<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/NCT03822403</url>
  </required_header>
  <id_info>
    <org_study_id>HEK 09/112-11</org_study_id>
    <nct_id>NCT03822403</nct_id>
  </id_info>
  <brief_title>Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation</brief_title>
  <official_title>Randomized, Controlled Clinical Evaluation of Glass Ionomer System vs Composite Posterior Restorations</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </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 class I and class II&#xD;
      cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored&#xD;
      with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct).&#xD;
      Restorations were evaluated at baseline and yearly during 9 years according to the&#xD;
      modified-USPHS criteria. 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>Completed</overall_status>
  <start_date type="Actual">May 1, 2009</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>
    <masking_description>Double (Participant, Investigator)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Marginal adaptation</measure>
    <time_frame>From baseline to 9 year the change of restorations was evaluated</time_frame>
    <description>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. 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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>marginal discoloration</measure>
    <time_frame>From baseline to 9 year the change of restorations was evaluated</time_frame>
    <description>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration. 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>retention rate</measure>
    <time_frame>From baseline to 9 year the change of restorations was evaluated</time_frame>
    <description>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed .&#xD;
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>anatomic form</measure>
    <time_frame>From baseline to 9 year the change of restorations was evaluated</time_frame>
    <description>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form. Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed .&#xD;
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>color change</measure>
    <time_frame>From baseline to 9 year the change of restorations was evaluated</time_frame>
    <description>Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change. 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 failed and needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency.&#xD;
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">54</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>EQUIA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EQUIA Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia 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 Coat was applied and photocured for 20 seconds using a photo-curing light.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gradia Direct Posterior</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gradia Direct Posterior The enamel and dentin were conditioned with G-Bond 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, Gradia Direct Posterior 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>Device</intervention_type>
    <intervention_name>EQUIA</intervention_name>
    <description>Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia 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 Coat was applied and photocured for 20 seconds using a photo-curing light.</description>
    <arm_group_label>EQUIA</arm_group_label>
    <other_name>Glass ionomer restorative system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gradia Direct Posterior</intervention_name>
    <description>The enamel and dentin were conditioned with G-Bond 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, Gradia Direct Posterior 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_label>Gradia Direct Posterior</arm_group_label>
    <other_name>Micro hybrid composite</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>
  <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>
  <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>
  </reference>
  <reference>
    <citation>Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Clinical performance of a glass ionomer restorative system: a 6-year evaluation. Clin Oral Investig. 2017 Sep;21(7):2335-2343. doi: 10.1007/s00784-016-2028-4. Epub 2016 Dec 20.</citation>
    <PMID>28000039</PMID>
  </reference>
  <reference>
    <citation>Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.</citation>
    <PMID>27571238</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</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>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>glass ionomer</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>Yes</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/NCT03822403
org study id: HEK 09/112-11
nct id: NCT03822403
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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 class I and class II
      cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored
      with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct).
      Restorations were evaluated at baseline and yearly during 9 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)
masking description: Double (Participant, Investigator)
measure: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Observers evaluated the restorations was performed using the modified United State Public Health Service criteria Marginal adaptation
time frame: From baseline to 9 year the change of restorations was evaluated
description: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. 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)
measure: marginal discoloration
time frame: From baseline to 9 year the change of restorations was evaluated
description: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration. 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: retention rate
time frame: From baseline to 9 year the change of restorations was evaluated
description: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. 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: anatomic form
time frame: From baseline to 9 year the change of restorations was evaluated
description: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form. 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: color change
time frame: From baseline to 9 year the change of restorations was evaluated
description: Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change. 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 failed and 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
arm group type: Active Comparator
description: EQUIA Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia 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 Coat was applied and photocured for 20 seconds using a photo-curing light.
arm group label: Gradia Direct Posterior
arm group type: Active Comparator
description: Gradia Direct Posterior The enamel and dentin were conditioned with G-Bond 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, Gradia Direct Posterior 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: Device
intervention name: EQUIA
description: Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia 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 Coat was applied and photocured for 20 seconds using a photo-curing light.
arm group label: EQUIA
other name: Glass ionomer restorative system
intervention type: Device
intervention name: Gradia Direct Posterior
description: The enamel and dentin were conditioned with G-Bond 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, Gradia Direct Posterior 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.
arm group label: Gradia Direct Posterior
other name: Micro hybrid composite
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
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
citation: Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Clinical performance of a glass ionomer restorative system: a 6-year evaluation. Clin Oral Investig. 2017 Sep;21(7):2335-2343. doi: 10.1007/s00784-016-2028-4. Epub 2016 Dec 20.
PMID: 28000039
citation: Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.
PMID: 27571238
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Zeynep Bilge Kutuk
investigator title: Assistant Professor
mesh term: Dental Caries
sharing ipd: Yes