<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/NCT04488380</url>
  </required_header>
  <id_info>
    <org_study_id>Restorative Glass Ionomer</org_study_id>
    <nct_id>NCT04488380</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Glass Ionomer Versus Resin Composite Restorations</brief_title>
  <official_title>Clinical Performance of Glass Ionomer Versus Resin Composite Restorations Performed Without Rubber-Dam Isolation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tokat Gaziosmanpasa University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Izmir Katip Celebi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tokat Gaziosmanpasa University</source>
  <brief_summary>
    <textblock>
      The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical&#xD;
      trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and&#xD;
      nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in&#xD;
      patients at risk for salivary contamination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26&#xD;
      females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer&#xD;
      (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment&#xD;
      group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in&#xD;
      the control group. Clinical evaluations of the restorations were performed at 1-week,&#xD;
      6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were&#xD;
      analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2015</start_date>
  <completion_date type="Actual">April 20, 2016</completion_date>
  <primary_completion_date type="Actual">April 20, 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>
    <intervention_model_description>One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surface lustre of dental restorations</measure>
    <time_frame>Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed</time_frame>
    <description>Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. Lustre comparable to enamel, 2. Slightly dull, not noticeable from speaking distance, 3.Dull surface but acceptable if covered with film of saliva, 4. Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary, 5. Very rough, unacceptable plaque retentive surface.).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Staining restoration surface and restoration margin</measure>
    <time_frame>Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed</time_frame>
    <description>Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No surface staining, no marginal staining, 2. Minor surface staining, minor marginal staining easily removable by polishing, 3. oderate surface staining and moderate marginal staining that may also present on other teeth, not esthetically unacceptable, 4. Unacceptable surface staining on the restoration and major intervention necessary for improvement and Pronounced marginal staining; major intervention necessary for improvement, 5. Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention and deep marginal staining, not accessible for intervention.).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fracture of material and retention</measure>
    <time_frame>Changes of dental restorations regarding Fracture of material and retention were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed</time_frame>
    <description>Fracture of material and retention of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No fractures / cracks, 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact, 4. Material chip fractures which damage marginal quality or, approximal contacts. 5. (Partial or complete) loss of restoration or multiple fractures.).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence of caries</measure>
    <time_frame>Changes of dental restorations regarding recurrence of caries were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed</time_frame>
    <description>Recurrence of caries were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No secondary or primary caries 2. Small and localized. 3 Larger areas of 1. Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries Localized and accessible can be repaired, 5. Deep caries or exposed dentine that is not accessible for repair of restoration.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>high-viscosity glass ionomer restoration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One of the carious mandibular 2nd molar teeth (according to randomisation) will be restored with high-viscosity glass ionomer restoration (Equia, GC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nano-hybrid composite resin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One of the carious mandibular 2nd molar teeth will be restored with nano-hybrid composite resin (GrandioSO, Voco)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dental restoration</intervention_name>
    <description>Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin</description>
    <arm_group_label>high-viscosity glass ionomer restoration</arm_group_label>
    <arm_group_label>nano-hybrid composite resin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  good health and oral hygiene,&#xD;
&#xD;
          -  occlusal carious lesions on both mandibular second molars,&#xD;
&#xD;
          -  mandibular second molars with mesial and occlusal contacts,&#xD;
&#xD;
          -  contraindication to the use of rubber dam,&#xD;
&#xD;
          -  the ability to return for periodic follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  restoration on mandibular second molars.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25.</citation>
    <PMID>31351909</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>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tokat Gaziosmanpasa University</investigator_affiliation>
    <investigator_full_name>Huseyin Hatirli</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>restorative glass ionomer</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>Undecided</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/NCT04488380
org study id: Restorative Glass Ionomer
nct id: NCT04488380
lead sponsor: 
collaborator: 
The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical
      trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and
      nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in
      patients at risk for salivary contamination.
Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26
      females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer
      (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment
      group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in
      the control group. Clinical evaluations of the restorations were performed at 1-week,
      6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were
      analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Surface lustre of dental restorations
time frame: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
description: Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. Lustre comparable to enamel, 2. Slightly dull, not noticeable from speaking distance, 3.Dull surface but acceptable if covered with film of saliva, 4. Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary, 5. Very rough, unacceptable plaque retentive surface.).
measure: Staining restoration surface and restoration margin
time frame: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
description: Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No surface staining, no marginal staining, 2. Minor surface staining, minor marginal staining easily removable by polishing, 3. oderate surface staining and moderate marginal staining that may also present on other teeth, not esthetically unacceptable, 4. Unacceptable surface staining on the restoration and major intervention necessary for improvement and Pronounced marginal staining; major intervention necessary for improvement, 5. Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention and deep marginal staining, not accessible for intervention.).
measure: Fracture of material and retention
time frame: Changes of dental restorations regarding Fracture of material and retention were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
description: Fracture of material and retention of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No fractures / cracks, 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact, 4. Material chip fractures which damage marginal quality or, approximal contacts. 5. (Partial or complete) loss of restoration or multiple fractures.).
measure: Recurrence of caries
time frame: Changes of dental restorations regarding recurrence of caries were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
description: Recurrence of caries were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No secondary or primary caries 2. Small and localized. 3 Larger areas of 1. Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries Localized and accessible can be repaired, 5. Deep caries or exposed dentine that is not accessible for repair of restoration.)
arm group label: high-viscosity glass ionomer restoration
arm group type: Experimental
description: One of the carious mandibular 2nd molar teeth (according to randomisation) will be restored with high-viscosity glass ionomer restoration (Equia, GC)
arm group label: nano-hybrid composite resin
arm group type: Experimental
description: One of the carious mandibular 2nd molar teeth will be restored with nano-hybrid composite resin (GrandioSO, Voco)
intervention type: Other
intervention name: dental restoration
description: Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin
arm group label: high-viscosity glass ionomer restoration
arm group label: nano-hybrid composite resin
criteria: 
gender: All
minimum age: 15 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25.
PMID: 31351909
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: Tokat Gaziosmanpasa University
investigator full name: Huseyin Hatirli
investigator title: Assistant Professor
mesh term: Dental Caries
sharing ipd: Undecided