
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.
PMID: 21488723
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.
PMID: 26964798
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Para
investigator full name: Cecy Martins Silva
investigator title: Associate Professor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Listerine
mesh term: Hydrogen Peroxide
mesh term: Fluorides
mesh term: Sodium Fluoride
sharing ipd: No
study doc: 