<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/NCT04401618</url>
  </required_header>
  <id_info>
    <org_study_id>107864</org_study_id>
    <nct_id>NCT04401618</nct_id>
  </id_info>
  <brief_title>Retrospective Evaluation of RMGI/GI Class V Restorations</brief_title>
  <official_title>Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brief Summary: Retrospective study to evaluate the clinical performance of two restorative&#xD;
      materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V&#xD;
      carious and non-carious cervical lesions restored by dental students.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer&#xD;
      (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious&#xD;
      cervical lesions restored by dental students. Ninety-six (96) restorations performed with&#xD;
      either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS&#xD;
      (United States Public Health Systems) criteria by two independent investigators at two&#xD;
      follow-up evaluations (two years apart). The Fisher statistical test was used to compare&#xD;
      USPHS criteria and examine significant differences by setting p&lt;0.05 for statistical&#xD;
      significance and the Kaplan-Meier algorithm was used to calculate the survival probability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-Operative Sensitivity</measure>
    <time_frame>2 years</time_frame>
    <description>Absence of sensitivity to pressure, cold or hot temperature on the teeth restored (checked verbally by inquiring the patient about the presence or absence of pain in the presence of stimuli)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Secondary Caries</measure>
    <time_frame>2 years</time_frame>
    <description>No visual evidence of dark, deep discolouration or cavitation adjacent to the restoration (visually and manually checked with the tip of a dental hand instrument - explorer)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anatomic Form</measure>
    <time_frame>2 years</time_frame>
    <description>Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Color match</measure>
    <time_frame>2 years</time_frame>
    <description>No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surface Roughness</measure>
    <time_frame>2 years</time_frame>
    <description>Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Marginal Discolouration</measure>
    <time_frame>2 years</time_frame>
    <description>No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Marginal Integrity</measure>
    <time_frame>2 years</time_frame>
    <description>Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Material, Dental</condition>
  <arm_group>
    <arm_group_label>Class V RMGI Restorations</arm_group_label>
    <description>Resin-modified glass ionomer (RMGI - Fuji 2 LC) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Class V Glass ionomer - GIC Restorations</arm_group_label>
    <description>Glass ionomer (GI - Fuji 9) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrospective evaluation of RMGI and GIC Class V Restorations</intervention_name>
    <description>Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.</description>
    <arm_group_label>Class V Glass ionomer - GIC Restorations</arm_group_label>
    <arm_group_label>Class V RMGI Restorations</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults that have Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental&#xD;
        students at the Schulich Dental Clinic over the last three years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students over&#xD;
        the last three years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Class V Restorations placed outside of the dental school&#xD;
&#xD;
          -  Class V Restorations that used other restorative materials Class V Ionomer&#xD;
             restorations (RMGI and GIC0 placed before three years on the time of evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Jacinta Santos, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schulich Dentistry-Western University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schulich Medicine and Dentistry - Western University</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Santos MJ, Ari N, Steele S, Costella J, Banting D. Retention of tooth-colored restorations in non-carious cervical lesions--a systematic review. Clin Oral Investig. 2014;18(5):1369-81. doi: 10.1007/s00784-014-1220-7. Epub 2014 Mar 27.</citation>
    <PMID>24671713</PMID>
  </reference>
  <reference>
    <citation>Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-colored materials in cervical lesions. Am J Dent. 1996 Feb;9(1):15-8.</citation>
    <PMID>9002808</PMID>
  </reference>
  <reference>
    <citation>Franco EB, Benetti AR, Ishikiriama SK, Santiago SL, Lauris JR, Jorge MF, Navarro MF. 5-year clinical performance of resin composite versus resin modified glass ionomer restorative system in non-carious cervical lesions. Oper Dent. 2006 Jul-Aug;31(4):403-8. doi: 10.2341/05-87.</citation>
    <PMID>16924979</PMID>
  </reference>
  <reference>
    <citation>van Dijken JW. Retention of a resin-modified glass ionomer adhesive in non-carious cervical lesions. A 6-year follow-up. J Dent. 2005 Aug;33(7):541-7. doi: 10.1016/j.jdent.2004.11.015. Epub 2005 Feb 8.</citation>
    <PMID>16005793</PMID>
  </reference>
  <reference>
    <citation>Imbery TA, Namboodiri A, Duncan A, Amos R, Best AM, Moon PC. Evaluating dentin surface treatments for resin-modified glass ionomer restorative materials. Oper Dent. 2013 Jul-Aug;38(4):429-38. doi: 10.2341/12-162-L. Epub 2012 Oct 22.</citation>
    <PMID>23088188</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Maria Jacinta Santos</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Glass-Ionomer Cement</keyword>
  <keyword>Polyacid-Modified Composite Resin</keyword>
  <keyword>Dental School</keyword>
  <!-- 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/NCT04401618
org study id: 107864
nct id: NCT04401618
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Brief Summary: Retrospective study to evaluate the clinical performance of two restorative
      materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V
      carious and non-carious cervical lesions restored by dental students.
