<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/NCT02191943</url>
  </required_header>
  <id_info>
    <org_study_id>CHARM</org_study_id>
    <nct_id>NCT02191943</nct_id>
  </id_info>
  <brief_title>Lesion Progression of Approximal Caries After Resin Infiltration</brief_title>
  <official_title>Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DMG Dental Material Gesellschaft mbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dep. Conservtive Dentistry, Periodontology and Preventive Dentistry Hannover</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DMG Dental Material Gesellschaft mbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the planned in-vivo trial is to investigate the effectiveness of the caries&#xD;
      infiltration technique for the repression of caries progression.&#xD;
&#xD;
      Within the framework of this investigation it is intended that the hypothesis to be&#xD;
      substantiated is that carious cavities, which have been treated with the caries infiltration&#xD;
      technique, exhibit significantly reduced radiological progression than those cavities that&#xD;
      have been treated using standard preventive treatments.&#xD;
&#xD;
      In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at&#xD;
      each institution are to be treated with both, the infiltration technique and using&#xD;
      conventional fluoridation treatment in different sides of the mouth (&quot;split-mouth design&quot;).&#xD;
&#xD;
      The anticipated result of this trial shall deliver information on the long-term effectiveness&#xD;
      of caries infiltration to prevent the progression of existing approximal carious lesions, and&#xD;
      thereby enable an improvement in caries prevention within the scope of dental treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the planned in-vivo trial is to investigate the effectiveness of the the caries&#xD;
      infiltration technique for the repression of approximal caries progression. .&#xD;
&#xD;
      Within the framework of this investigation it is intended that the hypothesis be&#xD;
      substantiated that carious cavities, which have been treated with the caries infiltration&#xD;
      technique, exhibit significantly reduced radiological progression than those cavities that&#xD;
      have been treated using standard treatments.&#xD;
&#xD;
      Modern dentistry, which is focused more towards preventive and minimally invasive treatment,&#xD;
      attempts - with the aid of fluoride therapies and improved oral hygiene - to prevent the&#xD;
      onset and progression of carious lesions as much as possible.&#xD;
&#xD;
      Even today, approximal lesions pose a particular problem to the treating dentist. A primary&#xD;
      reason for this is the difficulty accessing the localized area of the carious cavity.&#xD;
      Treating this area usually requires invasive treatment, in which healthy tooth structure must&#xD;
      be removed. Furthermore, it is possible that the filling material may deteriorate as a result&#xD;
      of the aging process, meaning that the restoration will require replacement at some point in&#xD;
      the future. In order to prevent this, the development of a treatment oriented towards&#xD;
      prevention and minimal invasion is key.&#xD;
&#xD;
      For a number of years there has been an option to seal pits and fissures on the occlusal&#xD;
      surfaces, which is assessed in the literature as being highly efficacious and effective&#xD;
      (Splieth et al. 2010, Ahovuo-Saloranta et al. 2008, Griffin et al. 2008). It constitutes a&#xD;
      vital component of the caries prevention approach especially in the event of an increased&#xD;
      risk of caries (Hiiri et al. 2010). In recent years there has been an attempt to transfer&#xD;
      this treatment concept to applications in the approximal area, in order to prevent&#xD;
      unnecessary substance ablation. A fissure sealing resin and a dental adhesive were used for&#xD;
      the first time in an attempt at creating a surface diffusion barrier (Gomez et al. 2008,&#xD;
      Gomez et al. 2005, Paris et al. 2006, Martignon et al. 2006, Robinson et al. 2001). Coating&#xD;
      the tooth surface in the approximal area with various plastic foils after tooth separation&#xD;
      opened up a whole new treatment approach for dealing with these carious lesions (Alkilzy et&#xD;
      al. 2010, 2009).&#xD;
&#xD;
      The caries infiltration technique constitutes an additional new treatment concept. Here, the&#xD;
      surface alone is not exclusively coated but a diffusion barrier is instead created inside the&#xD;
      cavity itself, through the penetration of the &quot;infiltrant&quot; into the carious lesion (Paris et&#xD;
      al. 2010, Meyer-Lueckel et al. 2010, 2009, 2008, Phark et al. 2009). In current studies, it&#xD;
      has been possible to demonstrate inhibition of the progression of carious lesions with the&#xD;
      infiltration technique, both in bovine teeth in situ and in artificially generated carious&#xD;
      lesions in human teeth in vitro (Paris et al. 2010).&#xD;
&#xD;
      The development of the infiltration technique started back in the 1970's with the first&#xD;
      low-viscosity plastic materials. However, these were never put into clinical application due&#xD;
      to their toxicity (Robinson et al.1976). During their course of development, adhesive systems&#xD;
      were employed for sealing carious lesions (Donly et al. 1992, Garcia-Godoy et al. 1997).&#xD;
      These also exhibit a caries-inhibiting effect. However, it has only been possible to&#xD;
      determine limited penetration depths. The reason for this is the surface morphology of the&#xD;
      carious cavity, with a very limited pore volume on the surface, and the characteristics of&#xD;
      the adhesive itself (Paris et al. 2007). In order to facilitate removal of the limiting&#xD;
      surface layer, a hydrochloric acid gel was used for the infiltration technique in place of&#xD;
      orthophosphoric acid gel for the adhesive technology. Using this conditioner it was possible&#xD;
      to guarantee better penetration of the materials up to a depth of 58 µm due to an erosive&#xD;
      removal of the surface layer (Meyer-Lueckel et al. 2007, Paris et al. 2007, 2009). In order&#xD;
      to better utilize the capillary effect in the altered surface and to thereby increase the&#xD;
      penetration depth of the material, monomer mixtures were developed with a high penetration&#xD;
      coefficient. These enable a fast penetration of the infiltrant into the altered carious&#xD;
      surface up to a depth of 750 µm (Paris et al. 2007, 2009). The sealing of the carious cavity&#xD;
