xml: <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/NCT05965297</url>
    </required_header>
    <id_info>
      <org_study_id>DeltaFill</org_study_id>
      <nct_id>NCT05965297</nct_id>
    </id_info>
    <brief_title>Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition</brief_title>
    <official_title>Comparison of Two Conventional Glass Ionomer Cements in the Restoration of Posterior Class II Lesion in the Primary Dentition: a Randomized Controlled Non Inferiority Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>DMG Dental Material Gesellschaft mbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Coimbra</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Arthur Sá Earp Neto</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>DMG Dental Material Gesellschaft mbH</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will investigate the clinical performance of a novel restorative glass ionomer&#xD;
        (DeltaFil, DMG) in comparison to an established restorative glass ionomer (Riva Self Cure HV,&#xD;
        SDI) in the restoration of Class II cavities in primary molars.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dental caries (tooth decay) remains one of the most prevalent diseases worldwide. It is a&#xD;
        dynamic and continuous process that, if uncontrolled, eventually leads to cavitation and the&#xD;
        need for restorative treatment to maintain the form and function of the tooth.Today there are&#xD;
        many possibilities for direct restorations, e.g. resin composites, compomers, resin-modified&#xD;
        glass ionomer cements (RMGICs) and glass ionomer cements (GICs), which all offer their own&#xD;
        advantages and disadvantages.&#xD;
  &#xD;
        GIC are particularly suitable for treatments in young patients due to their high&#xD;
        biocompatibility, fluoride release, less moisture and technique sensitivity as well as&#xD;
        compatibility with Atraumatic restorative treatment (ART) treatment. However, these materials&#xD;
        have lower mechanical properties compared to other restorative materials, which negatively&#xD;
        affects the survival rate when placed in load bearing areas. Fracture, loss and wear being&#xD;
        the most common causes for failure.&#xD;
  &#xD;
        This randomized, controlled non-inferiority trial aims to evaluate the performance of the new&#xD;
        restorative glass ionomer DeltaFil, that offers an increased fracture toughness, in&#xD;
        comparison to an established restorative glass-ionomer (Riva Self Cure HV).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2030</completion_date>
    <primary_completion_date type="Anticipated">August 2027</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>Noninferiority trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Survival rate of Class II restorations</measure>
      <time_frame>24 months</time_frame>
      <description>Restorations are clinically assessed using the Fédération Dentaire Internationale (FDI) criteria. A &quot;surviving&quot; restoration is defined as a restoration that is still present at the time of evaluation and has no individual FDI criteria with a score of 5 (clinically poor).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Survival rate of Class II restorations</measure>
      <time_frame>6, 12, 36, 48 and 60 months</time_frame>
      <description>Restorations are clinically assessed using the FDI criteria. A &quot;surviving&quot; restoration is defined as a restoration that is still present at the time of evaluation and has no individual FDI criteria with a score of 5 (clinically poor).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Individual FDI parameter assessment</measure>
      <time_frame>Baseline, 6, 12, 24, 36, 48 and 60 months</time_frame>
      <description>Restorations are clinically assessed using the FDI criteria. Specifically, the following criteria are assessed individually on a scale from 1 &quot;very good&quot; to 5 &quot;clinicially poor&quot;:&#xD;
  Esthetic properties (Surface Luster; Surface Staining; Color Match; Anatomical Form); Functional properties (Fractures and Retention; Wear; Approximal Contact Point and Contour; Patient view); Biological properties (Postoperative Hypersensitivity &amp; Tooth Vitality; Recurrence of Caries, Erosion, Abfraction; Periodontal Response; Tooth Integrity;Adjacent mucosa)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Caries Experience</measure>
      <time_frame>Baseline, 6, 12, 24, 36, 48 and 60 months</time_frame>
      <description>To assess caries experience the dmft score will be recorded. dmft refers to the number of primary teeth (t) with either decay (d), missing due to caries (m) or a filling (f).</description>
    </other_outcome>
    <other_outcome>
      <measure>Oral Hygiene</measure>
      <time_frame>Baseline, 6, 12, 24, 36, 48 and 60 months</time_frame>
      <description>Oral hygiene will be assessed using the Oral Hygiene Index-Simplified (OHI-S).</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Dental Caries</condition>
    <arm_group>