The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer
      (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious
      cervical lesions restored by dental students. Ninety-six (96) restorations performed with
      either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS
      (United States Public Health Systems) criteria by two independent investigators at two
      follow-up evaluations (two years apart). The Fisher statistical test was used to compare
      USPHS criteria and examine significant differences by setting p<0.05 for statistical
      significance and the Kaplan-Meier algorithm was used to calculate the survival probability.
observational model: Other
time perspective: Retrospective
measure: Post-Operative Sensitivity
time frame: 2 years
description: Absence of sensitivity to pressure, cold or hot temperature on the teeth restored (checked verbally by inquiring the patient about the presence or absence of pain in the presence of stimuli)
measure: Secondary Caries
time frame: 2 years
description: No visual evidence of dark, deep discolouration or cavitation adjacent to the restoration (visually and manually checked with the tip of a dental hand instrument - explorer)
measure: Anatomic Form
time frame: 2 years
description: Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)
measure: Color match
time frame: 2 years
description: No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)
measure: Surface Roughness
time frame: 2 years
description: Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)
measure: Marginal Discolouration
time frame: 2 years
description: No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)
measure: Marginal Integrity
time frame: 2 years
description: Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)
arm group label: Class V RMGI Restorations
description: Resin-modified glass ionomer (RMGI - Fuji 2 LC) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.
arm group label: Class V Glass ionomer - GIC Restorations
description: Glass ionomer (GI - Fuji 9) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes.
intervention type: Other
intervention name: Retrospective evaluation of RMGI and GIC Class V Restorations
description: Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.
arm group label: Class V Glass ionomer - GIC Restorations
arm group label: Class V RMGI Restorations
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Jacinta Santos, Ph.D
role: Principal Investigator
affiliation: Schulich Dentistry-Western University
facility: 
country: Canada
citation: Santos MJ, Ari N, Steele S, Costella J, Banting D. Retention of tooth-colored restorations in non-carious cervical lesions--a systematic review. Clin Oral Investig. 2014;18(5):1369-81. doi: 10.1007/s00784-014-1220-7. Epub 2014 Mar 27.
PMID: 24671713
citation: Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-colored materials in cervical lesions. Am J Dent. 1996 Feb;9(1):15-8.
PMID: 9002808
citation: Franco EB, Benetti AR, Ishikiriama SK, Santiago SL, Lauris JR, Jorge MF, Navarro MF. 5-year clinical performance of resin composite versus resin modified glass ionomer restorative system in non-carious cervical lesions. Oper Dent. 2006 Jul-Aug;31(4):403-8. doi: 10.2341/05-87.
PMID: 16924979
citation: van Dijken JW. Retention of a resin-modified glass ionomer adhesive in non-carious cervical lesions. A 6-year follow-up. J Dent. 2005 Aug;33(7):541-7. doi: 10.1016/j.jdent.2004.11.015. Epub 2005 Feb 8.
PMID: 16005793
citation: Imbery TA, Namboodiri A, Duncan A, Amos R, Best AM, Moon PC. Evaluating dentin surface treatments for resin-modified glass ionomer restorative materials. Oper Dent. 2013 Jul-Aug;38(4):429-38. doi: 10.2341/12-162-L. Epub 2012 Oct 22.
PMID: 23088188
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Maria Jacinta Santos
investigator title: Associate Professor