      is now no longer restricted to the surface alone, but also encompasses the body of the&#xD;
      cavity.&#xD;
&#xD;
      The anticipated result of this trial shall deliver information on the long-term effectiveness&#xD;
      of caries infiltration and thereby result in an improvement in caries prevention within the&#xD;
      scope of dental treatment, and prevent the progression of existing carious lesions . This is&#xD;
      a micro-invasive form of treatment, which largely facilitates the delay or avoidance of&#xD;
      conventional invasive initial dental treatment with the associated inevitable loss of healthy&#xD;
      tooth structure. Further studies on the optimization of the infiltration technique can be&#xD;
      built upon these results. In the long-term, it will be possible to use these findings to&#xD;
      develop new prevention and treatment options for approximal carious lesion .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression of non-cavitated proximal caries lesions</measure>
    <time_frame>up to 36 months</time_frame>
    <description>preventing the progression of non-cavitated approximal lesions in comparison to conventional non invasive treatment; lesion progression will be monitored by annual bitewings and comparison to baseline lesion size</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Proximal Caries</condition>
  <arm_group>
    <arm_group_label>Control (fluoride varnish)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>resin infiltration (Icon)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duraphat</intervention_name>
    <description>The subjects in the control group will be the subject of personalized oral hygiene instructions on the basis of obtained indices, and will also receive a professional prophylaxis. Following this, the surfaces of the teeth in the control group involved in the trial will be treated with a fluoride varnish (Duraphat®) that will be applied with a brush to all surfaces of the teeth, working the varnish approximally with the brush. This treatment will be repeated in the comparative group at each follow-up appointment.</description>
    <arm_group_label>Control (fluoride varnish)</arm_group_label>
    <other_name>fluoride varnish</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Icon approximal caries infiltration kit</intervention_name>
    <description>Carious lesions in the teeth in the test group shall be treated with the infiltrant ICON® according to the manufacturer's instructions. Step by step instructions for application are as follows:</description>
    <arm_group_label>resin infiltration (Icon)</arm_group_label>
    <other_name>resin infiltration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years and older&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
          -  At least 2 active, approximal caries lesions present without evidence of frank&#xD;
             cavitation Caries depth: E2 - D1 (minimum extension to the inner half of the enamel&#xD;
             and maximum to the outer third of the dentin)&#xD;
&#xD;
          -  The posterior teeth on the upper and lower arches from distal of the first premolar to&#xD;
             mesial of the second molar will be included&#xD;
&#xD;
          -  All teeth to be treated must have approximal contacts with the adjacent teeth in the&#xD;
             arch&#xD;
&#xD;
          -  Other teeth requiring treatment will be treated prior to the beginning of the trial&#xD;
&#xD;
          -  The patients must declare their consent to participate in the clinical trial following&#xD;
             the provision of the required clarifications regarding the method, significance and&#xD;
             scope of the trial as well as the associated risks. They may withdraw this consent at&#xD;
             any time.&#xD;
&#xD;
          -  Participation in the follow-up examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Parallel participation in a further trial relating to dental materials&#xD;
&#xD;
          -  The patient has not signed the participant consent form&#xD;
&#xD;
          -  Pregnant and breastfeeding women prior to the trial commencing A woman that becomes&#xD;
             pregnant after the treatment has been performed will remain in the study, unless she&#xD;
             becomes pregnant for a second time in which case, she will be excluded from the study&#xD;
&#xD;
          -  Unexplained diseases of the mucous membranes or conditions in the sense of contact&#xD;
             allergies to materials used, e.g. oral lichenoid lesions&#xD;
&#xD;
          -  Known allergies to ingredients contained within the treatment materials used&#xD;
&#xD;
          -  Infectious diseases such as HIV, hepatitis, etc&#xD;
&#xD;
          -  Undergoing orthodontic treatment at the time of the trial&#xD;
&#xD;
          -  Persons who are presently taking other medication due to other illnesses, which upon&#xD;
             our examination are deemed to possibly be a risk or a problem for the patient or the&#xD;
             study&#xD;
&#xD;
          -  A large number of existing carious lesions that have not been restored and would&#xD;
             require extensive treatment, comprehensive prosthetic restorations that need to be&#xD;
             done or replaced and severe periodontal disease&#xD;
&#xD;
          -  Current use of bleaching products or use within the two weeks previous to the start of&#xD;
             the study&#xD;
&#xD;
          -  No assured dry isolation possible as required per the criteria of the adhesive&#xD;
             technology (rubber dam system)&#xD;
&#xD;
          -  Persons with a history of allergies&#xD;
&#xD;
          -  Patients with dental treatment phobias&#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>Silke Jacker-Guhr, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anne-Kathrin Lührs, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jack L Ferracane, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>January 22, 2015</last_update_submitted>
  <last_update_submitted_qc>January 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caries</keyword>
  <keyword>proximal</keyword>
  <keyword>non-cavitated</keyword>
  <keyword>fluoridation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Fluorides, Topical</mesh_term>
    <mesh_term>Sodium fluoride topical preparation</mesh_term>
  </intervention_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/NCT02191943
org study id: CHARM
nct id: NCT02191943
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of the planned in-vivo trial is to investigate the effectiveness of the caries
      infiltration technique for the repression of caries progression.

