<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/NCT02234609</url>
  </required_header>
  <id_info>
    <org_study_id>mARTIV</org_study_id>
    <secondary_id>76/2011</secondary_id>
    <nct_id>NCT02234609</nct_id>
  </id_info>
  <brief_title>Effectiveness of Modified Class IV Atraumatic Restorative Treatment</brief_title>
  <acronym>modARTIV</acronym>
  <official_title>Effectiveness of Modified Class IV Atraumatic Restorative Treatment - Results After 12 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Witten/Herdecke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Witten/Herdecke</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment in&#xD;
      many developing countries. Because, ART is intended to be operated in molars, and about 10%&#xD;
      of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was the&#xD;
      aim of this study to clinically evaluate a modified ART restoration technique for anterior&#xD;
      teeth as the traditional treatment approach did not show satisfying clinical results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atraumatic Restorative Treatment (ART) has become an evidence-based treatment in class I&#xD;
      caries cavities for countries with developing dental infrastructure. Though epidemiological&#xD;
      data also demonstrate restorative treatment needs in anterior teeth in several African&#xD;
      countries, scientific evidence for ART in this application appeared so far unrewarding.&#xD;
      Consequently, many carious teeth remain untreated or are scheduled for extraction. In&#xD;
      deciduous teeth, class III and IV ART presented 86% failures due to partial or complete loss&#xD;
      already within the first year, and longitudinal data in the permanent dentition are rare.&#xD;
      Survival rates of 71% after three years, and of 68% after six years in the same study cohort&#xD;
      were reported from Brazil.&#xD;
&#xD;
      Basically, ART appears to be an interesting treatment approach as it combines a manual cavity&#xD;
      preparation technique with the use of a glass-ionomer cement as an adhesive and fluoride&#xD;
      releasing restoration material. Biomechanical stress, however, is above-average in class IV&#xD;
      restorations when intending to reconstruct the incisal edge with glass-ionomer cement&#xD;
      resulting in reported high rates of restoration fractures or loss. It was therefore the aim&#xD;
      to evaluate the clinical effectiveness of a modified ART class IV restoration technique in a&#xD;
      clinical study. These data are to be compared with an historical control (original ART class&#xD;
      IV anatomical structure rebuilding restorations). Historical control data will be retrieved&#xD;
      from &quot;Jordan RA, Gaengler P, Markovic L, Zimmer S: Performance of Atraumatic Restorative&#xD;
      Tratment (ART) depending on operator-experience. J Public Health Dent 2010; 70: 176-80.&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number (and percentage) of class IV modified ART restorations with failures after 1 year of performance (failures are defined as loss of restoration and/or fractures): annual failure rate</measure>
    <time_frame>1 year</time_frame>
    <description>Sept 2012 - Sept 2013: participants will be followed-up after 1 year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>9 scale clinical evaluation scores of class IV modified ART restorations after 1 year of performance (scores are defined by Frencken et al. 1996): ART evaluation criteria</measure>
    <time_frame>1 year</time_frame>
    <description>Sept 2012 - Sept 2013: participants will be followed-up after 1 year ART evaluation criteria were published as follows: &quot;Frencken JF, Makoni F, Sithole W: Atraumatic Restorative Treatment and glas-ionomer sealants in a school oral health programme in Zimbabwe: Evaluation after 1 year. Caries Res 1996, 30:428-433&quot;. These index does clinically assess the dental restauration in 1 out of 9 categories from &quot;excellent&quot; to &quot;restoration lost&quot;.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>adults with incisor dental caries lesion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>modified ART class IV with glass ionomer cement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>modified ART class IV</intervention_name>
    <description>Carious tissue was removed with an excavator until a sound probing was obtained. Restorations were performed using a mechanically improved glass-ionomer cement for ART. The modified class IV ART restoration was inserted into the cavity using a spatula. By these restoration technique, the cavity was (i) sealed to stop further caries progression. The cavity was (ii) capped to protect the vital dentin-pulp-complex from external stimuli. The modified class IV ART was aimed at conserving the carious incisor for prospective functional use and for prolonging tooth preservation rather than at anatomical reconstruction of the tooth form for cosmetic reasons.</description>
    <arm_group_label>adults with incisor dental caries lesion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no class IV cavity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Zimmer, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Witten/Herdecke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>public dental ward at Kindergarten Wattenscheid in Brikama-Kabafita, West Coast Region of The Republic of The Gambia</name>
      <address>
        <city>Banjul</city>
        <country>Gambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Gambia</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Witten/Herdecke</investigator_affiliation>
    <investigator_full_name>PD Dr. A. Rainer Jordan</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>dentistry</keyword>
  <keyword>dental caries</keyword>
  <keyword>atraumatic restorative Treatment</keyword>
  <keyword>effectiveness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02234609
org study id: mARTIV
secondary id: 76/2011
nct id: NCT02234609
lead sponsor: 
has dmc: No
Atraumatic Restorative Treatment (ART) has become an accepted dental restoration treatment in
      many developing countries. Because, ART is intended to be operated in molars, and about 10%
      of all carious lesion by an age of 18 years appear in anterior teeth in Gambia, it was the
      aim of this study to clinically evaluate a modified ART restoration technique for anterior
      teeth as the traditional treatment approach did not show satisfying clinical results.
