<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/NCT01710865</url>
  </required_header>
  <id_info>
    <org_study_id>041386</org_study_id>
    <nct_id>NCT01710865</nct_id>
  </id_info>
  <brief_title>Effectiveness of Two Sealant Materials Over 5 Years</brief_title>
  <official_title>Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of a new hydrophilic sealant&#xD;
      (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials&#xD;
      (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The new hydrophobic sealant material eliminates the step of prime and drying the tooth which&#xD;
      prevents from over drying the tooth surface and decreases chair time, which is important when&#xD;
      working with children. The null hypothesis is that there is no difference between the&#xD;
      materials. The alternate hypothesis is that the Ultraseal XT Hydro is a better material.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    withdrawn&#xD;
  </why_stopped>
  <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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in retention of sealants from baseline to five years</measure>
    <time_frame>Baseline and every year (baseline to five years)</time_frame>
    <description>The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every year for 5 years.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Caries</condition>
  <arm_group>
    <arm_group_label>Ultraseal Sealant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultraseal Sealant</intervention_name>
    <description>This is a newly developed hydrophilic sealant material.</description>
    <arm_group_label>Ultraseal Sealant</arm_group_label>
    <other_name>Ultraseal XT Hydro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultraseal Sealant</intervention_name>
    <description>This is a previously existing hydrophobic sealant material.</description>
    <arm_group_label>Ultraseal Sealant</arm_group_label>
    <other_name>Ultraseal XT Plus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children that are at a high risk of developing caries.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children that already have sealants or do not need them.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Sahza Hatibov-Kofman, D.D.S.FRCD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Orthodontics and Paediatric Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Clinic at Western University</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A2S9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>November 2, 2017</last_update_submitted>
  <last_update_submitted_qc>November 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caries prevention</keyword>
  <keyword>pit and fissure sealants</keyword>
  <!-- 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/NCT01710865
org study id: 041386
nct id: NCT01710865
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effectiveness of a new hydrophilic sealant
      (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials
      (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.
The new hydrophobic sealant material eliminates the step of prime and drying the tooth which
      prevents from over drying the tooth surface and decreases chair time, which is important when
      working with children. The null hypothesis is that there is no difference between the
      materials. The alternate hypothesis is that the Ultraseal XT Hydro is a better material.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in retention of sealants from baseline to five years
time frame: Baseline and every year (baseline to five years)
description: The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every year for 5 years.
arm group label: Ultraseal Sealant
arm group type: Experimental
description: Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.
intervention type: Other
intervention name: Ultraseal Sealant
description: This is a newly developed hydrophilic sealant material.
arm group label: Ultraseal Sealant
other name: Ultraseal XT Hydro
intervention type: Other
intervention name: Ultraseal Sealant
description: This is a previously existing hydrophobic sealant material.
arm group label: Ultraseal Sealant
other name: Ultraseal XT Plus
criteria: 
gender: All
minimum age: 2 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD
role: Principal Investigator
affiliation: Division of Orthodontics and Paediatric Dentistry
facility: 
country: Canada
responsible party type: Sponsor