<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/NCT02991664</url>
  </required_header>
  <id_info>
    <org_study_id>Equia Forte_G-aenial Posterior</org_study_id>
    <nct_id>NCT02991664</nct_id>
  </id_info>
  <brief_title>Clinical Performance of a Glass-ionomer Restorative System in Extended-sized Cavities</brief_title>
  <official_title>Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations in Extended Sized Class 2 Cavities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this clinical trial was to compare the clinical performances of a glass ionomer&#xD;
      restorative system with a micro hybrid resin based composite in extended sized class II&#xD;
      cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative&#xD;
      system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). Restorations were&#xD;
      evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria.&#xD;
      Data were analyzed with Cohcran's Q and McNemar's tests (p&lt;0.05).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the introduction of glass ionomers many modifications of these materials have been&#xD;
      performed over the years. Compared to other permanent filling materials like resin-based&#xD;
      composites, glass ionomers show several advantages, such as the ability to adhere to moist&#xD;
      enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So,&#xD;
      it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based&#xD;
      composites in posterior teeth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2015</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.</measure>
    <time_frame>From baseline to 6 year the change of restorations was evaluated</time_frame>
    <description>Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (&gt; 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.</measure>
    <time_frame>From baseline to 6 year the change of restorations was evaluated</time_frame>
    <description>Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.</measure>
    <time_frame>From baseline to 6 year the change of restorations was evaluated</time_frame>
    <description>Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.</measure>
    <time_frame>From baseline to 6 year the change of restorations was evaluated</time_frame>
    <description>Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change</measure>
    <time_frame>From baseline to 6 year the change of restorations was evaluated</time_frame>
    <description>Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Dental Caries Class II</condition>
  <arm_group>
    <arm_group_label>Equia Forte, randomly applied</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placing glass ionomer restorations, the dentin and enamel of cavities were washed, and briefly dried. Equia Forte Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Forte Coat was applied and photocured for 20 seconds using a photo-curing light.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G-aenial Posterior, randomly applied</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After etching procedure, the enamel and dentin were conditioned with G-aenial adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, G-aenial posterior composite resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Equia Forte</intervention_name>
    <description>Glass ionomer restorative system</description>
    <arm_group_label>Equia Forte, randomly applied</arm_group_label>
    <other_name>Glass ionomer restorative system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>G-aenial Posterior</intervention_name>
    <description>Micro hybrid composite resin</description>
    <arm_group_label>G-aenial Posterior, randomly applied</arm_group_label>
    <other_name>Micro hybrid composite resin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. a need for at least two but not more than four posterior toothcolored restorations;&#xD;
&#xD;
          2. the presence of teeth to be restored in occlusion;&#xD;
&#xD;
          3. teeth that were symptomless and vital;&#xD;
&#xD;
          4. a normal periodontal status;&#xD;
&#xD;
          5. a good likelihood of recall availability.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. partly erupted teeth;&#xD;
&#xD;
          2. absence of adjacent and antagonist teeth&#xD;
&#xD;
          3. poor periodontal status;&#xD;
&#xD;
          4. adverse medical history;&#xD;
&#xD;
          5. potential behavioral problems.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sevil Gurgan, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University School of Dentistry</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University School of Dentistry</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.</citation>
    <PMID>25299703</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 10, 2016</last_update_submitted>
  <last_update_submitted_qc>December 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Zeynep Bilge Kutuk</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>glass ionomer cement</keyword>
  <keyword>composite resin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <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/NCT02991664
org study id: Equia Forte_G-aenial Posterior
nct id: NCT02991664
lead sponsor: 
has dmc: Yes
The aim of this clinical trial was to compare the clinical performances of a glass ionomer
      restorative system with a micro hybrid resin based composite in extended sized class II
      cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative
      system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). Restorations were
      evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria.
      Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).
Since the introduction of glass ionomers many modifications of these materials have been
      performed over the years. Compared to other permanent filling materials like resin-based
      composites, glass ionomers show several advantages, such as the ability to adhere to moist
      enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So,
      it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based
      composites in posterior teeth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.
time frame: From baseline to 6 year the change of restorations was evaluated
description: Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100μ) with discoloration (removable) Bravo: Marginal gap (> 100μ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.
time frame: From baseline to 6 year the change of restorations was evaluated
description: Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.
time frame: From baseline to 6 year the change of restorations was evaluated
description: Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.
time frame: From baseline to 6 year the change of restorations was evaluated
description: Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change
time frame: From baseline to 6 year the change of restorations was evaluated
description: Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
arm group label: Equia Forte, randomly applied
arm group type: Active Comparator
description: Placing glass ionomer restorations, the dentin and enamel of cavities were washed, and briefly dried. Equia Forte Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Forte Coat was applied and photocured for 20 seconds using a photo-curing light.
arm group label: G-aenial Posterior, randomly applied
arm group type: Active Comparator
description: After etching procedure, the enamel and dentin were conditioned with G-aenial adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, G-aenial posterior composite resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
intervention type: Other
intervention name: Equia Forte
description: Glass ionomer restorative system
arm group label: Equia Forte, randomly applied
other name: Glass ionomer restorative system
intervention type: Other
intervention name: G-aenial Posterior
description: Micro hybrid composite resin
arm group label: G-aenial Posterior, randomly applied
other name: Micro hybrid composite resin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sevil Gurgan, Professor
role: Study Director
affiliation: Hacettepe University School of Dentistry
facility: 
country: Turkey
citation: Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.
PMID: 25299703
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Zeynep Bilge Kutuk
investigator title: Research Assistant
mesh term: Dental Caries
sharing ipd: No