<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/NCT03756025</url>
  </required_header>
  <id_info>
    <org_study_id>ART-ECC</org_study_id>
    <nct_id>NCT03756025</nct_id>
  </id_info>
  <brief_title>Atraumatic Restorative Treatment (ART) in Early Childhood Caries (ECC)</brief_title>
  <acronym>ART-ECC</acronym>
  <official_title>Atraumatic Restorative Treatment (ART) in Early Childhood Caries in Brazilian Babies: a Longitudinal Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Nossa Senhora da Conceicao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Nossa Senhora da Conceicao</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Considering the severity and high prevalence of ECC, as well as the importance of early&#xD;
      intervention and approach, the Atraumatic Restorative Treatment program, because of its&#xD;
      advantages, consists of an important treatment alternative. However, only a few studies&#xD;
      assess ART in babies affected by ECC. For this practice to be accepted as safe, scientific&#xD;
      evidence must be built through longitudinal studies to evaluate ART performance and to this&#xD;
      end, the present study is justified. Therefore, the aim of this research was to evaluate the&#xD;
      effectiveness of Atraumatic Restorative Treatment performed in babies suffering from ECC&#xD;
      after a 4-year period and compare the clinical performance of Atraumatic Restorations&#xD;
      performed with two different glass ionomer cements. The investigator's hypothesis is that&#xD;
      there is no difference in the clinical performance of ARTs performed with the different GICs.&#xD;
&#xD;
      The study is characterized by longitudinal follow-up of a randomized, double-blind,&#xD;
      split-mouth-type clinical trial performed in babies affected by early childhood caries. The&#xD;
      subjects were children of both sexes, aged between 18 and 36 months, with at least one&#xD;
      deciduous molar in each of the different dental quadrants, presenting active cavitated&#xD;
      lesions of shallow or medium depth, involving only the occlusal surface. The initial&#xD;
      convenience sample consisted of 100 deciduous molars of 25 children attending Bebê Clínica of&#xD;
      the School of Dentistry of the Federal University of Rio Grande do Sul-FO / UFRGS, Porto&#xD;
      Alegre-RS, Brazil;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is characterized by longitudinal follow-up of a randomized, double-blind,&#xD;
      split-mouth-type clinical trial performed in babies affected by early childhood caries. The&#xD;
      subjects were children of both sexes, aged between 18 and 36 months, with at least one&#xD;
      deciduous molar in each of the different dental quadrants, presenting active cavitated&#xD;
      lesions of shallow or medium depth, involving only the occlusal surface. The initial&#xD;
      convenience sample consisted of 100 deciduous molars of 25 children attending Bebê Clínica of&#xD;
      the School of Dentistry of the Federal University of Rio Grande do Sul-FO / UFRGS, Porto&#xD;
      Alegre-RS, Brazil; this number being based on similar studies published in the literature&#xD;
      [27, 28, 29]. The power of the sample was calculated using the PEPI program, version 4&#xD;
      (Computer Programs for Epidemiologists), for a significance level of 5%. Considering that the&#xD;
      average success percentage in two years of ART on primary teeth facings was 88%, and the&#xD;
      worst result found was 67% [30], the power obtained was of 70.1%.&#xD;
&#xD;
      All children in the study were enrolled in the oral health promotion program for babies, in&#xD;
      which mothers accompanied by their children individually received information and guidance on&#xD;
      food intake, breastfeeding, and oral hygiene. In addition to the guidance that was reinforced&#xD;
      at each visit, children received topical application of fluoride by brushing with acidulated&#xD;
      phosphate fluoride gel in four applications with intervals of one week, considering that all&#xD;
      had active cavities [31].&#xD;
&#xD;
      The clinical trial was performed through the experimental split-mouth model, in which the 25&#xD;
      selected children had their teeth distributed randomly through a random number table,&#xD;
      receiving ART restorations of a face with one of the two high-viscosity conventional glass&#xD;
      ionomer cements studied: Vitro Molar® (DFL, Rio de Janeiro, Brazil) and Ketac Molar Easy Mix®&#xD;
      (3M ESPE, St Paul, MN, USA). The atraumatic restorations were performed in the dental office&#xD;
      by a single operator trained in the ART Technique [20], who received the restorative material&#xD;
      already prepared by a trained auxiliary, ensuring blinding of the study. The restorative&#xD;
      procedure performed in relative isolation and without the use of anesthesia consisted of&#xD;
      removal of the carious tissue using hand instrument excavators and dentin spoons, with&#xD;
      subsequent conditioning of the cavity with a polyacrylic acid solution at 11.5% (DFL) applied&#xD;
      with a microbrush for 10 seconds. Immediately after, the cavity was washed and dried with&#xD;
      cotton balls. In this step, according to the randomization, the respective GIC was inserted&#xD;
      and subsequent digital compression was performed for 30 seconds. After occlusal adjustment,&#xD;
      the ARTs were protected with finish gloss Alfa Bond® (DFL).&#xD;
&#xD;
      Clinical assessments were carried out in three stages: after 1, 2 and 4 years. For this, the&#xD;
