<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/NCT02232828</url>
  </required_header>
  <id_info>
    <org_study_id>CARIEX2or1</org_study_id>
    <nct_id>NCT02232828</nct_id>
  </id_info>
  <brief_title>Selective or Stepwise Removal of Deep Caries</brief_title>
  <official_title>Selective or Stepwise Removal of Deep Caries in Deciduous Molars: A Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rheinisch-Westfälische Technische Hochschule RWTH Aachen, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: For treating deep caries lesions, selective or stepwise, i. e. one- and two-step&#xD;
      incomplete excavation seems advantageous compared with complete caries removal. However,&#xD;
      current evidence regarding the success, as defined by not requiring any re-treatments, or&#xD;
      survival of teeth after different excavations is insufficient for definitive recommendation,&#xD;
      especially when treating deciduous teeth. Moreover, restoration integrity has not been&#xD;
      comparatively analyzed longitudinally, and neither patients', dentists' or parents'&#xD;
      preferences nor the clinical long-term costs emanating from both initial and re-treatments&#xD;
      have been reported yet.&#xD;
&#xD;
      Our primary hypothesis is that success rates differ significantly between selectively and&#xD;
      stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to&#xD;
      significantly differ between selectively and stepwise excavated teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment of deep caries lesions is associated with significant risks for the pulp,&#xD;
      including pulpal exposure and post-operative pulpal complications, which might eventually&#xD;
      compromise the retention of the tooth [1]. Moreover, treating deep lesions might be&#xD;
      associated with pain and subjective burden both during and after treatment and might generate&#xD;
      long-term costs due to re-treatments being required [2, 3].&#xD;
&#xD;
      For deciduous teeth, various treatments for deep lesions have been described: Complete&#xD;
      excavation aims at removing all infected and affected carious dentin, with the inherent risk&#xD;
      of pulpal exposure. In contrast, stepwise, i. e. two-step excavation leaves carious dentin&#xD;
      after the initial excavation step, then seals residual caries under a temporary restoration,&#xD;
      and re-enters the cavity in a second step to eventually attempt complete excavation. This&#xD;
      approach is thought to facilitate arrest and remineralization of the lesion and to induce&#xD;
      development of tertiary dentin, thereby reducing the risk of pulpal exposure and&#xD;
      post-operative complications after the second excavation step [4, 5]. Since several studies&#xD;
      found sealed residual lesions to be clinically and microbiologically arrested, the need to&#xD;
      re-enter was increasingly questioned within the last decade [6]. Selective, i. e. one-step&#xD;
      incomplete or partial excavation seals carious dentin under a definitive restoration,&#xD;
      omitting any re-entry [7]. Sealing the lesion is thought to deprive residual bacteria from&#xD;
      dietary carbohydrates and was found to exert significant antibacterial effects, thus&#xD;
      arresting the lesion [8, 9].&#xD;
&#xD;
      However, doubts remain regarding the effects of sealed carious dentin on the long-term&#xD;
      quality of the restoration [10]. Moreover, it remains unknown if patients prefer one of both&#xD;
      treatments, which might be especially relevant when treating children. Several studies&#xD;
      comparing complete with selective or stepwise excavation of deciduous teeth have been&#xD;
      published, but only one three-arm study compared selective with stepwise excavation of&#xD;
      primary teeth (Tab. 1). In addition, none of these studies assessed patient- or&#xD;
      dentists-centered outcomes, i. e. preferences, or analyzed clinically assessed long-term&#xD;
      costs emanating from both excavations.&#xD;
&#xD;
      Objectives and Hypotheses The study aims at comparing the success, i. e. the probability of&#xD;
      not requiring any re-interventions, and the survival, i. e. the probability of not requiring&#xD;
      tooth removal, of selectively versus stepwise excavated vital, non-symptomatic deciduous&#xD;
      molars with deep lesions. In addition, we assess the restoration integrity of selectively&#xD;
      versus stepwise excavated deciduous molars, evaluate the preference of patients, parents and&#xD;
      dentists for one of both strategies, and comparatively assess the costs associated with each&#xD;
      strategy.&#xD;
&#xD;
      Our primary hypothesis is that success rates differ significantly between selectively and&#xD;
      stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to&#xD;
      significantly differ between selectively and stepwise excavated teeth. Moreover, we&#xD;
      hypothesize that patients', parents' and dentists' preference is significantly different for&#xD;
      selective versus stepwise excavated teeth. Eventually, both initial and long-term costs of&#xD;
      excavation methods are supposed to significantly differ.&#xD;
&#xD;
      The planned study is a secondary care-based prospective, multi-center two-arm,&#xD;
      parallel-group, randomized controlled trial at three pediatric university dental clinics in&#xD;