      <arm_group_label>DeltaFil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Class II restorations are placed in primary molars after conventional cavity preparation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Riva Self Cure HV</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Class II restorations are placed in primary molars after conventional cavity preparation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DeltaFil</intervention_name>
      <description>Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using DeltaFil conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (DeltaFil). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.</description>
      <arm_group_label>DeltaFil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Riva Self Cure HV</intervention_name>
      <description>Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using Riva conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (Riva Self Cure HV). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.</description>
      <arm_group_label>Riva Self Cure HV</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 1 and up to 3 primary molars with either International Caries Detection and&#xD;
               Assessment System (ICDAS) lesions stage 2-5 or preexisting restorations requiring&#xD;
               placement/replacement of Class II restorations&#xD;
  &#xD;
            -  Defects limited to occlusal-proximal surface, with cavity sizes smaller than 3 mm&#xD;
               mesio-distally and 3 mm in the occluso-cervical and bucco-lingual directions measured&#xD;
               with a World Health Organization (WHO)-graded periodontal probe&#xD;
  &#xD;
            -  Teeth should have both adjoining and their antagonist teeth present. After restoration&#xD;
               the restored tooth should enable appropriate proximal contacts on both mesial and&#xD;
               distal surfaces after setting of the class II restoration and be in occlusion with the&#xD;
               antagonist tooth&#xD;
  &#xD;
            -  Good access&#xD;
  &#xD;
            -  Good general health (ASA I, II)&#xD;
  &#xD;
            -  Good oral hygiene (OHI-S &lt; 1.9)&#xD;
  &#xD;
            -  Guardians have given informed consent&#xD;
  &#xD;
            -  Child is cooperative and assented&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known allergy/ sensitivity to GIC or other materials used in this study&#xD;
  &#xD;
            -  Space maintainers or orthodontic appliances&#xD;
  &#xD;
            -  Tooth has a caries lesion or restoration other than those included in the study&#xD;
  &#xD;
            -  Tooth has pathological mobility&#xD;
  &#xD;
            -  Tooth has preexisting developmental defects&#xD;
  &#xD;
            -  Tooth with pulp exposure or indication for endodontic treatment&#xD;
  &#xD;
            -  Pain, fistula or abscess related to the selected tooth&#xD;
  &#xD;
            -  Obvious signs of parafunctional habits (e.g. bruxism)&#xD;
  &#xD;
            -  Participation in another study&#xD;
  &#xD;
            -  Incapable to participate in the recall visits at the university hospital&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Susanne Effenberger, Dr.</last_name>
      <role>Study Chair</role>
      <affiliation>DMG Dental Material Gesellschaft mbH</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marcus Cebula, Dr.</last_name>
      <phone>+494084006</phone>
      <phone_ext>232</phone_ext>
      <email>mcebula@mtcompanies.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Susanne Effenberger, Dr.</last_name>
      <email>seffenberger@mtcompanies.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic</name>
        <address>
          <city>Petrópolis</city>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute</name>
        <address>
          <city>Coimbra</city>
          <country>Portugal</country>
        </address>
      </facility>
      <contact>
        <last_name>Ana Luísa Costa, Prof.</last_name>
        <email>aluisacosta@sapo.pt</email>
      </contact>
      <contact_backup>
        <last_name>Maria Teresa Xavier, Prof.</last_name>
        <email>xavier.teresa@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Ana Luísa Costa, Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Maria Teresa Xavier, Prof.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Brazil</country>
      <country>Portugal</country>
    </location_countries>
    <reference>
      <citation>Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.</citation>
      <PMID>20628774</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Primary Dentition</keyword>
    <keyword>Glass ionomer cements</keyword>
    <keyword>Posterior Class II restorations</keyword>
    <keyword>DeltaFil</keyword>
    <keyword>Riva Self Cure HV</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>
  
  
text: 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/NCT05965297
  org study id: DeltaFill
  nct id: NCT05965297
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will investigate the clinical performance of a novel restorative glass ionomer
        (DeltaFil, DMG) in comparison to an established restorative glass ionomer (Riva Self Cure HV,
        SDI) in the restoration of Class II cavities in primary molars.