      oral health status of the children was assessed by the presence of visible plaque and caries&#xD;
      activity, and the quality of ART restorations by the ART criterion [20]. In the exams at 4&#xD;
      years, an additional assessment was done by means of the modified United States Public Health&#xD;
      Service (USPHS) criteria [32] and the Visible Plaque Index-VPI and Gingival Bleeding&#xD;
      Index-GBI [33]. Each evaluation was performed by a different blind examiner for the type of&#xD;
      GIC used in ART and calibrated with the respective intra-examiner correlation coefficients: 1&#xD;
      year (ART Criterion: Kappa=0.81), 2 years (ART Criterion: Kappa=0.83), and 4 years (ART&#xD;
      Criterion: Kappa=0.86; Modified USPHS Criteria: Kappa average=0.73; VPI: Kappa=0.79; caries&#xD;
      activity: Kappa=1.0).&#xD;
&#xD;
      For the analysis of the general clinical performance of ART, through the success rate among&#xD;
      the different GICs, the chi-square test was applied. In addition, the Mann-Whitney test was&#xD;
      used to compare each individual clinical criterion between the materials (retention and&#xD;
      anatomical shape, integrity and marginal discoloration, color of material, surface roughness&#xD;
      and secondary caries), with all tests at the level of significance of 5% (p &lt;0.05). The&#xD;
      Visible Plaque Index (VPI) and Gingival Bleeding Index (GBI), as well as caries activity were&#xD;
      expressed through frequencies distribution.&#xD;
&#xD;
      Database construction and analysis, and interpretation of results were obtained by using the&#xD;
      Statistical Package for the Social Sciences (SPSS), version 19.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2008</start_date>
  <completion_date type="Actual">June 1, 2009</completion_date>
  <primary_completion_date type="Actual">December 31, 2008</primary_completion_date>
  <phase>N/A</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>The study is characterized by longitudinal follow-up of a randomized, double-blind, split-mouth-type clinical trial performed in babies affected by early childhood caries</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Each evaluation was performed by a different blind examiner for the type of GIC used in ART Patients did not know what material was being used on their teeth.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical performance scale of restaruations through the ART(Atraumatic Restorative Treatment ) criterion.</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Success: Codes 0(Present, satisfactory), 1(Present, slight deficiency at cavity margin of less than 0.5 mm) and 7(Not present, other restorative treatment performed)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical performance scale of restaruations through the ART(Atraumatic Restorative Treatment ) criterion.</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Failure: Codes 2(Present, deficiency at cavity margin of 0.5 mm or more), 3(Present, fracture in restoration), 4(Present, fracture in tooth), and 8(Not present, tooth is not present)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical performance scale of restaruations through the USPHS(United States Public Health Service ) criteria.</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Success: Codes A=Alfa (Restoration is intact and fully retained) and B=Bravo (Restoration is partially retained with some portion of the restoration still intact)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical performance scale of restaruations through the USPHS(United States Public Health Service ) criteria.</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Failure: Codes C(Restoration is completely missing)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Early Childhood Caries</condition>
  <arm_group>
    <arm_group_label>Vitro Molar® (DFL, Rio de Janeiro, Brazil)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ART restorations of a face with one of the two high-viscosity conventional glass ionomer cements-Vitro Molar® (DFL, Rio de Janeiro, Brazil).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ART restorations of a face with one of the two high-viscosity conventional glass ionomer cements-Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Atraumatic Restorative Treatment (ART)</intervention_name>
    <description>The atraumatic restorations were performed in the dental office by a single operator trained in the ART Technique [20], who received the restorative material already prepared by a trained auxiliary, ensuring blinding of the study. The restorative procedure performed in relative isolation and without the use of anesthesia consisted of removal of the carious tissue using hand instrument excavators and dentin spoons, with subsequent conditioning of the cavity with a polyacrylic acid solution at 11.5% (DFL) applied with a microbrush for 10 seconds. Immediately after, the cavity was washed and dried with cotton balls. In this step, according to the randomization, the respective GIC was inserted and subsequent digital compression was performed for 30 seconds. After occlusal adjustment, the ARTs were protected with finish gloss Alfa Bond® (DFL).</description>
    <arm_group_label>Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).</arm_group_label>
    <arm_group_label>Vitro Molar® (DFL, Rio de Janeiro, Brazil)</arm_group_label>
    <other_name>ART</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of active carious cavitated lesions;&#xD;
&#xD;
