<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/NCT03761485</url>
  </required_header>
  <id_info>
    <org_study_id>Acidulated fluoride dentifrice</org_study_id>
    <nct_id>NCT03761485</nct_id>
  </id_info>
  <brief_title>Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice</brief_title>
  <official_title>Dental Fluorosis Risk by the Use of Acidulated Fluoride Dentifrice: Clinical Trial - Epidemiological Study With Children Residing in an área Without Public Water Fluoridation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Paraíba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Paraíba</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>
      This research aimed to evaluate the risk of dental fluorosis by using an experimental&#xD;
      fluoridated acidulated dentifrice compared to conventional dentifrices in&#xD;
      two-to-four-year-old children residing in a non fluoridated area by the concentration of&#xD;
      fluoride incorporated in childrens' nails, as well as the incorporation of F into the&#xD;
      biofilm. Two hundred and ten children participated on this study. They were randomly&#xD;
      allocated into three groups differing according to the type of dentifrice used over 12&#xD;
      months: G1:1100 ppm F, pH 4.5; G2:750 ppm F, pH 4.5; G3:1100 ppm F, pH 7.0. The dentifrice&#xD;
      was placed on the toothbrush using the &quot;drop&quot; technique. The toenails of the biggest toe were&#xD;
      collected in three moments, corresponding to the experimental period of use of the&#xD;
      dentifrices (T1, T2 and T3), as well as the biofilm which was collected twice, 5 and 60&#xD;
      minutes after brushing. The nails and biofilm fluoride concentration were analyzed on a&#xD;
      specific electrode using the HMDS diffusion facilitated technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, interventional trial, adopting a strategy for collecting&#xD;
      data, collecting data from the children's biofilm. This study was carried out in three Child&#xD;
      Education Reference Centers (CREIs) located in different points of the city of João Pessoa&#xD;
      PB.&#xD;
&#xD;
      The city is located in the Northeast region of Brazil, on the coast of the state of Paraíba&#xD;
      and has about 600 thousand inhabitants (IBGE, 2013). João Pessoa has already had fluoridated&#xD;
      water for a period of two years until the mid-1980s, but so far the project has been&#xD;
      deactivated.&#xD;
&#xD;
      The 452 children participating in the study were divided into three groups according to the&#xD;
      dentifrice used in a 12 - month period: G1: 1,100 ppm F - pH 4.5; G2: 750 ppm F-pH 4.5; and&#xD;
      G3: 1100 ppm F-pH 7.0. The toothpaste was supplied by Oralls (São Jose dos Campos-SP, Brazil)&#xD;
      and dental brushes by Bitufo (Hypermarcas, São Paulo, SP-, Brazil) and there was no conflict&#xD;
      of interest. For the random distribution of the groups, the CREIs were considered as units,&#xD;
      so that only one type of toothpaste was distributed in each CREI, thus facilitating the&#xD;
      control of the dentifrices delivery by the teachers, as well as the supervised brushing in&#xD;
      CREI itself.&#xD;
&#xD;
      The toenails of the biggest toe were collected in three moments, corresponding to the&#xD;
      experimental period of use of the dentifrices (T1, T2 and T3), as well as the biofilm which&#xD;
      was collected twice, 5 and 60 minutes after brushing. The nails and biofilm fluoride&#xD;
      concentration were analyzed on a specific electrode using the HMDS diffusion facilitated&#xD;
      technique.&#xD;
&#xD;
      Nails of the large toes were collected because they provide a sufficient nail mass for&#xD;
      analysis and because there has been a reported possibility of contamination of the toenails&#xD;
      (Buzalaf, Pessan et al., 2006). The nail samples of each child were cleaned with deionized&#xD;
      water using a dental brush, taken to the ultrasound apparatus with deionized water for 10&#xD;
      min, dried at 60 ± 5 ° C and weighed on the analytical balance The presence of F was analyzed&#xD;
      as described in the previous item, according to the method of Taves (1968), as modified by&#xD;
      Whitford (1996). F patterns (0.00475, 0.0095, 0.019, 0.095, 0.190 and 0.95 mg F) were&#xD;