      Germany. We plan to enroll 300 patients with one or more deeply carious, sensitive and&#xD;
      non-symptomatic deciduous molar. One molar per patient will be randomly allocated to receive&#xD;
      one of two treatments (selective or stepwise excavation). Total follow-up time will be three&#xD;
      years after completion of the initial treatment. Success, survival and restoration integrity&#xD;
      will be assessed after one, two and three years. Patients', parents' and dentists' preference&#xD;
      will be assessed after each treatment using visual-analogue scale or Likert-rating scales.&#xD;
      Costs will be assessed for initial and follow-up treatments and will be based on a&#xD;
      micro-costing approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success (re-intervention required no/yes)</measure>
    <time_frame>36 month</time_frame>
    <description>The primary outcome of the study will be success (i. e. not requiring any re-intervention).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival (tooth removal required no/yes)</measure>
    <time_frame>36 months</time_frame>
    <description>Secondary outcomes will include survival (i. e. not requiring extraction).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Restoration integrity (scored as alpha, beta, gamma, delta)</measure>
    <time_frame>36 months</time_frame>
    <description>Restoration integrity will be assessed via modified USPHS-criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' subjective assessment of the treatment (0-10)</measure>
    <time_frame>0 months (directly after treatment)</time_frame>
    <description>Patients' subjective assessment of the treatment will be recorded using visual-analogue scale. For stepwise excavation, assessments will be performed twice and mean VAS-results calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dentists' subjective assessment (1-6)</measure>
    <time_frame>0 months (directly after treatment)</time_frame>
    <description>Dentists' subjective assessment of the treatment will be reported using grades from 1 (very good) to 6 (very bad).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' subjective assessment (1-6)</measure>
    <time_frame>0 months (directly after treatment)</time_frame>
    <description>similar to dentists' assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment costs (Euro)</measure>
    <time_frame>36 months</time_frame>
    <description>Total treatment costs (calculated by combining costs for staff, as assessed by time required for the procedures and the number of personnel involved, and costs for transportation of patients or materials) for both initial and follow-up treatments.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Selective removal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Stepwise removal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Selective removal</intervention_name>
    <description>Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used.</description>
    <arm_group_label>Selective removal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stepwise removal</intervention_name>
    <description>Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used.&#xD;
If allocated to stepwise excavation, the second excavation will now be performed as described until only hard, dry dentin remains. Restoration will again be provided adhesively as described.</description>
    <arm_group_label>Stepwise removal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 3-9 yr&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
          -  Minimum one active deep (D3) occlusal/occlusal-proximal, one-/two-surface caries&#xD;
             lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in other study&#xD;
&#xD;
          -  Plan to move or not resident&#xD;
&#xD;
          -  Systemic disease or general disability&#xD;
&#xD;
          -  Expected limited compliance&#xD;
&#xD;
          -  Known allergy to study material expected exfoliation within 18 month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Falk Schwendicke, OA Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chatrite Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sebastian Paris, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Charite Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Finke, OA Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marina A. Petrou, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uniklinic RWTH Aachen, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christian Spleith, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Greifswald, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ruth Santamaria, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Greifswald, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Falk Schwendicke, OA Dr.</last_name>
    <phone>+4930450562</phone>
    <phone_ext>556</phone_ext>
    <email>falk.schwendicke@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sebastian Paris, Prof. Dr.</last_name>
    <phone>+4930450562</phone>
    <phone_ext>332</phone_ext>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ernst-Moritz-Arndt University of Greifswald, Präventive Zahnmedizin und Kinderzahnheilkunde</name>
      <address>
        <city>Greifswald</city>
        <state>Mecklenburg Vorpommern</state>
