<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/NCT01727804</url>
  </required_header>
  <id_info>
    <org_study_id>Raucci-Neto</org_study_id>
    <nct_id>NCT01727804</nct_id>
  </id_info>
  <brief_title>Neodymiun:Yttrium Aluminum Garnet Laser in Caries Prevention of Primary Teeth: One-year Follow-up</brief_title>
  <official_title>Clinical Effect of Neodymiun:Yttrium Aluminum Garnet Laser in Occlusal Caries Prevention of Primary Teeth: One Year Follow up.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this controlled clinical study was to evaluate the Nd:YAG laser, with or without&#xD;
      fluoride, in prevention of occlusal caries in the primary dentition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this controlled clinical study was to evaluate the Neodymiun:yttrium aluminum&#xD;
      garnet laser, with or without fluoride, in prevention of occlusal caries in the primary&#xD;
      dentition. High caries risk children (7.6±1.4 years) were selected for this study and&#xD;
      received the following treatments: G1-1st molar was negative control, and the 2nd molar&#xD;
      received a resin sealant; G2-1st molar was negative control, and the 2nd molar received laser&#xD;
      irradiation (100 milliJoule, 5 Hertz - 0.5 Watts); G3-1st molar received only fluoride gel&#xD;
      and the 2nd molar received fluoride gel + laser irradiation; G4-1st molar received only&#xD;
      fluoride varnish and the 2nd molar received fluoride varnish + laser irradiation. Patients&#xD;
      were followed up to 12 months to evaluate the formation of white-spot lesions and/or caries&#xD;
      cavities by three calibrated observers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2009</start_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical evaluation of the presence of dental caries on tooth occlusal surface</measure>
    <time_frame>up to 1 year</time_frame>
    <description>The clinical evaluation of the volunteers was performed 1, 3, 6, 9 and 12 months after treatment application by three different calibrated appraisers who were blind to the performed treatment.&#xD;
The clinical and radiographic assessments of the caries lesions were recorded using the clinical criteria described by Chu et al.,(2009), which was adapted from Ekstrand's visual scoring system, and the sealant evaluation was adapted from Beiruti et al.,(2006)&#xD;
The units of measure are: The scores obtained were considered as the following: V0, V1 and/or R0 represented sound teeth(with no need for restorative treatment), which were assigned a score of 0; V3, V4 and R1 to R3 represented decayed teeth(with a need for restorative treatment), which were assigned a score of 1. Considering the sealant scores, if the tooth evaluated presented with a caries lesion, it was considered to be a decayed tooth(with a need for treatment), regardless the sealant retention status.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Caries in Occlusal Surface of Primary and Permanent Detition</condition>
  <arm_group>
    <arm_group_label>Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laser in caries prevention</intervention_name>
    <arm_group_label>Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subject age of 7 to 8 years, high caries risk (evaluated by oral hygiene, dietary&#xD;
             habits and fluoride exposure, according to Kidd 2011), with the first permanent molars&#xD;
             without caries cavities, restorations, enamel defects, morphological anomalies and/or&#xD;
             signals of fluorosis. Subjects had to be willing to comply with all study procedures&#xD;
             and protocols. They had to be residents of Ribeirão Preto or other nearby local&#xD;
             communities with the same water fluoridation pattern (to eliminate water fluoridation&#xD;
             as a potential con- founding variable). Subjects had to be healthy and the parents or&#xD;
             the child legal guardian need to be willing to sign the &quot;Authorization and informed&#xD;
             consent for research&quot; form. There were no gender restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suffering from systemic diseases, had a significant past or medical history with&#xD;
             conditions that may affect oral health (i.e., diabetes, HIV, heart conditions that&#xD;
             require antibiotic prophylaxis), were taking medications that may affect the oral&#xD;
             flora or salivary flow (e.g., antibiotic use in the past three months, drugs&#xD;
             associated with dry mouth / xerostomia), had in-office fluoride treatment within the&#xD;
             last three months prior to being enrolled in the study, or were not willing to stop&#xD;
             the use of any mouth rinse during the duration of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of Dentistry of Ribeirão Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <state>São Paulo</state>
        <zip>14040-904</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Regina Guenka Palma Dibb</investigator_full_name>
    <investigator_title>DDS, MS, Phd, Associated Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01727804
org study id: Raucci-Neto
nct id: NCT01727804
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this controlled clinical study was to evaluate the Nd:YAG laser, with or without
      fluoride, in prevention of occlusal caries in the primary dentition.
The aim of this controlled clinical study was to evaluate the Neodymiun:yttrium aluminum
      garnet laser, with or without fluoride, in prevention of occlusal caries in the primary
      dentition. High caries risk children (7.6±1.4 years) were selected for this study and
      received the following treatments: G1-1st molar was negative control, and the 2nd molar
      received a resin sealant; G2-1st molar was negative control, and the 2nd molar received laser
      irradiation (100 milliJoule, 5 Hertz - 0.5 Watts); G3-1st molar received only fluoride gel
      and the 2nd molar received fluoride gel + laser irradiation; G4-1st molar received only
      fluoride varnish and the 2nd molar received fluoride varnish + laser irradiation. Patients
      were followed up to 12 months to evaluate the formation of white-spot lesions and/or caries
      cavities by three calibrated observers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Clinical evaluation of the presence of dental caries on tooth occlusal surface
time frame: up to 1 year
description: The clinical evaluation of the volunteers was performed 1, 3, 6, 9 and 12 months after treatment application by three different calibrated appraisers who were blind to the performed treatment.
The clinical and radiographic assessments of the caries lesions were recorded using the clinical criteria described by Chu et al.,(2009), which was adapted from Ekstrand's visual scoring system, and the sealant evaluation was adapted from Beiruti et al.,(2006)
The units of measure are: The scores obtained were considered as the following: V0, V1 and/or R0 represented sound teeth(with no need for restorative treatment), which were assigned a score of 0; V3, V4 and R1 to R3 represented decayed teeth(with a need for restorative treatment), which were assigned a score of 1. Considering the sealant scores, if the tooth evaluated presented with a caries lesion, it was considered to be a decayed tooth(with a need for treatment), regardless the sealant retention status.
arm group label: Laser
arm group type: Experimental
intervention type: Other
intervention name: Laser in caries prevention
arm group label: Laser
criteria: 
gender: All
minimum age: 7 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Regina Guenka Palma Dibb
investigator title: DDS, MS, Phd, Associated Professor