      Within the framework of this investigation it is intended that the hypothesis to be
      substantiated is that carious cavities, which have been treated with the caries infiltration
      technique, exhibit significantly reduced radiological progression than those cavities that
      have been treated using standard preventive treatments.

      In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at
      each institution are to be treated with both, the infiltration technique and using
      conventional fluoridation treatment in different sides of the mouth ("split-mouth design").

      The anticipated result of this trial shall deliver information on the long-term effectiveness
      of caries infiltration to prevent the progression of existing approximal carious lesions, and
      thereby enable an improvement in caries prevention within the scope of dental treatment.
The aim of the planned in-vivo trial is to investigate the effectiveness of the the caries
      infiltration technique for the repression of approximal caries progression. .

      Within the framework of this investigation it is intended that the hypothesis be
      substantiated that carious cavities, which have been treated with the caries infiltration
      technique, exhibit significantly reduced radiological progression than those cavities that
      have been treated using standard treatments.

      Modern dentistry, which is focused more towards preventive and minimally invasive treatment,
      attempts - with the aid of fluoride therapies and improved oral hygiene - to prevent the
      onset and progression of carious lesions as much as possible.

      Even today, approximal lesions pose a particular problem to the treating dentist. A primary
      reason for this is the difficulty accessing the localized area of the carious cavity.
      Treating this area usually requires invasive treatment, in which healthy tooth structure must
      be removed. Furthermore, it is possible that the filling material may deteriorate as a result
      of the aging process, meaning that the restoration will require replacement at some point in
      the future. In order to prevent this, the development of a treatment oriented towards
      prevention and minimal invasion is key.

      For a number of years there has been an option to seal pits and fissures on the occlusal
      surfaces, which is assessed in the literature as being highly efficacious and effective
      (Splieth et al. 2010, Ahovuo-Saloranta et al. 2008, Griffin et al. 2008). It constitutes a
      vital component of the caries prevention approach especially in the event of an increased
      risk of caries (Hiiri et al. 2010). In recent years there has been an attempt to transfer
      this treatment concept to applications in the approximal area, in order to prevent
      unnecessary substance ablation. A fissure sealing resin and a dental adhesive were used for
      the first time in an attempt at creating a surface diffusion barrier (Gomez et al. 2008,
      Gomez et al. 2005, Paris et al. 2006, Martignon et al. 2006, Robinson et al. 2001). Coating
      the tooth surface in the approximal area with various plastic foils after tooth separation
      opened up a whole new treatment approach for dealing with these carious lesions (Alkilzy et
      al. 2010, 2009).