          -  least one deciduous molar in each of the different dental quadrants;&#xD;
&#xD;
          -  caries of shallow or medium depth, involving only the occlusal surface.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who do not allow clinical procedures to be performed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nossa Senhora da Conceição Hospital</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>91350-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Nossa Senhora da Conceicao</investigator_affiliation>
    <investigator_full_name>Daniel Demétrio Faustino da Silva</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Early Childhood Caries</keyword>
  <keyword>Atraumatic Restorative Treatment</keyword>
  <keyword>Glass Ionomer Cement</keyword>
  <keyword>Deciduous Tooth</keyword>
  <keyword>Odontopediatrics</keyword>
  <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/NCT03756025
org study id: ART-ECC
nct id: NCT03756025
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Considering the severity and high prevalence of ECC, as well as the importance of early
      intervention and approach, the Atraumatic Restorative Treatment program, because of its
      advantages, consists of an important treatment alternative. However, only a few studies
      assess ART in babies affected by ECC. For this practice to be accepted as safe, scientific
      evidence must be built through longitudinal studies to evaluate ART performance and to this
      end, the present study is justified. Therefore, the aim of this research was to evaluate the
      effectiveness of Atraumatic Restorative Treatment performed in babies suffering from ECC
      after a 4-year period and compare the clinical performance of Atraumatic Restorations
      performed with two different glass ionomer cements. The investigator's hypothesis is that
      there is no difference in the clinical performance of ARTs performed with the different GICs.

      The study is characterized by longitudinal follow-up of a randomized, double-blind,
      split-mouth-type clinical trial performed in babies affected by early childhood caries. The
      subjects were children of both sexes, aged between 18 and 36 months, with at least one
      deciduous molar in each of the different dental quadrants, presenting active cavitated
      lesions of shallow or medium depth, involving only the occlusal surface. The initial
      convenience sample consisted of 100 deciduous molars of 25 children attending Bebê Clínica of
      the School of Dentistry of the Federal University of Rio Grande do Sul-FO / UFRGS, Porto
      Alegre-RS, Brazil;
The study is characterized by longitudinal follow-up of a randomized, double-blind,
      split-mouth-type clinical trial performed in babies affected by early childhood caries. The
      subjects were children of both sexes, aged between 18 and 36 months, with at least one
      deciduous molar in each of the different dental quadrants, presenting active cavitated
      lesions of shallow or medium depth, involving only the occlusal surface. The initial
      convenience sample consisted of 100 deciduous molars of 25 children attending Bebê Clínica of
      the School of Dentistry of the Federal University of Rio Grande do Sul-FO / UFRGS, Porto
      Alegre-RS, Brazil; this number being based on similar studies published in the literature
      [27, 28, 29]. The power of the sample was calculated using the PEPI program, version 4
      (Computer Programs for Epidemiologists), for a significance level of 5%. Considering that the
      average success percentage in two years of ART on primary teeth facings was 88%, and the
      worst result found was 67% [30], the power obtained was of 70.1%.

      All children in the study were enrolled in the oral health promotion program for babies, in
      which mothers accompanied by their children individually received information and guidance on
      food intake, breastfeeding, and oral hygiene. In addition to the guidance that was reinforced
      at each visit, children received topical application of fluoride by brushing with acidulated
      phosphate fluoride gel in four applications with intervals of one week, considering that all
      had active cavities [31].

      The clinical trial was performed through the experimental split-mouth model, in which the 25
      selected children had their teeth distributed randomly through a random number table,
      receiving ART restorations of a face with one of the two high-viscosity conventional glass
      ionomer cements studied: Vitro Molar® (DFL, Rio de Janeiro, Brazil) and Ketac Molar Easy Mix®
      (3M ESPE, St Paul, MN, USA). The atraumatic restorations were performed in the dental office
      by a single operator trained in the ART Technique [20], who received the restorative material
      already prepared by a trained auxiliary, ensuring blinding of the study. The restorative
      procedure performed in relative isolation and without the use of anesthesia consisted of
      removal of the carious tissue using hand instrument excavators and dentin spoons, with
      subsequent conditioning of the cavity with a polyacrylic acid solution at 11.5% (DFL) applied
      with a microbrush for 10 seconds. Immediately after, the cavity was washed and dried with
      cotton balls. In this step, according to the randomization, the respective GIC was inserted
      and subsequent digital compression was performed for 30 seconds. After occlusal adjustment,
      the ARTs were protected with finish gloss Alfa Bond® (DFL).