  Dental caries (tooth decay) remains one of the most prevalent diseases worldwide. It is a
        dynamic and continuous process that, if uncontrolled, eventually leads to cavitation and the
        need for restorative treatment to maintain the form and function of the tooth.Today there are
        many possibilities for direct restorations, e.g. resin composites, compomers, resin-modified
        glass ionomer cements (RMGICs) and glass ionomer cements (GICs), which all offer their own
        advantages and disadvantages.
  
        GIC are particularly suitable for treatments in young patients due to their high
        biocompatibility, fluoride release, less moisture and technique sensitivity as well as
        compatibility with Atraumatic restorative treatment (ART) treatment. However, these materials
        have lower mechanical properties compared to other restorative materials, which negatively
        affects the survival rate when placed in load bearing areas. Fracture, loss and wear being
        the most common causes for failure.
  
        This randomized, controlled non-inferiority trial aims to evaluate the performance of the new
        restorative glass ionomer DeltaFil, that offers an increased fracture toughness, in
        comparison to an established restorative glass-ionomer (Riva Self Cure HV).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Noninferiority trial
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Survival rate of Class II restorations
  time frame: 24 months
  description: Restorations are clinically assessed using the Fédération Dentaire Internationale (FDI) criteria. A "surviving" restoration is defined as a restoration that is still present at the time of evaluation and has no individual FDI criteria with a score of 5 (clinically poor).
  measure: Survival rate of Class II restorations
  time frame: 6, 12, 36, 48 and 60 months
  description: Restorations are clinically assessed using the FDI criteria. A "surviving" restoration is defined as a restoration that is still present at the time of evaluation and has no individual FDI criteria with a score of 5 (clinically poor).
  measure: Individual FDI parameter assessment
  time frame: Baseline, 6, 12, 24, 36, 48 and 60 months
  description: Restorations are clinically assessed using the FDI criteria. Specifically, the following criteria are assessed individually on a scale from 1 "very good" to 5 "clinicially poor":
  Esthetic properties (Surface Luster; Surface Staining; Color Match; Anatomical Form); Functional properties (Fractures and Retention; Wear; Approximal Contact Point and Contour; Patient view); Biological properties (Postoperative Hypersensitivity & Tooth Vitality; Recurrence of Caries, Erosion, Abfraction; Periodontal Response; Tooth Integrity;Adjacent mucosa)
  measure: Caries Experience
  time frame: Baseline, 6, 12, 24, 36, 48 and 60 months
  description: To assess caries experience the dmft score will be recorded. dmft refers to the number of primary teeth (t) with either decay (d), missing due to caries (m) or a filling (f).
  measure: Oral Hygiene
  time frame: Baseline, 6, 12, 24, 36, 48 and 60 months
  description: Oral hygiene will be assessed using the Oral Hygiene Index-Simplified (OHI-S).
  arm group label: DeltaFil
  arm group type: Experimental
  description: Class II restorations are placed in primary molars after conventional cavity preparation.
  arm group label: Riva Self Cure HV
  arm group type: Active Comparator
  description: Class II restorations are placed in primary molars after conventional cavity preparation.
  intervention type: Device
  intervention name: DeltaFil
  description: Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using DeltaFil conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (DeltaFil). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.
  arm group label: DeltaFil
  intervention type: Device
  intervention name: Riva Self Cure HV
  description: Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using Riva conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (Riva Self Cure HV). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.
  arm group label: Riva Self Cure HV
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 8 Years
  healthy volunteers: No
  last name: Susanne Effenberger, Dr.
  role: Study Chair
  affiliation: DMG Dental Material Gesellschaft mbH
  last name: Marcus Cebula, Dr.
  phone: +494084006
  phone ext: 232
  email: mcebula@mtcompanies.com
  last name: Susanne Effenberger, Dr.
  email: seffenberger@mtcompanies.com
  facility: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Brazil
  country: Portugal
  citation: Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
  PMID: 20628774
  responsible party type: Sponsor
  mesh term: Dental Caries