        <zip>17487</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christian Splieth, Prof. Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Ruth Santamaria, Dr.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Christian Splieth, Prof. Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ruth Santamaria, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen; Klinik für Zahnerhaltung, Parodontologie und Präventive Zahnheilkunde</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina A. Petrou, Dr.</last_name>
    </contact>
    <investigator>
      <last_name>Marina A. Petrou, Dr.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin, Abteilung für Kieferorthopädie, Orthodontie und Kinderzahnmedizin</name>
      <address>
        <city>Berlin</city>
        <zip>14197</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Finke, OA Dr.</last_name>
      <phone>+49450562</phone>
      <phone_ext>0</phone_ext>
      <email>Christian.Finke@charite.de</email>
    </contact>
    <investigator>
      <last_name>Christian Finke, OA Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CharitéCentrum für Zahn-, Mund- und Kieferheilkunde der Charité - Universitätsmedizin Berlin; Abteilungen für Zahnerhaltung und Präventive Zahnheilkunde</name>
      <address>
        <city>Berlin</city>
        <zip>14197</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Falk Schwendicke, OA Dr.</last_name>
      <phone>+4930450562</phone>
      <phone_ext>556</phone_ext>
      <email>falk.schwenicke@charite.de</email>
    </contact>
    <contact_backup>
      <last_name>Sebastian Paris, Prof. Dr.</last_name>
      <phone>+4930450562</phone>
      <phone_ext>332</phone_ext>
      <email>sebastian.paris@charite.de</email>
    </contact_backup>
    <investigator>
      <last_name>Falk Schwendicke, OA Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Falk Schwendicke</investigator_full_name>
    <investigator_title>OA Dr.</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>
  <!-- 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/NCT02232828
org study id: CARIEX2or1
nct id: NCT02232828
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Background: For treating deep caries lesions, selective or stepwise, i. e. one- and two-step
      incomplete excavation seems advantageous compared with complete caries removal. However,
      current evidence regarding the success, as defined by not requiring any re-treatments, or
      survival of teeth after different excavations is insufficient for definitive recommendation,
      especially when treating deciduous teeth. Moreover, restoration integrity has not been
      comparatively analyzed longitudinally, and neither patients', dentists' or parents'
      preferences nor the clinical long-term costs emanating from both initial and re-treatments
      have been reported yet.

      Our primary hypothesis is that success rates differ significantly between selectively and
      stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to
      significantly differ between selectively and stepwise excavated teeth.
The treatment of deep caries lesions is associated with significant risks for the pulp,
      including pulpal exposure and post-operative pulpal complications, which might eventually
      compromise the retention of the tooth [1]. Moreover, treating deep lesions might be
      associated with pain and subjective burden both during and after treatment and might generate
      long-term costs due to re-treatments being required [2, 3].

      For deciduous teeth, various treatments for deep lesions have been described: Complete
      excavation aims at removing all infected and affected carious dentin, with the inherent risk
      of pulpal exposure. In contrast, stepwise, i. e. two-step excavation leaves carious dentin
      after the initial excavation step, then seals residual caries under a temporary restoration,
      and re-enters the cavity in a second step to eventually attempt complete excavation. This
      approach is thought to facilitate arrest and remineralization of the lesion and to induce
      development of tertiary dentin, thereby reducing the risk of pulpal exposure and
      post-operative complications after the second excavation step [4, 5]. Since several studies
      found sealed residual lesions to be clinically and microbiologically arrested, the need to
      re-enter was increasingly questioned within the last decade [6]. Selective, i. e. one-step
      incomplete or partial excavation seals carious dentin under a definitive restoration,
      omitting any re-entry [7]. Sealing the lesion is thought to deprive residual bacteria from
      dietary carbohydrates and was found to exert significant antibacterial effects, thus
      arresting the lesion [8, 9].

      However, doubts remain regarding the effects of sealed carious dentin on the long-term
      quality of the restoration [10]. Moreover, it remains unknown if patients prefer one of both
      treatments, which might be especially relevant when treating children. Several studies
      comparing complete with selective or stepwise excavation of deciduous teeth have been
      published, but only one three-arm study compared selective with stepwise excavation of
      primary teeth (Tab. 1). In addition, none of these studies assessed patient- or
      dentists-centered outcomes, i. e. preferences, or analyzed clinically assessed long-term
      costs emanating from both excavations.