      Clinical assessments were carried out in three stages: after 1, 2 and 4 years. For this, the
      oral health status of the children was assessed by the presence of visible plaque and caries
      activity, and the quality of ART restorations by the ART criterion [20]. In the exams at 4
      years, an additional assessment was done by means of the modified United States Public Health
      Service (USPHS) criteria [32] and the Visible Plaque Index-VPI and Gingival Bleeding
      Index-GBI [33]. Each evaluation was performed by a different blind examiner for the type of
      GIC used in ART and calibrated with the respective intra-examiner correlation coefficients: 1
      year (ART Criterion: Kappa=0.81), 2 years (ART Criterion: Kappa=0.83), and 4 years (ART
      Criterion: Kappa=0.86; Modified USPHS Criteria: Kappa average=0.73; VPI: Kappa=0.79; caries
      activity: Kappa=1.0).

      For the analysis of the general clinical performance of ART, through the success rate among
      the different GICs, the chi-square test was applied. In addition, the Mann-Whitney test was
      used to compare each individual clinical criterion between the materials (retention and
      anatomical shape, integrity and marginal discoloration, color of material, surface roughness
      and secondary caries), with all tests at the level of significance of 5% (p <0.05). The
      Visible Plaque Index (VPI) and Gingival Bleeding Index (GBI), as well as caries activity were
      expressed through frequencies distribution.

      Database construction and analysis, and interpretation of results were obtained by using the
      Statistical Package for the Social Sciences (SPSS), version 19.0.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is characterized by longitudinal follow-up of a randomized, double-blind, split-mouth-type clinical trial performed in babies affected by early childhood caries
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Each evaluation was performed by a different blind examiner for the type of GIC used in ART Patients did not know what material was being used on their teeth.
measure: Clinical performance scale of restaruations through the ART(Atraumatic Restorative Treatment ) criterion.
time frame: Through study completion, an average of 1 year
description: Success: Codes 0(Present, satisfactory), 1(Present, slight deficiency at cavity margin of less than 0.5 mm) and 7(Not present, other restorative treatment performed)
measure: Clinical performance scale of restaruations through the ART(Atraumatic Restorative Treatment ) criterion.
time frame: Through study completion, an average of 1 year
description: Failure: Codes 2(Present, deficiency at cavity margin of 0.5 mm or more), 3(Present, fracture in restoration), 4(Present, fracture in tooth), and 8(Not present, tooth is not present)
measure: Clinical performance scale of restaruations through the USPHS(United States Public Health Service ) criteria.
time frame: Through study completion, an average of 1 year
description: Success: Codes A=Alfa (Restoration is intact and fully retained) and B=Bravo (Restoration is partially retained with some portion of the restoration still intact)
measure: Clinical performance scale of restaruations through the USPHS(United States Public Health Service ) criteria.
time frame: Through study completion, an average of 1 year
description: Failure: Codes C(Restoration is completely missing)
arm group label: Vitro Molar® (DFL, Rio de Janeiro, Brazil)
arm group type: Experimental
description: ART restorations of a face with one of the two high-viscosity conventional glass ionomer cements-Vitro Molar® (DFL, Rio de Janeiro, Brazil).
arm group label: Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).
arm group type: Active Comparator
description: ART restorations of a face with one of the two high-viscosity conventional glass ionomer cements-Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).
intervention type: Procedure
intervention name: Atraumatic Restorative Treatment (ART)
description: The atraumatic restorations were performed in the dental office by a single operator trained in the ART Technique [20], who received the restorative material already prepared by a trained auxiliary, ensuring blinding of the study. The restorative procedure performed in relative isolation and without the use of anesthesia consisted of removal of the carious tissue using hand instrument excavators and dentin spoons, with subsequent conditioning of the cavity with a polyacrylic acid solution at 11.5% (DFL) applied with a microbrush for 10 seconds. Immediately after, the cavity was washed and dried with cotton balls. In this step, according to the randomization, the respective GIC was inserted and subsequent digital compression was performed for 30 seconds. After occlusal adjustment, the ARTs were protected with finish gloss Alfa Bond® (DFL).
arm group label: Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).
arm group label: Vitro Molar® (DFL, Rio de Janeiro, Brazil)
other name: ART
criteria: 
gender: All
minimum age: 18 Months
maximum age: 36 Months
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Nossa Senhora da Conceicao
investigator full name: Daniel Demétrio Faustino da Silva
investigator title: Principal Investigator
sharing ipd: No