      prepared by serial dilution of a stock solution of 0.1 MF (Orion) in triplicate and diffused&#xD;
      in the same manner as the samples. The average repeatability of the readings based on&#xD;
      duplicate samples was 95%. Whenever the sample weight was&gt; 20 mg, the analysis was performed&#xD;
      in duplicate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2015</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized double blind clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of intraoral fluoride</measure>
    <time_frame>1 year</time_frame>
    <description>Effective of capacity to concentration of fluoride in biofilm (ppm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of intraoral fluoride - software</measure>
    <time_frame>1 year</time_frame>
    <description>Reduction of initial lesions carie give by mm² analysed by software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of intraoral fluoride</measure>
    <time_frame>1 year</time_frame>
    <description>Reduction of initial lesions carie give by visual scale (Nyvad scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of nail fluorid</measure>
    <time_frame>1 year</time_frame>
    <description>Concentration of fluoride in nail (ppm)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">452</enrollment>
  <condition>Caries, Dental</condition>
  <condition>Fluorosis, Dental</condition>
  <arm_group>
    <arm_group_label>Dentifrice 750 ppm of NaF acidulated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dentifrice 1.100 ppm of NaF neutral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dentifrice 1.100 ppm of NaF acidulated</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Use of Dentifrice Fluoride</intervention_name>
    <description>Use of few of dentifrice on brushing during a year</description>
    <arm_group_label>Dentifrice 1.100 ppm of NaF acidulated</arm_group_label>
    <arm_group_label>Dentifrice 1.100 ppm of NaF neutral</arm_group_label>
    <arm_group_label>Dentifrice 750 ppm of NaF acidulated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age group of 2 to 4 years of age of both sexes&#xD;
&#xD;
          -  Who were enrolled in one of the 3 CREIs that participated in the research&#xD;
&#xD;
          -  Presence of deciduos teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presented high mobility of the children (incompatible with the planning of a&#xD;
             longitudinal study)&#xD;
&#xD;
          -  Children who did not allow the clinical examination in the school&#xD;
&#xD;
          -  Children using orthodontic appliances or children with extensive caries lesions with&#xD;
             dentin sensitivity&#xD;
&#xD;
          -  Children not residing in the city of João Pessoa-PB from birth to 4 years due to the&#xD;
             fluoridation of water from public supply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Paraíba</investigator_affiliation>
    <investigator_full_name>Fabio Correia Sampaio</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Fluorosis, Dental</mesh_term>
    <mesh_term>Fluoride Poisoning</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03761485
org study id: Acidulated fluoride dentifrice
nct id: NCT03761485
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research aimed to evaluate the risk of dental fluorosis by using an experimental
      fluoridated acidulated dentifrice compared to conventional dentifrices in
      two-to-four-year-old children residing in a non fluoridated area by the concentration of
      fluoride incorporated in childrens' nails, as well as the incorporation of F into the
      biofilm. Two hundred and ten children participated on this study. They were randomly
      allocated into three groups differing according to the type of dentifrice used over 12
      months: G1:1100 ppm F, pH 4.5; G2:750 ppm F, pH 4.5; G3:1100 ppm F, pH 7.0. The dentifrice
      was placed on the toothbrush using the "drop" technique. The toenails of the biggest toe were
      collected in three moments, corresponding to the experimental period of use of the
      dentifrices (T1, T2 and T3), as well as the biofilm which was collected twice, 5 and 60
      minutes after brushing. The nails and biofilm fluoride concentration were analyzed on a
      specific electrode using the HMDS diffusion facilitated technique.
