<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/NCT03039010</url>
  </required_header>
  <id_info>
    <org_study_id>MalmoU</org_study_id>
    <nct_id>NCT03039010</nct_id>
  </id_info>
  <brief_title>Validation of Data for Dental Health in the SKaPa Registry for Children and Adolescents</brief_title>
  <official_title>Validation of Data for Dental Health in the SKaPa Registry for Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tita Mensah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Malmö University</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>
      Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since&#xD;
      year 2008 gathered dental data. The data is automatically extracted from the patients'&#xD;
      electronical dental data records. A vast majority of the public dental health care clinics&#xD;
      deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop the&#xD;
      quality of care and patient outcomes for both prevention and reparative/restorative methods&#xD;
      concerning caries and periodontal disease. For children and adolescents, it is above all&#xD;
      information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has&#xD;
      published seven annual reports. In the report for year 2013 a limited information about the&#xD;
      status of children was given, due to uncertainty in the quality of the information that is&#xD;
      passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the&#xD;
      data supplied to SKaPa.&#xD;
&#xD;
      Tooth decay is the most common disease in children and adolescents that often lead to&#xD;
      invasive interventions and pain. There are reports of great social disparities in dental&#xD;
      health in children and adolescents in Sweden (The National Board of Health and Welfare,&#xD;
      Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important&#xD;
      to be able to monitor the occurrence of the disease and also examine how it differs across&#xD;
      various groups of children and adolescents. This is now possible through the several&#xD;
      registries that are available in the dental and health care. Register-based research will be&#xD;
      an important tool to ensure that children and adolescents receive oral health and dental care&#xD;
      on the same premise as others, provided the data in the registries are valid. Furthermore,&#xD;
      register-based research is important for development and quality assurance of dental care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Validation of data for dental health in the SKaPa registry for children and adolescents.&#xD;
&#xD;
      Research question: How reliable is the information on dental caries of children and&#xD;
      adolescents in the SKaPa registry?&#xD;
&#xD;
      Hypothesis: Data to SKaPa differences minimally compared with medical records and clinical&#xD;
      status when it comes to deft/DMFT for 6 and 12 year old children. There is an&#xD;
      underregistration of dental caries due to not registering caries that will not be treated.&#xD;
      The children that are examined with bite-wings will have a higher score of deft/DMFT than&#xD;
      other children.&#xD;
&#xD;
      Method: Tooth decay is examined clinically by trained and calibrated dentists in 170&#xD;
      6-year-olds and12-year-olds will be included. The registrations are compared with the most&#xD;
      recently collected data for individuals in SKaPa to evaluate the quality of the information&#xD;
      in the SKaPa registry. The inclusion of patients for the clinical dental examinations is&#xD;
      based on cluster sampling (dental clinic in the Public Dental Service) in Värmland. The exact&#xD;
      number of individuals being examined is determined after power calculation in collaboration&#xD;
      with a Biostatistician.&#xD;
&#xD;
      Furthermore, a randomized sample of 500 individuals where data reported to SKaPa for the year&#xD;
      2014 will included for evaluation of dental records and dental radiographs. Comparisons are&#xD;
      made between the data in the registry with the original data in the patient record.&#xD;
      Preliminary calculated 250 6-year-olds and 250 12-year-olds will be included. Study&#xD;
      population size is determined after power-calculation and in collaboration with a&#xD;
      statistician. The study would make it possible to detect differences in deft/DMFT at 10% with&#xD;
      a standard deviation of 30%. The reviews of the dental records are made by two calibrated&#xD;
      dentists. The consistency of registrations from dental records and radiographs are&#xD;
      continually evaluated throughout study. Primary outcome measures in both the clinical part&#xD;
      and the dental record survey are number of teeth and deft/ DMFT.&#xD;
&#xD;
      The following data are registered:&#xD;
&#xD;
        -  Status: Number of teeth, which teeth, manifest caries&#xD;
&#xD;
        -  Radiographs - manifest caries lesions, and quality of radiographs - for example;&#xD;
           possi-bility to see all interdental spaces, overlaps, marginal bone, quality of&#xD;
           radiographic exposure&#xD;
&#xD;
        -  Recordings in the dental records about patient's health status, medications, risk&#xD;
           assessment&#xD;
&#xD;
        -  Therapy decisions about diagnosed manifest tooth decay&#xD;
&#xD;
        -  Undiagnosed manifest caries&#xD;
&#xD;
        -  Prevention treatments&#xD;
&#xD;
        -  Which dental profession the child has met (dentist/dental hygienist/dental assistant)&#xD;
&#xD;
        -  Decision about when the next examination is planned&#xD;
&#xD;
        -  When the previous examination was done, was X-rays taken (yes/no), diagnosed caries&#xD;
           initially/manifest/or not&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of teeth and deft/ DMFT</measure>
    <time_frame>10 minutes</time_frame>
    <description>The dental caries index DMFT is commonly used to measure caries prevalence. DMFT means Decayed, Missing, Filled Teeth, i.e. carious, missing (due to tooth decay) and filled teeth in permanent dentition. In the primary dentition the terms used are; d (decayed), e (extracted) and f (filled) teeth.</description>
  </primary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Dental Caries in Children</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Study part 1: A total of 170 individuals (6-year-olds and 12-year-olds) will be included.&#xD;
&#xD;
        Part 2: A total of 500 individuals patient journals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion of patients for the clinical dental examinations is based on cluster&#xD;
             sampling (dental clinic in the Public Dental Service) in Värmland.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>National dental Service, Folktandvården Värmland</name>
      <address>
        <city>Karlstad</city>
        <state>Värmland</state>
        <zip>65220</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Malmö University</investigator_affiliation>
    <investigator_full_name>Tita Mensah</investigator_full_name>
    <investigator_title>Paediatric dentist, PhD candidate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_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/NCT03039010
org study id: MalmoU
nct id: NCT03039010
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Swedish Quality Registry for dental health care (SKaPa) is a national registry that has since
      year 2008 gathered dental data. The data is automatically extracted from the patients'
      electronical dental data records. A vast majority of the public dental health care clinics
      deliver data on a daily basis (SKaPa, 2013). SKaPa has the purpose to improve and develop the
      quality of care and patient outcomes for both prevention and reparative/restorative methods
      concerning caries and periodontal disease. For children and adolescents, it is above all
      information related to dental caries that is collected (SKaPa, 2013). So far, SKaPa has
      published seven annual reports. In the report for year 2013 a limited information about the
      status of children was given, due to uncertainty in the quality of the information that is
      passed on to SKaPa (SKaPa, 2013). There is therefore a need to examine the validity of the
      data supplied to SKaPa.