      Objectives and Hypotheses The study aims at comparing the success, i. e. the probability of
      not requiring any re-interventions, and the survival, i. e. the probability of not requiring
      tooth removal, of selectively versus stepwise excavated vital, non-symptomatic deciduous
      molars with deep lesions. In addition, we assess the restoration integrity of selectively
      versus stepwise excavated deciduous molars, evaluate the preference of patients, parents and
      dentists for one of both strategies, and comparatively assess the costs associated with each
      strategy.

      Our primary hypothesis is that success rates differ significantly between selectively and
      stepwise excavated teeth. Secondary hypotheses are that restoration integrity is assumed to
      significantly differ between selectively and stepwise excavated teeth. Moreover, we
      hypothesize that patients', parents' and dentists' preference is significantly different for
      selective versus stepwise excavated teeth. Eventually, both initial and long-term costs of
      excavation methods are supposed to significantly differ.

      The planned study is a secondary care-based prospective, multi-center two-arm,
      parallel-group, randomized controlled trial at three pediatric university dental clinics in
      Germany. We plan to enroll 300 patients with one or more deeply carious, sensitive and
      non-symptomatic deciduous molar. One molar per patient will be randomly allocated to receive
      one of two treatments (selective or stepwise excavation). Total follow-up time will be three
      years after completion of the initial treatment. Success, survival and restoration integrity
      will be assessed after one, two and three years. Patients', parents' and dentists' preference
      will be assessed after each treatment using visual-analogue scale or Likert-rating scales.
      Costs will be assessed for initial and follow-up treatments and will be based on a
      micro-costing approach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success (re-intervention required no/yes)
time frame: 36 month
description: The primary outcome of the study will be success (i. e. not requiring any re-intervention).
measure: Survival (tooth removal required no/yes)
time frame: 36 months
description: Secondary outcomes will include survival (i. e. not requiring extraction).
measure: Restoration integrity (scored as alpha, beta, gamma, delta)
time frame: 36 months
description: Restoration integrity will be assessed via modified USPHS-criteria.
measure: Patients' subjective assessment of the treatment (0-10)
time frame: 0 months (directly after treatment)
description: Patients' subjective assessment of the treatment will be recorded using visual-analogue scale. For stepwise excavation, assessments will be performed twice and mean VAS-results calculated.
measure: Dentists' subjective assessment (1-6)
time frame: 0 months (directly after treatment)
description: Dentists' subjective assessment of the treatment will be reported using grades from 1 (very good) to 6 (very bad).
measure: Parents' subjective assessment (1-6)
time frame: 0 months (directly after treatment)
description: similar to dentists' assessment
measure: Treatment costs (Euro)
time frame: 36 months
description: Total treatment costs (calculated by combining costs for staff, as assessed by time required for the procedures and the number of personnel involved, and costs for transportation of patients or materials) for both initial and follow-up treatments.
arm group label: Selective removal
arm group type: Experimental
arm group label: Stepwise removal
arm group type: Active Comparator
intervention type: Procedure
intervention name: Selective removal
description: Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used.
arm group label: Selective removal
intervention type: Procedure
intervention name: Stepwise removal
description: Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used.
If allocated to stepwise excavation, the second excavation will now be performed as described until only hard, dry dentin remains. Restoration will again be provided adhesively as described.
arm group label: Stepwise removal
criteria: 
gender: All
minimum age: 3 Years
maximum age: 9 Years
healthy volunteers: No
last name: Falk Schwendicke, OA Dr.
role: Principal Investigator
affiliation: Chatrite Berlin, Germany
last name: Sebastian Paris, Prof. Dr.
role: Study Chair
affiliation: Charite Berlin, Germany
last name: Christian Finke, OA Dr.
role: Principal Investigator
affiliation: Charite Berlin, Germany
last name: Marina A. Petrou, Dr.
role: Principal Investigator
affiliation: Uniklinic RWTH Aachen, Germany
last name: Christian Spleith, Prof. Dr.
role: Principal Investigator
affiliation: University Greifswald, Germany
last name: Ruth Santamaria, Dr.
role: Principal Investigator
affiliation: University Greifswald, Germany
last name: Falk Schwendicke, OA Dr.
phone: +4930450562
phone ext: 556
email: falk.schwendicke@charite.de
last name: Sebastian Paris, Prof. Dr.
phone: +4930450562
phone ext: 332
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Falk Schwendicke
investigator title: OA Dr.
mesh term: Dental Caries