This is a randomized, double-blind, interventional trial, adopting a strategy for collecting
      data, collecting data from the children's biofilm. This study was carried out in three Child
      Education Reference Centers (CREIs) located in different points of the city of João Pessoa
      PB.

      The city is located in the Northeast region of Brazil, on the coast of the state of Paraíba
      and has about 600 thousand inhabitants (IBGE, 2013). João Pessoa has already had fluoridated
      water for a period of two years until the mid-1980s, but so far the project has been
      deactivated.

      The 452 children participating in the study were divided into three groups according to the
      dentifrice used in a 12 - month period: G1: 1,100 ppm F - pH 4.5; G2: 750 ppm F-pH 4.5; and
      G3: 1100 ppm F-pH 7.0. The toothpaste was supplied by Oralls (São Jose dos Campos-SP, Brazil)
      and dental brushes by Bitufo (Hypermarcas, São Paulo, SP-, Brazil) and there was no conflict
      of interest. For the random distribution of the groups, the CREIs were considered as units,
      so that only one type of toothpaste was distributed in each CREI, thus facilitating the
      control of the dentifrices delivery by the teachers, as well as the supervised brushing in
      CREI itself.

      The toenails of the biggest toe were collected in three moments, corresponding to the
      experimental period of use of the dentifrices (T1, T2 and T3), as well as the biofilm which
      was collected twice, 5 and 60 minutes after brushing. The nails and biofilm fluoride
      concentration were analyzed on a specific electrode using the HMDS diffusion facilitated
      technique.

      Nails of the large toes were collected because they provide a sufficient nail mass for
      analysis and because there has been a reported possibility of contamination of the toenails
      (Buzalaf, Pessan et al., 2006). The nail samples of each child were cleaned with deionized
      water using a dental brush, taken to the ultrasound apparatus with deionized water for 10
      min, dried at 60 ± 5 ° C and weighed on the analytical balance The presence of F was analyzed
      as described in the previous item, according to the method of Taves (1968), as modified by
      Whitford (1996). F patterns (0.00475, 0.0095, 0.019, 0.095, 0.190 and 0.95 mg F) were
      prepared by serial dilution of a stock solution of 0.1 MF (Orion) in triplicate and diffused
      in the same manner as the samples. The average repeatability of the readings based on
      duplicate samples was 95%. Whenever the sample weight was> 20 mg, the analysis was performed
      in duplicate.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized double blind clinical trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind
measure: Concentration of intraoral fluoride
time frame: 1 year
description: Effective of capacity to concentration of fluoride in biofilm (ppm)
measure: Effect of intraoral fluoride - software
time frame: 1 year
description: Reduction of initial lesions carie give by mm² analysed by software
measure: Effect of intraoral fluoride
time frame: 1 year
description: Reduction of initial lesions carie give by visual scale (Nyvad scale)
measure: Concentration of nail fluorid
time frame: 1 year
description: Concentration of fluoride in nail (ppm)
arm group label: Dentifrice 750 ppm of NaF acidulated
arm group type: Experimental
description: Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
arm group label: Dentifrice 1.100 ppm of NaF neutral
arm group type: Active Comparator
description: Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
arm group label: Dentifrice 1.100 ppm of NaF acidulated
arm group type: Active Comparator
description: Use of Dentifrice Fluoride Use of few of dentifrice on brushing for 12 months
intervention type: Other
intervention name: Use of Dentifrice Fluoride
description: Use of few of dentifrice on brushing during a year
arm group label: Dentifrice 1.100 ppm of NaF acidulated
arm group label: Dentifrice 1.100 ppm of NaF neutral
arm group label: Dentifrice 750 ppm of NaF acidulated
criteria: 
gender: All
minimum age: 2 Years
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Federal University of Paraíba
investigator full name: Fabio Correia Sampaio
investigator title: Professor
mesh term: Dental Caries
mesh term: Fluorosis, Dental
mesh term: Fluoride Poisoning
mesh term: Fluorides
sharing ipd: No