      Tooth decay is the most common disease in children and adolescents that often lead to
      invasive interventions and pain. There are reports of great social disparities in dental
      health in children and adolescents in Sweden (The National Board of Health and Welfare,
      Socialstyrelsen, 2013). Because tooth decay is a common disease in children, it is important
      to be able to monitor the occurrence of the disease and also examine how it differs across
      various groups of children and adolescents. This is now possible through the several
      registries that are available in the dental and health care. Register-based research will be
      an important tool to ensure that children and adolescents receive oral health and dental care
      on the same premise as others, provided the data in the registries are valid. Furthermore,
      register-based research is important for development and quality assurance of dental care.
Validation of data for dental health in the SKaPa registry for children and adolescents.

      Research question: How reliable is the information on dental caries of children and
      adolescents in the SKaPa registry?

      Hypothesis: Data to SKaPa differences minimally compared with medical records and clinical
      status when it comes to deft/DMFT for 6 and 12 year old children. There is an
      underregistration of dental caries due to not registering caries that will not be treated.
      The children that are examined with bite-wings will have a higher score of deft/DMFT than
      other children.

      Method: Tooth decay is examined clinically by trained and calibrated dentists in 170
      6-year-olds and12-year-olds will be included. The registrations are compared with the most
      recently collected data for individuals in SKaPa to evaluate the quality of the information
      in the SKaPa registry. The inclusion of patients for the clinical dental examinations is
      based on cluster sampling (dental clinic in the Public Dental Service) in Värmland. The exact
      number of individuals being examined is determined after power calculation in collaboration
      with a Biostatistician.

      Furthermore, a randomized sample of 500 individuals where data reported to SKaPa for the year
      2014 will included for evaluation of dental records and dental radiographs. Comparisons are
      made between the data in the registry with the original data in the patient record.
      Preliminary calculated 250 6-year-olds and 250 12-year-olds will be included. Study
      population size is determined after power-calculation and in collaboration with a
      statistician. The study would make it possible to detect differences in deft/DMFT at 10% with
      a standard deviation of 30%. The reviews of the dental records are made by two calibrated
      dentists. The consistency of registrations from dental records and radiographs are
      continually evaluated throughout study. Primary outcome measures in both the clinical part
      and the dental record survey are number of teeth and deft/ DMFT.

      The following data are registered:

        -  Status: Number of teeth, which teeth, manifest caries

        -  Radiographs - manifest caries lesions, and quality of radiographs - for example;
           possi-bility to see all interdental spaces, overlaps, marginal bone, quality of
           radiographic exposure

        -  Recordings in the dental records about patient's health status, medications, risk
           assessment

        -  Therapy decisions about diagnosed manifest tooth decay

        -  Undiagnosed manifest caries

        -  Prevention treatments

        -  Which dental profession the child has met (dentist/dental hygienist/dental assistant)

        -  Decision about when the next examination is planned

        -  When the previous examination was done, was X-rays taken (yes/no), diagnosed caries
           initially/manifest/or not
observational model: Cohort
time perspective: Prospective
measure: Number of teeth and deft/ DMFT
time frame: 10 minutes
description: The dental caries index DMFT is commonly used to measure caries prevalence. DMFT means Decayed, Missing, Filled Teeth, i.e. carious, missing (due to tooth decay) and filled teeth in permanent dentition. In the primary dentition the terms used are; d (decayed), e (extracted) and f (filled) teeth.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Malmö University
investigator full name: Tita Mensah
investigator title: Paediatric dentist, PhD candidate
mesh term: Dental Caries
sharing ipd: No