Atraumatic Restorative Treatment (ART) has become an evidence-based treatment in class I
      caries cavities for countries with developing dental infrastructure. Though epidemiological
      data also demonstrate restorative treatment needs in anterior teeth in several African
      countries, scientific evidence for ART in this application appeared so far unrewarding.
      Consequently, many carious teeth remain untreated or are scheduled for extraction. In
      deciduous teeth, class III and IV ART presented 86% failures due to partial or complete loss
      already within the first year, and longitudinal data in the permanent dentition are rare.
      Survival rates of 71% after three years, and of 68% after six years in the same study cohort
      were reported from Brazil.

      Basically, ART appears to be an interesting treatment approach as it combines a manual cavity
      preparation technique with the use of a glass-ionomer cement as an adhesive and fluoride
      releasing restoration material. Biomechanical stress, however, is above-average in class IV
      restorations when intending to reconstruct the incisal edge with glass-ionomer cement
      resulting in reported high rates of restoration fractures or loss. It was therefore the aim
      to evaluate the clinical effectiveness of a modified ART class IV restoration technique in a
      clinical study. These data are to be compared with an historical control (original ART class
      IV anatomical structure rebuilding restorations). Historical control data will be retrieved
      from "Jordan RA, Gaengler P, Markovic L, Zimmer S: Performance of Atraumatic Restorative
      Tratment (ART) depending on operator-experience. J Public Health Dent 2010; 70: 176-80."
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number (and percentage) of class IV modified ART restorations with failures after 1 year of performance (failures are defined as loss of restoration and/or fractures): annual failure rate
time frame: 1 year
description: Sept 2012 - Sept 2013: participants will be followed-up after 1 year
measure: 9 scale clinical evaluation scores of class IV modified ART restorations after 1 year of performance (scores are defined by Frencken et al. 1996): ART evaluation criteria
time frame: 1 year
description: Sept 2012 - Sept 2013: participants will be followed-up after 1 year ART evaluation criteria were published as follows: "Frencken JF, Makoni F, Sithole W: Atraumatic Restorative Treatment and glas-ionomer sealants in a school oral health programme in Zimbabwe: Evaluation after 1 year. Caries Res 1996, 30:428-433". These index does clinically assess the dental restauration in 1 out of 9 categories from "excellent" to "restoration lost".
arm group label: adults with incisor dental caries lesion
arm group type: Other
description: modified ART class IV with glass ionomer cement
intervention type: Device
intervention name: modified ART class IV
description: Carious tissue was removed with an excavator until a sound probing was obtained. Restorations were performed using a mechanically improved glass-ionomer cement for ART. The modified class IV ART restoration was inserted into the cavity using a spatula. By these restoration technique, the cavity was (i) sealed to stop further caries progression. The cavity was (ii) capped to protect the vital dentin-pulp-complex from external stimuli. The modified class IV ART was aimed at conserving the carious incisor for prospective functional use and for prolonging tooth preservation rather than at anatomical reconstruction of the tooth form for cosmetic reasons.
arm group label: adults with incisor dental caries lesion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan Zimmer, Professor
role: Study Chair
affiliation: Witten/Herdecke University
facility: 
country: Gambia
responsible party type: Principal Investigator
investigator affiliation: University of Witten/Herdecke
investigator full name: PD Dr. A. Rainer Jordan
investigator title: Assistant Professor
mesh term: Dental Caries