      The caries infiltration technique constitutes an additional new treatment concept. Here, the
      surface alone is not exclusively coated but a diffusion barrier is instead created inside the
      cavity itself, through the penetration of the "infiltrant" into the carious lesion (Paris et
      al. 2010, Meyer-Lueckel et al. 2010, 2009, 2008, Phark et al. 2009). In current studies, it
      has been possible to demonstrate inhibition of the progression of carious lesions with the
      infiltration technique, both in bovine teeth in situ and in artificially generated carious
      lesions in human teeth in vitro (Paris et al. 2010).

      The development of the infiltration technique started back in the 1970's with the first
      low-viscosity plastic materials. However, these were never put into clinical application due
      to their toxicity (Robinson et al.1976). During their course of development, adhesive systems
      were employed for sealing carious lesions (Donly et al. 1992, Garcia-Godoy et al. 1997).
      These also exhibit a caries-inhibiting effect. However, it has only been possible to
      determine limited penetration depths. The reason for this is the surface morphology of the
      carious cavity, with a very limited pore volume on the surface, and the characteristics of
      the adhesive itself (Paris et al. 2007). In order to facilitate removal of the limiting
      surface layer, a hydrochloric acid gel was used for the infiltration technique in place of
      orthophosphoric acid gel for the adhesive technology. Using this conditioner it was possible
      to guarantee better penetration of the materials up to a depth of 58 µm due to an erosive
      removal of the surface layer (Meyer-Lueckel et al. 2007, Paris et al. 2007, 2009). In order
      to better utilize the capillary effect in the altered surface and to thereby increase the
      penetration depth of the material, monomer mixtures were developed with a high penetration
      coefficient. These enable a fast penetration of the infiltrant into the altered carious
      surface up to a depth of 750 µm (Paris et al. 2007, 2009). The sealing of the carious cavity
      is now no longer restricted to the surface alone, but also encompasses the body of the
      cavity.

      The anticipated result of this trial shall deliver information on the long-term effectiveness
      of caries infiltration and thereby result in an improvement in caries prevention within the
      scope of dental treatment, and prevent the progression of existing carious lesions . This is
      a micro-invasive form of treatment, which largely facilitates the delay or avoidance of
      conventional invasive initial dental treatment with the associated inevitable loss of healthy
      tooth structure. Further studies on the optimization of the infiltration technique can be
      built upon these results. In the long-term, it will be possible to use these findings to
      develop new prevention and treatment options for approximal carious lesion .
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: progression of non-cavitated proximal caries lesions
time frame: up to 36 months
description: preventing the progression of non-cavitated approximal lesions in comparison to conventional non invasive treatment; lesion progression will be monitored by annual bitewings and comparison to baseline lesion size
arm group label: Control (fluoride varnish)
arm group type: Active Comparator
arm group label: resin infiltration (Icon)
arm group type: Experimental
intervention type: Device
intervention name: Duraphat
description: The subjects in the control group will be the subject of personalized oral hygiene instructions on the basis of obtained indices, and will also receive a professional prophylaxis. Following this, the surfaces of the teeth in the control group involved in the trial will be treated with a fluoride varnish (Duraphat®) that will be applied with a brush to all surfaces of the teeth, working the varnish approximally with the brush. This treatment will be repeated in the comparative group at each follow-up appointment.
arm group label: Control (fluoride varnish)
other name: fluoride varnish
intervention type: Device
intervention name: Icon approximal caries infiltration kit
description: Carious lesions in the teeth in the test group shall be treated with the infiltrant ICON® according to the manufacturer's instructions. Step by step instructions for application are as follows:
arm group label: resin infiltration (Icon)
other name: resin infiltration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Silke Jacker-Guhr, Dr.
role: Principal Investigator
affiliation: Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School
last name: Anne-Kathrin Lührs, Dr.
role: Principal Investigator
affiliation: Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School
last name: Jack L Ferracane, Prof.
role: Study Chair
affiliation: OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fluorides
mesh term: Fluorides, Topical
mesh term: Sodium fluoride topical preparation